A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma
A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combination of FF/VI, Administered Once-daily Via a Dry Powder Inhaler in Subjects With Inadequately Controlled Asthma
2 other identifiers
interventional
2,436
15 countries
409
Brief Summary
A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. This is a phase III, multi-center, active-controlled, double-blind, parallel-group study to compare the efficacy, safety and tolerability of the FDC of FF/UMEC/VI with the FDC of FF/VI. This study has 5 phases: Pre-Screening (Visit 0), Screening/Run-in, Enrolment/Stabilization, Randomization/Treatment, and Follow up. At Visit 1 (Screening), subjects meeting all protocol defined inclusion/exclusion criteria will enter a 3-week run-in period and will receive fixed dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) (fluticasone/salmeterol, 250/50 micrograms (mcg), via the DISKUS® DPI) one inhalation twice a day. At Visit 2 (Enrolment), eligible subjects will be enrolled into the 2-week stabilization period to receive FF/VI (100/25 mcg via the ELLIPTA DPI once a day, in the morning). At the conclusion of the stabilization period (Visit 3), all subjects who meet the pre-defined randomization criteria will be randomized 1:1:1:1:1:1 during the treatment period to receive either FF/UMEC/VI (100/62.5/25 mcg; 200/62.5/25 mcg; 100/31.25/25 mcg; 200/31.25/25 mcg) or FF/VI (100/25 mcg; 200/25 mcg) via the ELLIPTA DPI once daily in the morning. The duration of the treatment period is variable but will be a minimum of 24 weeks and a maximum of 52 weeks. Subjects will have up to 6 on-treatment clinic visits scheduled at Visits 3, 4, 5, 6, 7 and 8/End of Study (EOS) (Weeks 0, 4, 12, 24, 36 and 52, respectively). A follow-up visit will be conducted approximately 7 days after the end of treatment period or, if applicable, after the early withdrawal visit. Subjects will be provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study. Approximately 2250 subjects will be randomized, with approximately 375 subjects randomized to each of the 6 double-blind treatment arms to ensure approximately 337 evaluable subjects per treatment arm. DISKUS and ELLIPTA are registered trademarks of GSK groups of companies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Oct 2016
Typical duration for phase_3 asthma
409 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2019
CompletedResults Posted
Study results publicly available
February 21, 2020
CompletedMarch 26, 2021
February 1, 2021
2.4 years
September 12, 2016
February 4, 2020
February 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24
FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value. Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Treatment policy estimand was assessed, including all on- and post-treatment data. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement. Mixed Model Repeated Measures(MMRM) was used.
Baseline (pre-dose at Day 1) and Week 24
Secondary Outcomes (11)
Annualized Rate of Moderate and Severe Asthma Exacerbations
Up to Week 52
Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Study Treatment at Week 24
Baseline (pre-dose at Day 1) and 3 hours post dose at Week 24
Mean Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 24
Baseline (pre-dose at Day 1) and Week 24
Mean Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 24
Baseline (pre-dose at Day 1) and Week 24
Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score Over Weeks 21 to 24 (Inclusive) of the Treatment Period
Baseline (14 days prior to randomization) and Weeks 21 to 24
- +6 more secondary outcomes
Study Arms (6)
FF/UMEC/VI (100/31.25/25) mcg closed triple therapy
EXPERIMENTALSubjects will receive FF/UMEC/VI (100/31.25/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
FF/UMEC/VI (100/62.5/25) mcg closed triple therapy
EXPERIMENTALSubjects will receive FF/UMEC/VI (100/62.5/25) mcg inhalation powder via DPI, once daily in the morning. Subjects will also receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
FF/UMEC/VI (200/31.25/25) mcg closed triple therapy
EXPERIMENTALSubjects will receive FF/UMEC/VI (200/31.25/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
FF/UMEC/VI (200/62.5/25) mcg closed triple therapy
EXPERIMENTALSubjects may receive FF/UMEC/VI (200/62.5/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
FF/VI (100/25) mcg dual combination therapy
ACTIVE COMPARATORSubjects will receive FF/VI (100/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
FF/VI (200/25) mcg dual combination therapy
ACTIVE COMPARATORSubjects will receive FF/VI (200/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.
Interventions
Dry white powder delivered via the ELLIPTA DPI (one inhalation once-daily \[QD\] in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains VI 25 mcg in each blister.
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains VI 25 mcg in each blister.
