Last updated: 11/07/2018 05:39:30
A study to evaluate the 24 hour spirometric effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) compared with Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))
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 of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) once daily compared with Salmeterol/Fluticasone Propionate (FP) Inhalation Powder 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 Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen 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 and Day 84
Secondary outcomes:
Time to onset on Treatment Day 1
Timeframe: Day 1
Change from Baseline in Trough FEV1 on Treatment Day 85
Timeframe: Baseline and Day 85
Interventions:
Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg
Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Enrollment:
528
Observational study model:
Not applicable
Primary completion date:
2011-19-10
Time perspective:
Not applicable
Clinical publications:
Agusti A, de Teresa L, De Backer W, Zvarich M, Locantore N, Barnes N, Bourbeau J, Crim C.A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with fluticasone propionate/salmeterol in COPD patients.Eur Respir J.2014;43(3):763-72
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)
February 2011 to October 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) -have been hospitalised or have been treated with oral corticosteroids or antibiotics for their COPD within the last 3 years prior to Screening (Visit 1)
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
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
Status
Study Complete
Location
GSK Investigational Site
Acquaviva Delle Fonti BA, Puglia, Italy, 70021
Status
Study Complete
Location
GSK Investigational Site
Sesto S. Giovanni MI, Lombardia, Italy, 20099
Status
Study Complete
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60596
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
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
2011-19-10
Actual study completion date
2011-19-10
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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