Efficacy and Safety Study in Subjects With Asthma

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Dose 3 QD; Drug: placebo; Drug: Dose 1 BD; Drug: Dose 4 QD; Drug: Dose 2 QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00980200

113310

Details and patient eligibility

About

The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.

Full description

The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an FEV1 of between 40-85% of predicted normal and with airway reversibility as demonstrated by an increase in FEV1 of ≥12% and ≥200ml .

Efficacy assessments include 24-hour serial lung function testing. Safety assessments include incidence of adverse events and measurement of vital signs.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient
• ≥18 years of age at Visit 1
• Male or Eligible Female
• Diagnosis of asthma at least 12 weeks prior to Visit 1
• Disease reversibility
• Current anti-asthma therapy
• Appropriately signed and dated informed consent has been obtained
• Able to comply with all the study requirements

Exclusion criteria

• History of Life-Threatening Asthma
• No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
• No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation
• Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate
• History of severe milk protein allergy
• Non-compliance with study medication and other study-related requirements
• No use of inhaled tobacco products within the past three months or historical use of 10 pack years or more
• Administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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75 participants in 5 patient groups

C/E/A/B/D

Experimental group

Description:

GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD/GW642444 Dose 3 QD

Treatment:

Drug: Dose 2 QD

D/C/E/A/B

Experimental group

Description:

GW642444 Dose 3 QD/GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD

Treatment:

Drug: Dose 3 QD

A/B/C/D/E

Experimental group

Description:

placebo/GW642444 Dose 1 BD/GW642444 Dose 2 QD/GW642444 Dose 3 QD/GW642444 Dose 4 QD

Treatment:

Drug: placebo

B/A/D/E/C

Experimental group

Description:

GW642444 Dose 1 BD/placebo/GW642444 Dose 3 QD/GW642444 Dose 4 QD/GW642444 Dose 2 QD

Treatment:

Drug: Dose 1 BD

E/D/B/C/A

Experimental group

Description:

GW642444 Dose 4 QD/GW642444 Dose 3 QD/GW642444 Dose 1 BD/GW642444 Dose 2 QD/placebo

Treatment:

Drug: Dose 4 QD