Dry white powder delivered via the DISKUS DPI (one inhalation twice daily: one in the morning and one in the evening). The DISKUS DPI holds a strip of 60 blisters; each blister contains FP 250 mcg and 50 mcg of salmeterol.
This is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.
The ELLIPTA device will be used during the stabilization period and the treatment period. The ELLIPTA DPI is a moulded plastic two-sided device that can hold two individual blister strips which contain powder formulation for oral inhalation.
The DISKUS device will be used during the run-in period. The DISKUS DPI is a plastic inhalation delivery system containing a single-foil blister strip of a powder formulation of FSC for oral inhalation.
Albuterol/salbutamol (rescue medication) will be delivered via metered-dose inhaler (MDI) will be used for reversibility testing.
Eligibility Criteria
You may qualify if:
- Age: 18 years of age or older at the time of signing the informed consent.
- Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health at least one year prior to Visit 0.
- Symptomatic: Subjects with inadequately controlled asthma (ACQ-6 score \>=1.5) despite ICS/LABA maintenance therapy at Visit 1.
- Asthma Control: In the 1 year prior to Visit 1
- A documented healthcare contact for acute asthma symptoms or
- A documented temporary change in asthma therapy for acute asthma symptoms, according to a pre-specified asthma action plan (or equivalent)
- Current Asthma Maintenance Therapy: Subjects are eligible if they have required daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of \>250 mcg/day fluticasone proprionate \[FP, or equivalent\]).
- Spirometry: A best pre-bronchodilator morning (ante meridian \[AM\]) FEV1 \>=30% and \<85% of the predicted normal value at Visit 1. Predicted values will be based upon the European Respiratory Society (ERS) Global Lung Function Initiative.
- Reversibility of Disease: airway reversibility defined as \>=12% and \>=200 milliliter (mL) increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1.
- If the subject does not meet the above reversibility criteria at Visit 1 then the reversibility assessment may be repeated once within 7 days of Visit 1 if either criteria a) or b) are met: a) \>=9% increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1. b) Documented evidence of a reversibility assessment within 1 year prior to Visit 1 which demonstrated a post-bronchodilator increase in FEV1 of \>=12% and \>=200 mL.
- Should the subject successfully demonstrate airway reversibility (defined as \>=12% and \>=200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol) at the second attempt then, provided that all other eligibility criteria assessed at Visit 1 are met, the subject may enter the 3-week run-in period.
- Short-Acting beta2 Agonists (SABAs): All subjects must be able to replace their current SABA inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Subjects must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
- Male or eligible Female, defined as having documentation of non-reproductive potential or reproductive potential as follows:
- A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test), not lactating, is not planning on becoming pregnant during the study and at least one of the following conditions applies: Non-reproductive potential defined as pre-menopausal females with documented tubal ligation or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion or hysterectomy or documented bilateral oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile (e.g., age appropriate, \>45 years, in the absence of hormone replacement therapy). In questionable cases for women \<60 years of age, a blood sample with simultaneous follicle stimulating hormone and estradiol falling into the central laboratory's postmenopausal reference range is confirmatory. Females under 60 years of age, who are on hormone replacement therapy (HRT) and whose menopausal status is in doubt, are required to use a highly effective method to avoid pregnancy if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, subjects can resume use of HRT during the study without use of a highly effective method to avoid pregnancy; Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from the screening visit until after the last dose of study medication and completion of the follow-up visit. The Investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
- Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form and in this protocol. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
You may not qualify if:
- Pneumonia: Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
- Asthma Exacerbation: Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit 1. Note: Subjects requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the subject's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification) and they are considered appropriate for enrolment into this study of up to 12 month's duration.
- Chronic Obstructive Pulmonary Disease: Subjects with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, including history of exposure to risk factors (i.e., especially tobacco smoke, occupational dusts and chemicals, smoke from home cooking and heating fuels) and a post-albuterol/salbutamol FEV1/Forced Vital Capacity (FVC) ratio of \<0.70 and a post-albuterol/salbutamol FEV1 of =\<70% of predicted normal values and onset of disease \>=40 years of age.
- Concurrent respiratory disorders: Subjects with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
- Risk Factors for Pneumonia: Immune suppression (e.g., human immunodeficiency virus, Lupus) or other risk factors for pneumonia (e.g., neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis).
- Patients at potentially high risk (e.g., very low body mass index (BMI), severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.
- Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria.
