Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
KALOS
A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma
3 other identifiers
interventional
2,274
21 countries
360
Brief Summary
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care
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 Dec 2020
Longer than P75 for phase_3 asthma
360 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
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2025
CompletedApril 20, 2025
April 1, 2025
4.3 years
October 26, 2020
April 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
24 Weeks
Rate of severe asthma exacerbations
Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations
Up to 52 weeks
Secondary Outcomes (11)
Change from baseline in morning pre-dose trough FEV1 at Week 24
24 Weeks
Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24
24 weeks
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24
24 Weeks
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (≥0.5 increase equals response) at Week 24
24 weeks
Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24
24 Weeks
- +6 more secondary outcomes
Study Arms (4)
Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg
EXPERIMENTALBGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
BGF MDI 320/14.4/9.6 μg
EXPERIMENTALBGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
ACTIVE COMPARATORBFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)
Symbicort®
ACTIVE COMPARATORBudesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg
Interventions
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Budesonide and formoterol fumarate metered dose inhaler
Budesonide/formoterol fumarate pressurized metered dose inhaler
Eligibility Criteria
You may qualify if:
- to 80 years of age, male and female, BMI \<40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
- Documented history of physician-diagnosed asthma \> and/or = 1 year prior to V1.
- Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
- ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
- FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)
- Participants ≥ 18 years of age: \< 80%
- Participants 12 to \<18 years of age: \< 90%
- FEV1 post-albuterol at V2 or V3 (if repeat needed).
- Participants \> and/or = 18 years of age: Increase \> and/or = 12% and \> and/or = 200 mL.
- Participants 12 to \<18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.
- Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization.
- Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
- Demonstrate acceptable MDI/pMDI administration technique.
- Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
- eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
- +1 more criteria
You may not qualify if:
- \. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.
- a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.
- b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration.
- \. Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
- \. Current evidence of Chronic Obstructive Pulmonary Disease (COPD).
- a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.
- b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.
- c. Depot corticosteroid use for any reason within 3 months of V1.
- \. Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1.
- \. Use of oral beta2-agonist within 3 months of V1.
- \. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.
- \. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.
- \. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
- \. Hospitalization for asthma within 2 months of Visit 1.
- \. Known history of drug or alcohol abuse within 12 months of Visit 1.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (360)
Research Site
Saraland, Alabama, 36571, United States
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Phoenix, Arizona, 85018, United States
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Phoenix, Arizona, 85027, United States
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Sun City West, Arizona, 85375, United States
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Tucson, Arizona, 85715, United States
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Tucson, Arizona, 85745, United States
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Little Rock, Arkansas, 72209, United States
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Covina, California, 91723, United States
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Encinitas, California, 92024, United States
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Fresno, California, 93701, United States
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Laguna Hills, California, 92653, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90027, United States
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Mission Hills, California, 91345, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91324, United States
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San Diego, California, 92119, United States
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Stockton, California, 95207, United States
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Thousand Oaks, California, 91360, United States
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Upland, California, 91786, United States
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Westminster, California, 92683, United States
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Colorado Springs, Colorado, 80923, United States
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Lakewood, Colorado, 80228, United States
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Brandon, Florida, 33511, United States
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Miami, Florida, 33175, United States
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Tampa, Florida, 33607, United States
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Adairsville, Georgia, 30103, United States
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Atlanta, Georgia, 30344, United States
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Columbus, Georgia, 31904, United States
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Lawrenceville, Georgia, 30046, United States
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Rincon, Georgia, 31326, United States
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Savannah, Georgia, 31406, United States
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Tyrone, Georgia, 30290, United States
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Chicago, Illinois, 60657, United States
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River Forest, Illinois, 60305, United States
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Brownsburg, Indiana, 46112, United States
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Indianapolis, Indiana, 46202, United States
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Louisville, Kentucky, 40217, United States
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Crowley, Louisiana, 70526, United States
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Lafayette, Louisiana, 70508, United States
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Lake Charles, Louisiana, 70601, United States
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Bangor, Maine, 04401, United States
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Potomac, Maryland, 20854, United States
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Waldorf, Maryland, 20601, United States
