Last updated: 11/07/2018 04:46:34
Study Evaluating 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 (COPD)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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: Baseline and Day 1
Interventions:
Drug: Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg
Drug: Fluticasone Propionate 250mcg / salmeterol 50mcg
Drug: Double-dummy placebo
Drug: Salbutamol as needed
Enrollment:
512
Observational study model:
Not applicable
Primary completion date:
2012-24-01
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 January 2012
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
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Telese Terme (BN), Campania, Italy, 82037
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
San Felice a Cancello Caserta, Campania, Italy, 81027
Status
Study Complete
Location
GSK Investigational Site
Seneca, South Carolina, United States, 29678
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
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
Completed
Actual primary completion date
2012-24-01
Actual study completion date
2012-24-01
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.
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