- Clinically significant Electrocardiogram abnormality: Evidence of a clinically significant abnormality in the 12-lead ECG performed during screening. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: Atrial fibrillation (AF) with rapid ventricular rate \>120 Beats Per Minute (BPM); sustained or non-sustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate by Fridericia's formula (QTcF) \>=500 milliseconds (msec) in subjects with QRS \<120 msec and QTcF \>=530 msec in subjects with QRS \>=120 msec.
- Unstable or life threatening cardiac disease: Subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure.
- Antimuscarinic effects: Subjects with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the Investigator the benefit outweighs the risk and that the condition would not contraindicate study participation.
- Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment.
- Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
- Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 6-hour period required prior to spirometry testing at each study visit.
- Tobacco Use: Subjects who are: Current smokers (defined as subjects who have used inhaled tobacco products within the 12 months prior to Visit 1 \[i.e., cigarettes, e-cigarettes/vaping, cigars or pipe tobacco\]) or former smokers with a smoking history of \>=10 pack years (e.g., \>=20 cigarettes/day for 10 years).
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (409)
GSK Investigational Site
Birmingham, Alabama, 35243, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Montgomery, Alabama, 36106, United States
GSK Investigational Site
Gilbert, Arizona, 85234, United States
GSK Investigational Site
Scottsdale, Arizona, 85251, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Canton, California, 44718, United States
GSK Investigational Site
Encinitas, California, 92024, United States
GSK Investigational Site
Escondico, California, 92025, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Huntington Beach, California, 92648, United States
GSK Investigational Site
La Jolla, California, 92093, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Los Angeles, California, 90025, United States
GSK Investigational Site
Oxnard, California, 93030, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Roseville, California, 95661, United States
GSK Investigational Site
San Diego, California, 92103-8415, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Jose, California, 95117, United States
GSK Investigational Site
Aurora, Colorado, 80045, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Denver, Colorado, 80230, United States
GSK Investigational Site
Lafayette, Colorado, 80026, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Brandon, Florida, 33511, United States
GSK Investigational Site
Hollywood, Florida, 33024, United States
GSK Investigational Site
Jupiter, Florida, 33458, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Ocoee, Florida, 34761, United States
GSK Investigational Site
St. Petersburg, Florida, 33709, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Adairsville, Georgia, 30103, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
GSK Investigational Site
River Forest, Illinois, 60305, United States
GSK Investigational Site
Michigan City, Indiana, 46360, United States
GSK Investigational Site
South Bend, Indiana, 46617, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Louisville, Kentucky, 40215, United States
GSK Investigational Site
Owensboro, Kentucky, 42301, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Chevy Chase, Maryland, 20815, United States
GSK Investigational Site
Columbia, Maryland, 21044, United States
GSK Investigational Site
Rochester, Michigan, 48307, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
Lincoln, Nebraska, 68505, United States
GSK Investigational Site
Ocean City, New Jersey, 07712, United States
GSK Investigational Site
Buffalo, New York, 14215-1199, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Charlotte, North Carolina, 28277, United States
GSK Investigational Site