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Boston, Massachusetts, 02115, United States
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Hannibal, Missouri, 63401, United States
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St Louis, Missouri, 63141, United States
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Missoula, Montana, 59808, United States
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Bellevue, Nebraska, 68123, United States
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Lincoln, Nebraska, 68510, United States
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Las Vegas, Nevada, 89106, United States
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Toms River, New Jersey, 08755, United States
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Albuquerque, New Mexico, 87108, United States
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New Hyde Park, New York, 11042, United States
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New Windsor, New York, 12553, United States
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New York, New York, 10016, United States
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The Bronx, New York, 10455, United States
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Charlotte, North Carolina, 28277, United States
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Denver, North Carolina, 28037, United States
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Gastonia, North Carolina, 28054, United States
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Raleigh, North Carolina, 27607, United States
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Fargo, North Dakota, 58104, United States
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Cincinnati, Ohio, 45229, United States
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Cincinnati, Ohio, 45231, United States
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Maumee, Ohio, 43537, United States
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Toledo, Ohio, 43617, United States
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Edmond, Oklahoma, 73034, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74133, United States
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Grants Pass, Oregon, 97527, United States
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DuBois, Pennsylvania, 15801, United States
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Pittsburgh, Pennsylvania, 15236, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Scottdale, Pennsylvania, 15683, United States
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Smithfield, Pennsylvania, 15478, United States
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East Providence, Rhode Island, 02914, United States
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Anderson, South Carolina, 29621, United States
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Greenville, South Carolina, 29607, United States
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North Charleston, South Carolina, 29406, United States
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Franklin, Tennessee, 37067, United States
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Amarillo, Texas, 79106, United States
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Austin, Texas, 78759, United States
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Boerne, Texas, 78006, United States
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Cypress, Texas, 77429, United States
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Dallas, Texas, 75231, United States
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El Paso, Texas, 79912, United States
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Harlingen, Texas, 78550, United States
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Houston, Texas, 77021, United States
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Houston, Texas, 77030, United States
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Kerrville, Texas, 78028, United States
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Lampasas, Texas, 76550, United States
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Nederland, Texas, 77627, United States
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Pearland, Texas, 77584, United States
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Red Oak, Texas, 75154, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Spring, Texas, 77386, United States
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Tomball, Texas, 77375, United States
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Ogden, Utah, 84404, United States
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West Valley City, Utah, 84120, United States
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Colchester, Vermont, 05446, United States
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Manassas, Virginia, 20110, United States
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Kingwood, West Virginia, 26537, United States
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Morgantown, West Virginia, 26505, United States
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Cudahy, Wisconsin, 53110, United States
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Buenos Aires, C1121ABE, Argentina
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Buenos Aires, C1414AIF, Argentina
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CABA, 1056, Argentina
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CABA, C1280AEB, Argentina
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CABA, C1425BEN, Argentina
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Ciudad de Buenos Aires, 1425, Argentina
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Córdoba, X5003DCE, Argentina
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Florida, B1602DQD, Argentina
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Mar del Plata, 7600, Argentina
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Mendoza, M5500GIP, Argentina
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Ranelagh, 1886, Argentina
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Rosario, 2000, Argentina
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Rosario, S2000DEJ, Argentina
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San Fernando, B1646EBJ, Argentina
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Liège, 4000, Belgium
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Namur, 5101, Belgium
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Dupnitsa, 2600, Bulgaria
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Dupnitsa, 2602, Bulgaria
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Haskovo, 6305, Bulgaria
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Kozloduy, 3320, Bulgaria
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Lovech, 5500, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Petrich, 2850, Bulgaria
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Pleven, 5800, Bulgaria
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Rousse, 7000, Bulgaria
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Rousse, 7002, Bulgaria
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Sevlievo, 5403, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 3700, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1421, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9000, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Vidin, 3700, Bulgaria
