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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323634
• Other study ID #: 113109
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2011
• Last updated: October 9, 2017
• Start date: March 18, 2011
• Est. completion date: December 14, 2011

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be a 7-day Follow-up period after the treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• Est. completion date: December 14, 2011
• Est. primary completion date: December 14, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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, a1-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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Drug:
• Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg
inhalation powder
• Fluticasone Propionate 250mcg/ salmeterol 50mcg
inhalation powder

Locations

Country	Name	City	State
Czechia	GSK Investigational Site	Benesov
Czechia	GSK Investigational Site	Blansko
Czechia	GSK Investigational Site	Kromeriz
Czechia	GSK Investigational Site	Kyjov
Czechia	GSK Investigational Site	Melnik
Czechia	GSK Investigational Site	Novy Jicin
Czechia	GSK Investigational Site	Rokycany
Czechia	GSK Investigational Site	Trebic
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt am Main	Hessen
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Wiesbaden	Hessen
Poland	GSK Investigational Site	Dzialdowo
Poland	GSK Investigational Site	Elblag
Poland	GSK Investigational Site	Inowroclaw
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Wroclaw
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucuresti
Romania	GSK Investigational Site	Cluj Napoca
Romania	GSK Investigational Site	Iasi
Romania	GSK Investigational Site	Suceava
Romania	GSK Investigational Site	Timisoara
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Kaluga
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Kursk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St. Petersburg
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Easley	South Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madisonville	Kentucky
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Union	South Carolina
United States	GSK Investigational Site	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  Poland,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84	Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.	Baseline (Day 1) and Day 84
Secondary	Time to Onset on Treatment Day 1	Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 30 min, 60 min, 120 min, and 240 min) post-dose.	Day 1

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