Gastonia, North Carolina, 28054, United States
GSK Investigational Site
High Point, North Carolina, 27262, United States
GSK Investigational Site
Huntersville, North Carolina, 28078, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Shelby, North Carolina, 28150, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27104, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Cincinnati, Ohio, 45242, United States
GSK Investigational Site
Dayton, Ohio, 45419, United States
GSK Investigational Site
Dublin, Ohio, 43016, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97202, United States
GSK Investigational Site
Portland, Oregon, 97223, United States
GSK Investigational Site
Jefferson Hills, Pennsylvania, 15025, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Warwick, Rhode Island, 02886, United States
GSK Investigational Site
Anderson, South Carolina, 29621, United States
GSK Investigational Site
Charleston, South Carolina, 29414, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Spartanburg, South Carolina, 29301, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Hendersonville, Tennessee, 37075, United States
GSK Investigational Site
Austin, Texas, 78726, United States
GSK Investigational Site
Dallas, Texas, 75225, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
El Paso, Texas, 79903, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77058, United States
GSK Investigational Site
Killeen, Texas, 76542, United States
GSK Investigational Site
Lampasas, Texas, 76550, United States
GSK Investigational Site
Live Oak, Texas, 78233, United States
GSK Investigational Site
McKinney, Texas, 75069, United States
GSK Investigational Site
Missouri City, Texas, 77459, United States
GSK Investigational Site
Pharr, Texas, 78577, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
Abingdon, Virginia, 24210, United States
GSK Investigational Site
Richmond, Virginia, 23225, United States
GSK Investigational Site
Williamsburg, Virginia, 23188, United States
GSK Investigational Site
Seattle, Washington, 98115, United States
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1414AIF, Argentina
GSK Investigational Site
Florida, Buenos Aires, 1602, Argentina
GSK Investigational Site
Mar del Plata, Buenos Aires, 7600, Argentina
GSK Investigational Site
Paraná, Buenos Aires, E3100BHK, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, X5003DCE, Argentina
GSK Investigational Site
San Rafael, Mendoza Province, 5600, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, 2000, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000DBS, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000JKR, Argentina
GSK Investigational Site
Berazategui, 1884, Argentina
GSK Investigational Site
Buenos Aires, C1121ABE, Argentina
GSK Investigational Site
Buenos Aires, C1128AAF, Argentina
GSK Investigational Site
Buenos Aires, C1424BSF, Argentina
GSK Investigational Site
Buenos Aires, C1425BEN, Argentina
GSK Investigational Site
Córdoba, 5000, Argentina
GSK Investigational Site
Mendoza, 5500, Argentina
GSK Investigational Site
Mendoza, M5500CCG, Argentina
GSK Investigational Site
San Miguel de Tucumán, 4000, Argentina
GSK Investigational Site
Santa Fe, 3000, Argentina
GSK Investigational Site
Coffs Harbour, New South Wales, 2450, Australia
GSK Investigational Site
Randwick, New South Wales, 2031, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Sherwood, Queensland, 4075, Australia
GSK Investigational Site
Bedford Park, South Australia, 5042, Australia
GSK Investigational Site
Clayton, Victoria, 3169, Australia
GSK Investigational Site
Melbourne, Victoria, 3004, Australia
GSK Investigational Site
Murdoch, Western Australia, 6150, Australia
GSK Investigational Site
Golden Beach, 4551, Australia
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5, Canada
GSK Investigational Site
Ajax, Ontario, L1S 2J5, Canada
GSK Investigational Site
Brampton, Ontario, L6T 0G1, Canada
GSK Investigational Site
Burlington, Ontario, L7N 3V2, Canada
GSK Investigational Site
Hamilton, Ontario, L8L 5G8, Canada
GSK Investigational Site
