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)

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: NCT01323621
• Other study ID #: 112352
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2011
• Last updated: January 18, 2018
• Start date: March 18, 2011
• Est. completion date: January 24, 2012

Study information

• Verified date: January 2018
• 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: 512
• Est. completion date: January 24, 2012
• Est. primary completion date: January 1, 2012
• 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
• Double-dummy placebo
inhalation powder
• Salbutamol as needed
inhalation powder

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Italy	GSK Investigational Site	Cagliari	Sardegna
Italy	GSK Investigational Site	Firenze	Toscana
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Rozzano (MI)	Lombardia
Italy	GSK Investigational Site	San Felice A Cancello Caserta	Campania
Italy	GSK Investigational Site	Telese Terme (BN)	Campania
Italy	GSK Investigational Site	Torrette (AN)	Marche
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Benoni	Gauteng
South Africa	GSK Investigational Site	Bloemfontein
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	George
South Africa	GSK Investigational Site	Port Elizabeth
South Africa	GSK Investigational Site	Reiger Park
South Africa	GSK Investigational Site	Somerset West
South Africa	GSK Investigational Site	Thabazimbi
South Africa	GSK Investigational Site	Witbank
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Córdoba
Spain	GSK Investigational Site	Lugo
Spain	GSK Investigational Site	Mérida (Badajoz)
Spain	GSK Investigational Site	Ponferrada (León)
Spain	GSK Investigational Site	Valladolid
Ukraine	GSK Investigational Site	Cherkassy
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Mykolayiv
Ukraine	GSK Investigational Site	Vinnytsia
United States	GSK Investigational Site	Boerne	Texas
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Coeur d'Alene	Idaho
United States	GSK Investigational Site	DeLand	Florida
United States	GSK Investigational Site	Gaffney	South Carolina
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Seneca	South Carolina
United States	GSK Investigational Site	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Germany,  Italy,  South Africa,  Spain,  Ukraine, 

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), defined as the maximal amount of air that can be forcefully exhaled in one second. 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 post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as 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. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.	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 to onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.	Baseline and Day 1

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