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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323634
First received: March 17, 2011
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg
Drug: Fluticasone Propionate 250mcg/ salmeterol 50mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 [ Time Frame: Baseline (Day 1) and Day 84 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to Onset on Treatment Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 521
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone Furoate / GW642444 (vilanterol)
Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
Drug: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg
inhalation powder
Active Comparator: Fluticasone Propionate / salmeterol
Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
Drug: Fluticasone Propionate 250mcg/ salmeterol 50mcg
inhalation powder

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323634

  Show 52 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323634     History of Changes
Other Study ID Numbers: 113109
Study First Received: March 17, 2011
Results First Received: May 30, 2013
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Fluticasone
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014