London, Ontario, N5W 6A2, Canada
GSK Investigational Site
Mississauga, Ontario, L4V 1P1, Canada
GSK Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
GSK Investigational Site
Toronto, Ontario, M3J 2C5, Canada
GSK Investigational Site
Toronto, Ontario, M5T 3A9, Canada
GSK Investigational Site
Toronto, Ontario, M9V 4B4, Canada
GSK Investigational Site
Waterloo, Ontario, N2J1C4, Canada
GSK Investigational Site
Windsor, Ontario, N8X 1T3, Canada
GSK Investigational Site
Windsor, Ontario, N8X 2G1, Canada
GSK Investigational Site
Montreal, Quebec, H4J 1C5, Canada
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Victoriaville, Quebec, G6P 6P6, Canada
GSK Investigational Site
Québec, G1V 4G5, Canada
GSK Investigational Site
Darmstadt, Hesse, 64283, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60389, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Neu-Isenburg, Hesse, 63263, Germany
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45879, Germany
GSK Investigational Site
Rheine, North Rhine-Westphalia, 48431, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068, Germany
GSK Investigational Site
Leipzg, Saxony, 04109, Germany
GSK Investigational Site
Leipzig, Saxony, 04157, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552, Germany
GSK Investigational Site
Schleswig, Schleswig-Holstein, 24837, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 12203, Germany
GSK Investigational Site
Berlin, 13156, Germany
GSK Investigational Site
Hamburg, 22299, Germany
GSK Investigational Site
Bari, Apulia, 70124, Italy
GSK Investigational Site
Eboli (SA), Campania, 84025, Italy
GSK Investigational Site
Parma, Emilia-Romagna, 43125, Italy
GSK Investigational Site
Rome, Lazio, 00168, Italy
GSK Investigational Site
Rome, Lazio, 00189, Italy
GSK Investigational Site
Milan, Lombardy, 20162, Italy
GSK Investigational Site
Pavia, Lombardy, 27100, Italy
GSK Investigational Site
Tradate (VA), Lombardy, 21049, Italy
GSK Investigational Site
Orbassano (TO), Piedmont, 10043, Italy
GSK Investigational Site
Palermo, Sicily, 90146, Italy
GSK Investigational Site
Civitanova Marche (MC), The Marches, 62012, Italy
GSK Investigational Site
Pisa, Tuscany, 56124, Italy
GSK Investigational Site
Aichi, 471-8513, Japan
GSK Investigational Site
Aichi, 488-8585, Japan
GSK Investigational Site
Chiba, 278-0004, Japan
GSK Investigational Site
Fukui, 910-1193, Japan
GSK Investigational Site
Fukui, 910-8526, Japan
GSK Investigational Site
Fukuoka, 802-0052, Japan
GSK Investigational Site
Fukuoka, 802-0083, Japan
GSK Investigational Site
Fukuoka, 805-8508, Japan
GSK Investigational Site
Fukuoka, 811-1394, Japan
GSK Investigational Site
Fukuoka, 814-0180, Japan
GSK Investigational Site
Fukuoka, 816-0813, Japan
GSK Investigational Site
Fukuoka, 832-0059, Japan
GSK Investigational Site
Gifu, 509-6134, Japan
GSK Investigational Site
Hiroshima, 720-0001, Japan
GSK Investigational Site
Hiroshima, 732-0052, Japan
GSK Investigational Site
Hiroshima, 734-8530, Japan
GSK Investigational Site
Hiroshima, 735-8585, Japan
GSK Investigational Site
Hiroshima, 737-0193, Japan
GSK Investigational Site
Hokkaido, 001-0901, Japan
GSK Investigational Site
Hokkaido, 005-0841, Japan
GSK Investigational Site
Hokkaido, 006-0811, Japan
GSK Investigational Site
Hokkaido, 040-8611, Japan
GSK Investigational Site
Hokkaido, 060-0033, Japan
GSK Investigational Site
Hokkaido, 060-0061, Japan
GSK Investigational Site
Hokkaido, 062-8618, Japan
GSK Investigational Site
Hokkaido, 064-0801, Japan
GSK Investigational Site
Hokkaido, 080-0024, Japan
GSK Investigational Site
Hyōgo, 650-0047, Japan
GSK Investigational Site
Hyōgo, 664-8540, Japan
GSK Investigational Site
Hyōgo, 672-8064, Japan
GSK Investigational Site
Hyōgo, 675-8611, Japan
GSK Investigational Site
Ibaraki, 305-8576, Japan
GSK Investigational Site
Ibaraki, 310-0015, Japan
GSK Investigational Site
Ibaraki, 311-3193, Japan
GSK Investigational Site
Ibaraki, 317-0077, Japan
GSK Investigational Site
Ibaraki, 319-1113, Japan
GSK Investigational Site
Kagawa, 761-8073, Japan
GSK Investigational Site
