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Asthma Exacerbation Study

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Asthma

Treatments

Drug: Fluticasone Furoate/GW642444
Drug: Fluticasone furoate

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

2,020 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

2,020 participants in 2 patient groups

Fluticasone furoate/GW642444
Experimental group
Treatment:
Drug: Fluticasone Furoate/GW642444
fluticasone furoate
Experimental group
Treatment:
Drug: Fluticasone furoate

Trial contacts and locations

183

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Data sourced from clinicaltrials.gov

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