Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma (ILA115938)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: FF/GSK573719; Drug: FF/VI; Drug: FF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01573624

115938

Details and patient eligibility

About

Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.

Enrollment: 421 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient
• 18 years of age or older at Visit 1
• Diagnosis of Asthma
• Male or eligible Female
• Pre-bronchodilator FEV1 of 40-80% of the predicted normal value at Visit 1
• Demonstrated reversibility by ≥12% and ≥200mL of FEV1 within 40 minutes following albuterol at Visit 1
• A need for regular controller therapy (i.e., inhaled corticosteroids alone or in combination with a long-acting beta-agonist, or leukotriene modifier etc.,) for a minimum of 8 weeks prior to Visit 1.

Exclusion criteria

• History of Life threatening asthma
• Respiratory infection not resolved
• Asthma exacerbation
• Concurrent respiratory disease
• Current Smokers
• Other diseases that are uncontrolled disease or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study
• A positive Hepatitis B surface antigen or positive Hepatitis C antibody and/or HIV
• Visual clinical evidence of oropharyngeal candidiasis
• Drug or milk protein allergies
• Concomitant medications affecting course of asthma
• Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
• Previous use of GSK573719
• Any disease preventing use of anticholinergics
• Any condition that impairs compliance with study protocol including visit schedule and completion of daily diaries
• Any subject with a history of alcohol or substance abuse
• Any affiliation with Investigator's site

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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421 participants in 3 patient groups

Fluticasone Furoate (FF)

Active Comparator group

Description:

100mcg, inhaled

Treatment:

Drug: FF

Fluticasone Furoate /Vilanterol (VI)

Active Comparator group

Description:

100/25mcg inhaled

Treatment:

Drug: FF/VI

Fluticasone Furoate/GSK573719

Experimental group

Description:

100/15.6-250mcg inhaled

Treatment:

Drug: FF/GSK573719

Drug: FF/GSK573719

Drug: FF/GSK573719

Drug: FF/GSK573719

Drug: FF/GSK573719