Kagawa, 761-8538, Japan
GSK Investigational Site
Kagawa, 762-8550, Japan
GSK Investigational Site
Kanagawa, 210-0822, Japan
GSK Investigational Site
Kanagawa, 224-8503, Japan
GSK Investigational Site
Kanagawa, 231-8682, Japan
GSK Investigational Site
Kanagawa, 232-0066, Japan
GSK Investigational Site
Kanagawa, 236-0004, Japan
GSK Investigational Site
Kanagawa, 252-0392, Japan
GSK Investigational Site
Kyoto, 607-8062, Japan
GSK Investigational Site
Kyoto, 610-0113, Japan
GSK Investigational Site
Kyoto, 612-0026, Japan
GSK Investigational Site
Kyoto, 615-8087, Japan
GSK Investigational Site
Mie, 515-8544, Japan
GSK Investigational Site
Miyagi, 983-0833, Japan
GSK Investigational Site
Miyagi, 983-8520, Japan
GSK Investigational Site
Miyagi, 984-8560, Japan
GSK Investigational Site
Miyagi, 986-8522, Japan
GSK Investigational Site
Miyagi, 989-1253, Japan
GSK Investigational Site
Nagano, 386-8610, Japan
GSK Investigational Site
Nagasaki, 850-0003, Japan
GSK Investigational Site
Nara, 632-8552, Japan
GSK Investigational Site
Okayama, 701-0304, Japan
GSK Investigational Site
Okinawa, 901-2121, Japan
GSK Investigational Site
Okinawa, 901-2214, Japan
GSK Investigational Site
Osaka, 536-0001, Japan
GSK Investigational Site
Osaka, 545-8586, Japan
GSK Investigational Site
Osaka, 550-0006, Japan
GSK Investigational Site
Osaka, 583-8588, Japan
GSK Investigational Site
Osaka, 591-8037, Japan
GSK Investigational Site
Osaka, 591-8555, Japan
GSK Investigational Site
Osaka, 593-8304, Japan
GSK Investigational Site
Osaka, 596-8501, Japan
GSK Investigational Site
Ōita, 874-0011, Japan
GSK Investigational Site
Saga, 843-0393, Japan
GSK Investigational Site
Saitama, 333-0833, Japan
GSK Investigational Site
Saitama, 351-0102, Japan
GSK Investigational Site
Shimane, 690-8556, Japan
GSK Investigational Site
Shizuoka, 421-0193, Japan
GSK Investigational Site
Shizuoka, 438-8550, Japan
GSK Investigational Site
Tokyo, 103-0027, Japan
GSK Investigational Site
Tokyo, 103-0028, Japan
GSK Investigational Site
Tokyo, 104-8560, Japan
GSK Investigational Site
Tokyo, 105-0003, Japan
GSK Investigational Site
Tokyo, 142-8666, Japan
GSK Investigational Site
Tokyo, 145-0063, Japan
GSK Investigational Site
Tokyo, 145-0071, Japan
GSK Investigational Site
Tokyo, 157-0066, Japan
GSK Investigational Site
Tokyo, 158-0097, Japan
GSK Investigational Site
Tokyo, 164-0012, Japan
GSK Investigational Site
Tokyo, 169-0073, Japan
GSK Investigational Site
Tokyo, 171-0014, Japan
GSK Investigational Site
Tokyo, 187-0024, Japan
GSK Investigational Site
Toyama, 937-0042, Japan
GSK Investigational Site
Yamagata, 990-8533, Japan
GSK Investigational Site
Yamagata, 992-0045, Japan
GSK Investigational Site
Yamaguchi, 755-0241, Japan
GSK Investigational Site
Yamanashi, 400-0031, Japan
GSK Investigational Site
Alkmaar, 1815 JD, Netherlands
GSK Investigational Site
Almere Stad, 1311 RL, Netherlands
GSK Investigational Site
Beek, 6191 JW, Netherlands
GSK Investigational Site
Breda, 4818 CK, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Hengelo, 7555 DL, Netherlands
GSK Investigational Site
Leiden, 2333 ZA, Netherlands
GSK Investigational Site
Rotterdam, 3051 GV, Netherlands
GSK Investigational Site
Rotterdam, 3067 GJ, Netherlands
GSK Investigational Site
Rotterdam, 3083 AN, Netherlands
GSK Investigational Site
Utrecht, 3511 NH, Netherlands
GSK Investigational Site
Bialystok, 15-183, Poland
GSK Investigational Site
Bydgoszcz, 85-681, Poland
GSK Investigational Site
Grudziądz, 86-300, Poland
GSK Investigational Site
Kościan, 64-000, Poland
GSK Investigational Site
Krakow, 31-209, Poland
GSK Investigational Site
Krakow, 31-637, Poland
GSK Investigational Site
Lodz, 90-302, Poland
GSK Investigational Site
Lublin, 20-089, Poland
GSK Investigational Site
Ostrowiec Świętokrzyski, 27-400, Poland
GSK Investigational Site
Poznan, 60-823, Poland
GSK Investigational Site
Rzeszów, 35-051, Poland
GSK Investigational Site
Sopot, 81-741, Poland
GSK Investigational Site
Szczecin, 71-124, Poland
GSK Investigational Site
Słupsk, 76-200, Poland
GSK Investigational Site
Tarnów, 33-100, Poland
