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))

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg; Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg	Phase 3

Detailed Description:

This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligilibilty 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	528 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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)
Study Start Date :	February 2011
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	October 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Fluticasone Furoate/Vilanterol; Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)	Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg; Inhalation Powder
Active Comparator: Fluticasone Propionate/Salmeterol; Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA	Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg; Inhalation Powder

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 [ Time Frame: Baseline and 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 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.

Secondary Outcome Measures :

1. Time to Onset on Treatment Day 1 [ Time Frame: 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, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.
2. Change From Baseline in Trough FEV1 on Treatment Day 85 [ Time Frame: Baseline and Day 85 ]
   Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value.

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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  Show 66 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Individual Participant Data Set 

Identifier: 113107
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 113107
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 113107
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 113107
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 113107
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 113107
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 113107
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Agustí A, de Teresa L, De Backer W, Zvarich MT, Locantore N, Barnes N, Bourbeau J, Crim C. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014 Mar;43(3):763-72. doi: 10.1183/09031936.00054213. Epub 2013 Oct 10.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01342913 History of Changes
Other Study ID Numbers:	113107
First Posted:	April 27, 2011
Results First Posted:	July 30, 2013
Last Update Posted:	March 3, 2017
Last Verified:	January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration; Chronic Disease; Respiratory Tract Diseases; Lung Diseases, Obstructive; Respiration Disorders; Pathologic Processes; Disease Attributes; Fluticasone; Salmeterol Xinafoate; Anti-Inflammatory Agents; Bronchodilator Agents	Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action