- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01323634
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
October 9, 2017 updated by: GlaxoSmithKline
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)
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
519
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Benesov, Czechia, 256 30
- GSK Investigational Site
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Blansko, Czechia, 678 31
- GSK Investigational Site
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Kromeriz, Czechia, 767 55
- GSK Investigational Site
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Kyjov, Czechia, 697 33
- GSK Investigational Site
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Melnik, Czechia, 276 01
- GSK Investigational Site
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Novy Jicin, Czechia, 741 01
- GSK Investigational Site
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Rokycany, Czechia, 337 01
- GSK Investigational Site
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Trebic, Czechia, 674 01
- GSK Investigational Site
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Berlin, Germany, 14057
- GSK Investigational Site
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Berlin, Germany, 10717
- GSK Investigational Site
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Berlin, Germany, 10787
- GSK Investigational Site
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Hessen
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Frankfurt, Hessen, Germany, 60596
- GSK Investigational Site
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Frankfurt am Main, Hessen, Germany, 60596
- GSK Investigational Site
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Wiesbaden, Hessen, Germany, 65183
- GSK Investigational Site
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Mecklenburg-Vorpommern
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Schwerin, Mecklenburg-Vorpommern, Germany, 19055
- GSK Investigational Site
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Dzialdowo, Poland, 13-200
- GSK Investigational Site
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Elblag, Poland, 82-300
- GSK Investigational Site
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Inowrocław, Poland, 88-100
- GSK Investigational Site
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Katowice, Poland, 40-018
- GSK Investigational Site
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Krakow, Poland, 31-159
- GSK Investigational Site
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Poznan, Poland, 60-214
- GSK Investigational Site
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Wroclaw, Poland, 54-239
- GSK Investigational Site
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Brasov, Romania, 500283
- GSK Investigational Site
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Brasov, Romania, 500112
- GSK Investigational Site
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Bucharest, Romania, 050159
- GSK Investigational Site
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Bucharest, Romania, 011794
- GSK Investigational Site
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Bucharest, Romania, 030317
- GSK Investigational Site
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Bucuresti, Romania, 70000
- GSK Investigational Site
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Cluj Napoca, Romania, 400371
- GSK Investigational Site
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Iasi, Romania, 700115
- GSK Investigational Site
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Suceava, Romania, 720284
- GSK Investigational Site
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Timisoara, Romania, 300310
- GSK Investigational Site
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Barnaul, Russian Federation, 656024
- GSK Investigational Site
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Barnaul, Russian Federation, 656038
- GSK Investigational Site
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Kaluga, Russian Federation, 248007
- GSK Investigational Site
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Kemerovo, Russian Federation, 650002
- GSK Investigational Site
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Kursk, Russian Federation, 305035
- GSK Investigational Site
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Moscow, Russian Federation, 125367
- GSK Investigational Site
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St. Petersburg, Russian Federation, 194291
- GSK Investigational Site
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California
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Los Angeles, California, United States, 90048
- GSK Investigational Site
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Florida
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Orlando, Florida, United States, 32822
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30342
- GSK Investigational Site
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Kentucky
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Madisonville, Kentucky, United States, 42431
- GSK Investigational Site
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Missouri
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Saint Louis, Missouri, United States, 63141
- GSK Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28207
- GSK Investigational Site
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Raleigh, North Carolina, United States, 27607
- GSK Investigational Site
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Ohio
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Columbus, Ohio, United States, 43215
- GSK Investigational Site
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South Carolina
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Easley, South Carolina, United States, 29640
- GSK Investigational Site
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Greenville, South Carolina, United States, 29615
- GSK Investigational Site
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Union, South Carolina, United States, 29379
- GSK Investigational Site
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Texas
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Waco, Texas, United States, 76712
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Fluticasone Furoate / GW642444 (vilanterol)
Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
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inhalation powder
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Active Comparator: Fluticasone Propionate / salmeterol
Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
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inhalation powder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
Time Frame: Baseline (Day 1) and Day 84
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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.
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Baseline (Day 1) and Day 84
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Onset on Treatment Day 1
Time Frame: Day 1
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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.
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2011
Primary Completion (Actual)
December 14, 2011
Study Completion (Actual)
December 14, 2011
Study Registration Dates
First Submitted
March 17, 2011
First Submitted That Met QC Criteria
March 24, 2011
First Posted (Estimate)
March 25, 2011
Study Record Updates
Last Update Posted (Actual)
November 8, 2017
Last Update Submitted That Met QC Criteria
October 9, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Respiratory Aspiration
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Fluticasone
- Xhance
- Salmeterol Xinafoate
Other Study ID Numbers
- 113109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
Study Data/Documents
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Study Protocol
Information identifier: 113109Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 113109Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 113109Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 113109Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 113109Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 113109Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 113109Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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