GSK Investigational Site
Zgierz, 95-100, Poland
GSK Investigational Site
Bacau, 600114, Romania
GSK Investigational Site
Brasov, 500051, Romania
GSK Investigational Site
Brasov, 500091, Romania
GSK Investigational Site
Bucharest, 012363, Romania
GSK Investigational Site
Bucharest, 014452, Romania
GSK Investigational Site
Bucharest, 020125, Romania
GSK Investigational Site
Bucharest, 030317, Romania
GSK Investigational Site
Bucharest, 040069, Romania
GSK Investigational Site
Bucharest, 050159, Romania
GSK Investigational Site
Cluj-Napoca, 400015, Romania
GSK Investigational Site
Cluj-Napoca, 400162, Romania
GSK Investigational Site
Cluj-Napoca, 400371, Romania
GSK Investigational Site
Craiova, 200486, Romania
GSK Investigational Site
Deva, 330084, Romania
GSK Investigational Site
Galati, 800189, Romania
GSK Investigational Site
Iași, 700115, Romania
GSK Investigational Site
Oradea, 410176, Romania
GSK Investigational Site
Piteşti, 110117, Romania
GSK Investigational Site
Slobozia, 920013, Romania
GSK Investigational Site
Suceava, 720284, Romania
GSK Investigational Site
Târgu Mureş, 540156, Romania
GSK Investigational Site
Timișoara, 300134, Romania
GSK Investigational Site
Timișoara, 300310, Romania
GSK Investigational Site
Arkhangelsk, 163000, Russia
GSK Investigational Site
Belgorod, 308007, Russia
GSK Investigational Site
Blagoveshchensk, 675000, Russia
GSK Investigational Site
Chelyabinsk, 454006, Russia
GSK Investigational Site
Chita, 672000, Russia
GSK Investigational Site
Irkutsk, 664043, Russia
GSK Investigational Site
Ivanovo, 153462, Russia
GSK Investigational Site
Izhevsk, 426063, Russia
GSK Investigational Site
Kazan', 420008, Russia
GSK Investigational Site
Kemerovo, 650000, Russia
GSK Investigational Site
Kemerovo, 650002, Russia
GSK Investigational Site
Khantymansiysk, 628012, Russia
GSK Investigational Site
Krasnodar, 350012, Russia
GSK Investigational Site
Krasnoyarsk, 660022, Russia
GSK Investigational Site
Moscow, 115 280, Russia
GSK Investigational Site
Orenburg, 460040, Russia
GSK Investigational Site
Perm, 614109, Russia
GSK Investigational Site
Petrozavodsk, 185019, Russia
GSK Investigational Site
Saint Petersburg, 193231, Russia
GSK Investigational Site
Saint Petersburg, 194354, Russia
GSK Investigational Site
Saint Petersburg, 195030, Russia
GSK Investigational Site
Saint Petersburg, 196240, Russia
GSK Investigational Site
Saint Petersburg, 197022, Russia
GSK Investigational Site
Saint Petersburg, 198328, Russia
GSK Investigational Site
Samara, 443068, Russia
GSK Investigational Site
Saratov, 410028, Russia
GSK Investigational Site
Saratov, 410053, Russia
GSK Investigational Site
Tomsk, 634 050, Russia
GSK Investigational Site
Tomsk, 634028, Russia
GSK Investigational Site
Tver', 170036, Russia
GSK Investigational Site
Ufa, 450071, Russia
GSK Investigational Site
Ulan-Ude, 670031, Russia
GSK Investigational Site
Ulyanovsk, 432063, Russia
GSK Investigational Site
Yaroslavl, 150003, Russia
GSK Investigational Site
Yaroslavl, 150047, Russia
GSK Investigational Site
Yekaterinburg, 620137, Russia
GSK Investigational Site
Middelburg, Mpumalanga, 1055, South Africa
GSK Investigational Site
Bellville, 7530, South Africa
GSK Investigational Site
Bloemfontein, 9301, South Africa
GSK Investigational Site
Cape Town, 7764, South Africa
GSK Investigational Site
Durban, 4001, South Africa
GSK Investigational Site
Mowbray, 7700, South Africa
GSK Investigational Site
Panorama, 7500, South Africa
GSK Investigational Site
Pretoria West, 0183, South Africa
GSK Investigational Site
Reiger Park, 1459, South Africa
GSK Investigational Site
Somerset West, 7130, South Africa
GSK Investigational Site
Tygerberg, 7500, South Africa
GSK Investigational Site
Busan, 602-715, South Korea
GSK Investigational Site
Cheongju-si, Chungcheongbuk-do, 28644, South Korea
GSK Investigational Site
Daegu, 41944, South Korea
GSK Investigational Site
Daegu, 705-703, South Korea
GSK Investigational Site
Daejeon, 35365, South Korea
GSK Investigational Site
Gwangju, 61469, South Korea
GSK Investigational Site
Seoul, 05505, South Korea
GSK Investigational Site
Seoul, 06591, South Korea
GSK Investigational Site
Seoul, 110-744, South Korea
GSK Investigational Site
Seoul, 130-709, South Korea
GSK Investigational Site
Seoul, 140-887, South Korea
GSK Investigational Site
Suwon-si, Gyeonggi-do, 443-380, South Korea
GSK Investigational Site
Wonju-si, Kanwon-do, 220-701, South Korea
GSK Investigational Site
Alcobendas, Madrid, 28100, Spain
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08006, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Burgos, 09006, Spain
GSK Investigational Site
Centelles, 8540, Spain
GSK Investigational Site
Girona, 17005, Spain
GSK Investigational Site
L'Hospitalet de Llobregat, 08907, Spain
GSK Investigational Site
Las Palmas, 35012, Spain
GSK Investigational Site
Loja/ Granada, 18300, Spain
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223, Spain
GSK Investigational Site
Salamanca, 37007, Spain
GSK Investigational Site
Santander, 39008, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Valladolid, 47012, Spain
GSK Investigational Site
Zaragoza, 50009, Spain
GSK Investigational Site
Aberdeen, Aberdeenshire, AB25 2ZG, United Kingdom
GSK Investigational Site
Romford, Essex, RM1 3PJ, United Kingdom
GSK Investigational Site
Wishaw, Lanarkshire, ML2 0DP, United Kingdom
GSK Investigational Site
Blackpool, Lancashire, FY3 7EN, United Kingdom
GSK Investigational Site
Northwood, Middlesex, HA6 2RN, United Kingdom
GSK Investigational Site
Corby, Northamptonshire, NN17 2UR, United Kingdom
GSK Investigational Site
Bexhill-on-Sea, Sussex East, TN40 1JJ, United Kingdom
GSK Investigational Site
Bradford, BD9 6RJ, United Kingdom
GSK Investigational Site
Edgbaston, B15 2GW, United Kingdom
GSK Investigational Site
Liverpool, L7 8XP, United Kingdom
GSK Investigational Site
Sidcup, Kent, DA14 6LT, United Kingdom
GSK Investigational Site
Trowbridge, BA14 9AR, United Kingdom
Related Publications (6)
Oppenheimer J, Pavord ID, Corbridge T, Crawford J, Gould S, Hamouda M, Howarth P, Burrows E, Moore A, Noorduyn SG, Slade D, Weng S, Lugogo N. Evaluating Asthma Clinical Remission with Inhaled Therapy: Post Hoc Analyses of CAPTAIN. Adv Ther. 2025 Dec 24. doi: 10.1007/s12325-025-03442-x. Online ahead of print.
PMID: 41442024DERIVEDOppenheimer J, Hanania NA, Chaudhuri R, Sagara H, Bailes Z, Fowler A, Peachey G, Pizzichini E, Slade D. Clinic vs Home Spirometry for Monitoring Lung Function in Patients With Asthma. Chest. 2023 Nov;164(5):1087-1096. doi: 10.1016/j.chest.2023.06.029. Epub 2023 Jun 27.
PMID: 37385337DERIVEDOba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PMID: 36472162DERIVEDNakamura Y, Hozawa S, Sagara H, Ohbayashi H, Lee LA, Crawford J, Tamaoki J, Nishi T, Fowler A. Efficacy and safety of once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol in Japanese patients with inadequately controlled asthma: the CAPTAIN study. Curr Med Res Opin. 2021 Sep;37(9):1657-1665. doi: 10.1080/03007995.2021.1944849. Epub 2021 Jul 14.
PMID: 34162298DERIVEDYang S, Lee LA, Sule N, Fowler A, Peachey G. Population Pharmacokinetic Modeling of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol in Patients with Asthma, Using Data from a Phase IIIA Study (CAPTAIN). Clin Pharmacokinet. 2021 Jul;60(7):887-896. doi: 10.1007/s40262-021-00988-1. Epub 2021 Feb 18.
PMID: 33598874DERIVEDLee LA, Bailes Z, Barnes N, Boulet LP, Edwards D, Fowler A, Hanania NA, Kerstjens HAM, Kerwin E, Nathan R, Oppenheimer J, Papi A, Pascoe S, Brusselle G, Peachey G, Sule N, Tabberer M, Pavord ID. Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. Lancet Respir Med. 2021 Jan;9(1):69-84. doi: 10.1016/S2213-2600(20)30389-1. Epub 2020 Sep 9.
PMID: 32918892DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2016
First Posted
October 5, 2016
Study Start
October 13, 2016
Primary Completion
February 22, 2019
Study Completion
February 22, 2019
Last Updated
March 26, 2021
Results First Posted
February 21, 2020
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study is available via the Clinical Study Data Request site.