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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

March 11, 2010
May 2, 2013
February 2010
September 2011   (final data collection date for primary outcome measure)
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.
Time to first severe asthma exacerbation [ Time Frame: Over the 76 week treatment period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01086384 on ClinicalTrials.gov Archive Site
  • 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.
  • Rate of severe asthma exacerbations [ Time Frame: Over the 76 week treatment period ] [ Designated as safety issue: No ]
  • Evening pre-dose trough FEV1 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Asthma Exacerbation Study
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: Fluticasone Furoate/GW642444
    Combination inhaled corticosteroid and long-acting beta2-agonist
  • Drug: Fluticasone furoate
    Inhaled corticosteroid
  • Experimental: Fluticasone furoate/GW642444
    Intervention: Drug: Fluticasone Furoate/GW642444
  • Experimental: fluticasone furoate
    Intervention: Drug: Fluticasone furoate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2017
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Japan,   Philippines,   Romania
 
NCT01086384
106837
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP