Last updated: 11/07/2018 05:40:25
Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared with Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects with Chronic Obstructive Pulmonary Disease
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg once daily Compared with Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg twice daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline Trough in 24-hour weighted-mean FEV1 on Treatment Day 84
Timeframe: Baseline (Day 1) and Day 84
Secondary outcomes:
Time to onset on Treatment Day 1
Timeframe: Day 1
Interventions:
Enrollment:
519
Primary completion date:
2011-14-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Dransfield MT, Feldman G, Korenblat P, LaForce C, Locantore N, Pistolesi M, Watkins ML, Crim C, Martinez FJ.Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25mcg) vs twice-daily fluticasone propionate/salmeterol (250/50mcg) in COPD patients.Respir Med.2014;108(8):1171-1179
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
March 2011 to December 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Signed and dated written informed consent
- Male or females ≥ 40 years of age
- Current diagnosis of asthma
- Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
Inclusion and exclusion criteria
Inclusion criteria:
- Signed and dated written informed consent
- Male or females ≥ 40 years of age
- Established clinical history of COPD by ATS/ERS definition
- Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
- Former or current smoker > 10 pack years
- Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)
Exclusion criteria:
- Current diagnosis of asthma
- Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- Lung volume reduction surgery within previous 12 months
- Clinically significant abnormalities not due to COPD by chest x-ray
- Hospitalized for poorly controlled COPD within 12 weeks of Screening
- Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
- Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
- Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities
- Carcinoma not in complete remission for at least 5 years
- Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)
- Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject’s participation
- Known/suspected history of alcohol or drug abuse in the last 2 years
- Women who are pregnant or lactating or plan to become pregnant
- Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit
- Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
- Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day
- Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study
- Non-compliance or inability to comply with study procedures or scheduled visits
- Affiliation with investigator site
Trial location(s)
Location
GSK Investigational Site
Orlando, Florida, United States, 32822
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60596
Status
Study Complete
Showing 1 - 6 of 48 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2011-14-12
Actual study completion date
2011-14-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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