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Vratsa, 3000, Bulgaria
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Edmonton, Alberta, T5A 4L8, Canada
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Sherwood Park, Alberta, T8H 2M7, Canada
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Kelowna, British Columbia, V1Y 4N7, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Winnipeg, Manitoba, R2V 4W3, Canada
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Winnipeg, Manitoba, R3L 1Z5, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Hamilton, Ontario, L8S 1G5, Canada
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London, Ontario, N6A 1V2, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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Niagara Falls, Ontario, L2H 1H5, Canada
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Toronto, Ontario, M5G 1E2, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1V 4W2, Canada
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Québec, Quebec, G2J 0C4, Canada
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Curicó, 3341643, Chile
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Quillota, 2260000, Chile
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Santiago, 7500571, Chile
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Santiago, 7500657, Chile
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Santiago, 7500698, Chile
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Santiago, 8207257, Chile
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Talca, 3481349, Chile
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Balassagyarmat, 2660, Hungary
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Budapest, 1204, Hungary
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Edelény, 3780, Hungary
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Encs, 3860, Hungary
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Gödöllő, 2100, Hungary
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Hajdúnánás, 4080, Hungary
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Komárom, 2900, Hungary
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Pécs, 7635, Hungary
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Szeged, 6722, Hungary
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Szeged, 7620, Hungary
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Szigetvár, 7900, Hungary
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Ahmedabad, 382415, India
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Aligarh, 202002, India
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Belagavi, 590010, India
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Coimbatore, 641028, India
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Dehradun, 248001, India
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Gūrgaon, 122001, India
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Jaipur, 302039, India
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Mohali, 160062, India
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Nagpur, 440012, India
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New Delhi, 110029, India
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New Delhi, 110060, India
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New Delhi, 110075, India
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Thane, 401107, India
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Visakhapatnam, 530002, India
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Bari, 70124, Italy
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Casatenovo, 23880, Italy
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Cona, 44124, Italy
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Monserrato, 09042, Italy
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Napoli, 80131, Italy
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Pisa, 56100, Italy
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Roma, 00133, Italy
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Roma, 00168, Italy
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Chino-shi, 391-0011, Japan
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Chūōku, 103-0022, Japan
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Chūōku, 103-0027, Japan
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Chūōku, 104-0031, Japan
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Fukui-shi, 910-8526, Japan
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Fukuoka, 811-1394, Japan
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Fukuoka, 819-8555, Japan
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Habikino-shi, 583-8588, Japan
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Hamamatsu, 431-3192, Japan
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Higashiibaraki-gun, 311-3117, Japan
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Himeji-shi, 672-8064, Japan
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Hiroshima-shi, Naka-ku, 730-0853, Japan
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Hitachi-Naka, 312-0057, Japan
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Ikoma-shi, 630-0293, Japan
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Kishiwada-shi, 596-8501, Japan
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Kitakyushu, 802-0052, Japan
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Kiyose-shi, 204-8585, Japan
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Kokubunji-shi, 185-0014, Japan
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Kyoto, 601-8213, Japan
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Kyoto, 612-8555, Japan
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Meguro-ku, 153-0051, Japan
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Nagoya, 457-0866, Japan
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Nankoku-shi, 783-8509, Japan
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Obihiro, 080-0017, Japan
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Omuta-shi, 837-0911, Japan
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Osaka, 530-0001, Japan
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Osaka, 531-0073, Japan
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Osaka, 551-0032, Japan
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Ōita, 870-8511, Japan
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Saga, 849-0917, Japan
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Sakaide-shi, 762-8550, Japan
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Sapporo, 064-0804, Japan
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Setagaya-ku, 157-0072, Japan
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Setagaya-ku, 158-0097, Japan
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Shibuya-ku, 150-0013, Japan
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Shimotsuga-gun, 321-0293, Japan
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Shinagawa-ku, 140-0001, Japan
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Shinagawa-ku, 140-8522, Japan
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Shinjuku-ku, 160-0004, Japan
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Shinjuku-ku, 160-8582, Japan
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Takarazuka-shi, 665-0827, Japan
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Tanabe-shi, 646-8558, Japan
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Toon-shi, 791-0281, Japan
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Toshima-ku, 170-0002, Japan
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Toshima-ku, 170-0003, Japan
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Toshima-ku, 171-0014, Japan
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Tsuchiura-shi, 300-8585, Japan
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Utsunomiya, 329-1193, Japan
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Yanagawa-shi, 832-0059, Japan
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Yokohama, 223-0059, Japan
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Yokohama, 231-8682, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 240-8555, Japan
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Auckland, 0626, New Zealand
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Grafton, 1010, New Zealand
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Nawton, 3200, New Zealand
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Nelson, 7011, New Zealand
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Rotorua, 3040, New Zealand
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Wellington, 6021, New Zealand
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Lima, 15036, Peru
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Lima, 15046, Peru
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Lima, 15088, Peru
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Lima, 15131, Peru
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Lima, LIMA 21, Peru
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Lima, LIMA 31, Peru
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Piura, 20001, Peru
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Baguio City, 2600, Philippines
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Davao City, PH-8000, Philippines
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Iloilo City, 5000, Philippines
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Las Piñas, 1742, Philippines
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Lipa City, 4217, Philippines
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Los Baños, 4030, Philippines
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Manila, 1000, Philippines
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Manila, 1014, Philippines
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Marilao, 3019, Philippines
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Quezon City, 1101, Philippines
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Quezon City, Philippines
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Bialystok, 15-044, Poland
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Bialystok, 15-430, Poland
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Bydgoszcz, 85-079, Poland
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Częstochowa, 42-200, Poland
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Karczew, 05-480, Poland
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Katowice, 40-648, Poland
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Kielce, 25-734, Poland
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Krakow, 30-727, Poland
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Krakow, 31-011, Poland
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Krakow, 31-141, Poland
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Piaseczno, 05-500, Poland
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Poznan, 60-214, Poland
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Poznan, 60-693, Poland
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Poznan, 61-578, Poland
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Rzeszów, 35-051, Poland
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Rzeszów, 35-055, Poland
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Rzeszów, 35-205, Poland
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Sosnowiec, 41-200, Poland
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Sosnowiec, 41-208, Poland
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Strzelce Opolskie, 47-100, Poland
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Szczecin, 70-111, Poland
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Tarnów, 33-100, Poland
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Wroclaw, 53-301, Poland
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Wroclaw, 54-239, Poland
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Caguas, 00726, Puerto Rico
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Guaynabo, 00968, Puerto Rico
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San Juan, 00918, Puerto Rico
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Brasov, 500051, Romania
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Brasov, 500283, Romania
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Brasov, 500366, Romania
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Bucharest, 050159, Romania
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Timișoara, 300002, Romania
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Cheongju-si, 28644, South Korea
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Gangwon-do, 26426, South Korea
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Jeonju, 54907, South Korea
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Seoul, 03312, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Suwon, 16499, South Korea
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Uijeongbu-si, 11765, South Korea
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Ulsan, 44033, South Korea
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Barcelona, 08017, Spain
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Benalmádena, 29631, Spain
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Coslada, 28822, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Madrid, 28007, Spain
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Madrid, 28031, Spain
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Marbella (Málaga), 29603, Spain
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Málaga, 29010, Spain
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Pozuelo de Alarcón, 28223, Spain
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Santander, 39008, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Zaragoza, 50015, Spain
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Changhua, 50006, Taiwan
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 833, Taiwan
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New Taipei City, 23561, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 110, Taiwan
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Taoyuan District, Taiwan
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Bang Kra So, 11000, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chanthaburi, 22000, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 55000, Thailand
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Mueang, 20000, Thailand
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Hanoi, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Hochiminh, 700000, Vietnam
Related Publications (1)
Oba 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: 36472162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
October 30, 2020
Study Start
December 15, 2020
Primary Completion
March 21, 2025
Study Completion
March 21, 2025
Last Updated
April 20, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure