Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma.

NCT00600171 | Completed Phase 2 Results

• 1 other identifier: B2C109575
• Study Type: interventional
• Target: 614
• Locations: 16 countries
• Sites: 89

Brief Summary

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma

Conditions

Asthma

Keywords

dose ranging; placebo; asthma; safety; efficacy; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF])

  Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.

  Baseline and Day 28

Secondary Outcomes (9)

• Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF)

  Baseline and Day 28

• Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28

  Baseline; Day 1 and Day 28 (mean post-dose FEV1 after 15, 30, and 60 minutes and 2, 3, 4, 6, 12, 16, 20, 22, 23, and 24 hours)

• Mean Change From Baseline in Trough (Pre-dose and Pre-bronchodilator) Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 28-day Treatment Period

  Baseline and Days 1-28

• Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 28-day Treatment Period

  Baseline and Days 1-28

• Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period

  Baseline and Days 1-28

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Multi dose dry powder inhlaer

Drug: Placebo

GW642444M

EXPERIMENTAL

GW642444M

Drug: GW642444M

Interventions

GW642444M DRUG

GW642444M

GW642444M

Placebo DRUG

Placebo mulit-dose dry powder inhaler

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 12 years of age or older at Visit 1 For sites in the following countries, subjects recruited will be ³ 18 years of age: Germany, Hungary and the Russian Federation and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only.
• Male or eligible female subjects
• A female is eligible to enter and participate in the study if she is of:
• Non-child bearing potential (i.e. physiologically incapable of becoming pregnant), including any female who is post-menopausal.
• Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
• Complete abstinence from intercourse from screening until 2 weeks after the follow-up contact; or
• Sterilisation of male partner (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
• Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
• Injectable progestogen administered for at least 1 month prior to study medication administration and administered for 1 month following study completion; or
• Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
• Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) N.B. For German sites female subjects must use a method of birth control other than the double barrier method
• An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
• Estrogenic vaginal ring inserted for at least 1 month prior to study medication administration; or
• Percutaneous contraceptive patches in place for at least 1 month prior to study medication administration Female subjects should not be enrolled if they are pregnant, or lactating, or plan to become pregnant during the time of study participation.
• Documented clinical history of persistent asthma, as defined by the National Institutes of Health \[NIH, 2007\] first diagnosed at least 6 months prior to Visit 1.

You may not qualify if:

• An exacerbation of asthma within 4 weeks of Visit 1, or a culture documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks of Visit 1 that led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study.
• History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
• Asthma exacerbation requiring treatment with oral corticosteroids within 3 months prior to Visit 1.
• Hospitalised for an asthma exacerbation within 6 months of Visit 1. Hospitalisation is defined as an overnight stay in a hospital.
• Previously enrolled in this study, or has participated in any study using an investigational drug during the previous 30 days or will participate simultaneously in another clinical trial.
• A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the subject's safety at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
• The list of additional excluded conditions/diseases includes, but is not limited to the following:
• congestive heart failure, known aortic aneurysm clinically significant coronary heart disease, clinically significant cardiac arrhythmia stroke within 3 months of Visit 1, uncontrolled hypertension1 poorly controlled peptic ulcer, haematologic, hepatic, or renal disease immunologic compromise, current malignancy2 tuberculosis (current or untreated3), Cushing's disease Addison's disease, uncontrolled diabetes mellitus uncontrolled thyroid disorder, recent history of drug or alcohol abuse neurological disease, pulmonary disease4
• systolic blood pressure 160, or diastolic blood pressure \>100
• history of malignancy is acceptable only if subject has been in remission for one year prior to Visit 1 (remission = no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to Visit 1)
• Subjects with a history of tuberculosis who have received an approved prophylactic treatment regimen or an approved active treatment regimen and who have no evidence of active disease for a minimum of 2 years may be enrolled \[American Thoracic Society Documents, 2005\] \[American Thoracic Society (ATS), 2003\]
• Including but not limited to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease.
• Any adverse reaction including immediate or delayed hypersensitivity to any ß2-agonist or sympathomimetic drug, or known (i.e., patients with a history of severe milk protein allergy) or suspected sensitivity to the constituents of GW642444M inhalation powder (e.g., lactose or magnesium stearate).
• Subjects who are likely to be non-compliant with study medication and other study-related requirements (e.g. attendance at clinic visits or completion of Daily Diary).
• Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol requirements.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (89)

GSK Investigational Site

Phoenix, Arizona, 85006, United States

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GSK Investigational Site

Phoenix, Arizona, 85050, United States

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GSK Investigational Site

Fresno, California, 93720, United States

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GSK Investigational Site

Huntington Beach, California, 92647, United States

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GSK Investigational Site

Long Beach, California, 90806, United States

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GSK Investigational Site

Long Beach, California, 90808, United States

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GSK Investigational Site

Rolling Hills Estates, California, 90274, United States

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GSK Investigational Site

San Diego, California, 92123, United States

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GSK Investigational Site

Denver, Colorado, 80230, United States

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GSK Investigational Site

Tallahassee, Florida, 32308, United States

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GSK Investigational Site

Valrico, Florida, 33596, United States

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GSK Investigational Site

Coeur d'Alene, Idaho, 83814, United States

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GSK Investigational Site

River Forest, Illinois, 60305, United States

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GSK Investigational Site

Metairie, Louisiana, 70006, United States

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GSK Investigational Site

Sunset, Louisiana, 70584, United States

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GSK Investigational Site

Bethesda, Maryland, 20814, United States

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GSK Investigational Site

North Dartmouth, Massachusetts, 02747, United States

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GSK Investigational Site

Columbia, Missouri, 65203, United States

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GSK Investigational Site

Rolla, Missouri, 65401, United States

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GSK Investigational Site

St Louis, Missouri, 63141, United States

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GSK Investigational Site

Skillman, New Jersey, 08558, United States

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GSK Investigational Site

The Bronx, New York, 10461, United States

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GSK Investigational Site

Raleigh, North Carolina, 27607, United States

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GSK Investigational Site

Canton, Ohio, 44718, United States

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GSK Investigational Site

Cincinnati, Ohio, 45231, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73120, United States

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GSK Investigational Site

Medford, Oregon, 97504, United States

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GSK Investigational Site

Providence, Rhode Island, 02909, United States

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GSK Investigational Site

Orangeburg, South Carolina, 29118, United States

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GSK Investigational Site

Knoxville, Tennessee, 37909, United States

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GSK Investigational Site

Buenos Aires, Buenos Aires, 1425, Argentina

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GSK Investigational Site

Buenos Aires, Buenos Aires, 1437, Argentina

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GSK Investigational Site

La Plata, Buenos Aires, CP1900, Argentina

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GSK Investigational Site

Mendoza, Mendoza Province, M5500CCG, Argentina

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GSK Investigational Site

San Miguel de Tucumán, 4000, Argentina

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GSK Investigational Site

Edegem, 2650, Belgium

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GSK Investigational Site

Liège, 4000, Belgium

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GSK Investigational Site

Brampton, Ontario, L6T 3T1, Canada

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GSK Investigational Site

Mississauga, Ontario, L4W 1N2, Canada

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GSK Investigational Site

Mississauga, Ontario, L5A 3V4, Canada

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GSK Investigational Site

Montreal, Quebec, H3H 2R9, Canada

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GSK Investigational Site

Montreal, Quebec, H4W 1S7, Canada

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GSK Investigational Site

Québec, Quebec, G1V 4M6, Canada

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GSK Investigational Site

Sainte-Foy, Quebec, G1V 4G5, Canada

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GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

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GSK Investigational Site

Santiago, Región Metro de Santiago, 7500551, Chile

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GSK Investigational Site

Santiago, 8380453, Chile

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GSK Investigational Site

Montpellier, 34295, France

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GSK Investigational Site

Paris, 75018, France

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GSK Investigational Site

Toulouse, 31059, France

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68161, Germany

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GSK Investigational Site

Wiesloch, Baden-Wurttemberg, 69168, Germany

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GSK Investigational Site

Rüdersdorf, Brandenburg, 15562, Germany

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GSK Investigational Site

Wiesbaden, Hesse, 65187, Germany

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GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

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GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

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GSK Investigational Site

Berlin, State of Berlin, 14057, Germany

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GSK Investigational Site

Harderwijk, 3844 DG, Netherlands

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GSK Investigational Site

Heerlen, 6419 PC, Netherlands

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GSK Investigational Site

Utrecht, 3584 CJ, Netherlands

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GSK Investigational Site

Lima, Lima Province, Lima 1, Peru

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GSK Investigational Site

Lima, Lima Province, Lima 27, Peru

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GSK Investigational Site

Lima, Lima 11, Peru

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GSK Investigational Site

Cavite, 4114, Philippines

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GSK Investigational Site

Manila, 1000, Philippines

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GSK Investigational Site

Bialystok, 15-025, Poland

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GSK Investigational Site

Bydgoszcz, 85-168, Poland

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GSK Investigational Site

Krakow, 31-023, Poland

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GSK Investigational Site

Lodz, 91-348, Poland

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GSK Investigational Site

Lodz, 93-504, Poland

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GSK Investigational Site

Kazan', 420015, Russia

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GSK Investigational Site

Moscow, 115446, Russia

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GSK Investigational Site

Moscow, 117292, Russia

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GSK Investigational Site

Ryazan, 390039, Russia

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GSK Investigational Site

Saint Petersburg, Russia

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GSK Investigational Site

Saratov, 410002, Russia

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GSK Investigational Site

Yaroslavl, 150003, Russia

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GSK Investigational Site

Cape Town, Gauteng, 7505, South Africa

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GSK Investigational Site

Cape Town, 7500, South Africa

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GSK Investigational Site

Claremont, 7708, South Africa

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GSK Investigational Site

eManzimtoti, 4126, South Africa

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GSK Investigational Site

Mowbray, 7700, South Africa

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GSK Investigational Site

Cheongju, Chungcheongbuk-do, 361-711, South Korea

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GSK Investigational Site

Suwon, 443-721, South Korea

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GSK Investigational Site

Gothenburg, SE-413 45, Sweden

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GSK Investigational Site

Lund, SE-221 85, Sweden

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GSK Investigational Site

Chiang Mai, 50200, Thailand

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GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Lotvall J, Bateman ED, Bleecker ER, Busse WW, Woodcock A, Follows R, Lim J, Stone S, Jacques L, Haumann B. 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroids. Eur Respir J. 2012 Sep;40(3):570-9. doi: 10.1183/09031936.00121411. Epub 2012 Feb 23.

  PMID: 22362859 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 16, 2016
• Results First Posted: August 12, 2013

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (3); US (30); BE (2); CA (8); SE (2); FR (3); TH (2); ZA (5); KR (2); AR (5); CL (2); RU (7); PE (3); PL (5); DE (8); PH (2)