Asthma Exacerbation Study

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

NCT01086384

106837

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

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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