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Asthma Exacerbation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01086384
First received: March 11, 2010
Last updated: May 2, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.


Condition Intervention Phase
Asthma
 Drug: Fluticasone Furoate/GW642444
Drug: Fluticasone furoate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of participants with 1 or more severe asthma exacerbations at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.


Secondary Outcome Measures:
  • Number of severe asthma exacerbations [ Time Frame: Baseline to Follow-up (up to 76 weeks of treatment) ] [ Designated as safety issue: No ]
    A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.

  • Change from Baseline in evening pre-dose trough FEV1 at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.


Enrollment: 2017
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone furoate/GW642444 Drug: Fluticasone Furoate/GW642444
Combination inhaled corticosteroid and long-acting beta2-agonist
Experimental: fluticasone furoate Drug: Fluticasone furoate
Inhaled corticosteroid

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of asthma
  • Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
  • FEV1 of fifty to ninety percent of predicted
  • Currently using inhaled corticosteroid therapy
  • History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year

Exclusion Criteria:

  • History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
  • Respiratory infection or oral candidiasis
  • - Uncontrolled disease or clinical abnormality
  • Allergies
  • Taking another investigational medication or prohibited medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086384

Locations
Argentina
GSK Investigational Site
Parana, Entre Ríos, Argentina, E3100BHK
GSK Investigational Site
Buenos Aires, Argentina, C1425BEN
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
GSK Investigational Site
Mendoza, Argentina, M5500CCG
Japan
GSK Investigational Site
Fukuoka, Japan, 832-0059
GSK Investigational Site
Hokkaido, Japan, 064-0801
Philippines
GSK Investigational Site
Lipa City, Philippines, 4217
Romania
GSK Investigational Site
Bucharest, Romania, 050159
GSK Investigational Site
Bucharest, Romania, 020674
GSK Investigational Site
Craiova, Romania, 200341
GSK Investigational Site
Deva, Romania, 330084
GSK Investigational Site
Pitesti, Romania, 110084
GSK Investigational Site
Sibiu, Romania, 550166
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01086384     History of Changes
Other Study ID Numbers: 106837
Study First Received: March 11, 2010
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013