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A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD (DB2113361)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01313637
First received: March 10, 2011
Last updated: April 11, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: 125/25mcg
Drug: 125mcg
Drug: 25mcg
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pre-dose, trough forced vital capacity in one second (FEV1) [ Time Frame: Treatment Day 169 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transition Dyspnea Index (TDI) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Interviewer-administered assessment of patient dyspnea

  • Weighted mean FEV1 over 0 to 6 hours post-dose [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Mean evaluaton of FEV1 assessments obtained over the first 6 hours post-dose

  • Shortness of breath with daily activities (SOBDA) score [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Daily patient completed assessment of dyspnea


Enrollment: 1492
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK573719/GW642444
125/25mcg
 Drug: 125/25mcg
GSK573719/GW642444
Other Name: GSK573719/vilanterol trifenatate
Experimental: GSK573719
125mcg
 Drug: 125mcg
GSK573719
Other Name: GSK573719
Experimental: GW642444
25mcg
 Drug: 25mcg
GW642444
Other Name: vilanterol trifenatate
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo
Other Name: placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of COPD
  • 10 pack-year or greater history of cigarette smoking
  • Post-bronchodilator FEV1/FVC of <0.7
  • Predicted FEV1 of 70% of normal or less
  • Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

Exclusion Criteria:

  • Women who are pregnant, lactating, or planning to become pregnant
  • Respiratory disorders other than COPD, including a current diagnosis of asthma
  • Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled
  • Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device
  • Hospitalization for COPD or pneumonia within 12 weeks prior to screening
  • Lung volume reduction surgery within 12 weeks prior to screening
  • Abnormal and clinically significant ECG findings at screening
  • Clinically significant laboratory findings at screening
  • Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
  • Use of long-term oxygen therapy (12 hours or greater per day)
  • Regular use of nebulized treatment with short-acting bronchodilators
  • Participation in the acute phase of a pulmonary rehabilitation program
  • A know or suspected history of alcohol or drug abuse
  • Affiliation with the investigational site
  • Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW642444
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313637

Locations
France
GSK Investigational Site
Vieux Condé, France, 59690
Ukraine
GSK Investigational Site
Donetsk, Ukraine, 83099
GSK Investigational Site
Ivano-Frankivsk, Ukraine, 76018
GSK Investigational Site
Kharkiv, Ukraine, 61124
GSK Investigational Site
Kiev, Ukraine, 03680
GSK Investigational Site
Kyiv, Ukraine, 03680
GSK Investigational Site
Zaporizhia, Ukraine, 69035
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01313637     History of Changes
Other Study ID Numbers: 113361, 2010-023348-33
Study First Received: March 10, 2011
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
anticholinergic
long-acting beta agonist

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013