Examine the Effect of Repeat Inhaled Doses of GW870086X on Lung Function in Mild Asthmatic Male Subjects

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo; Drug: GW870086X

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483899

SIG102335

Details and patient eligibility

About

This study was designed to look at safety aspects and effects of repeat inhaled doses of GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (COPD)

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male subjects aged 18-55
• Documented history of bronchial asthma diagnosed at least 6 months ago.
• Only being treated with short-acting beta-2-agonist therapy e.g. Ventolin
• Documented sensitivity to adenosine mono phosphate (AMP) at screening visit
• Demonstrate repeatable and reproducable response to inhaled AMP at the run-in visit

Exclusion criteria

• Any significant illness or disease
• History of life threatening asthma
• History of respiratory tract infection
• Subjects who take medication for their asthma, or other conditions, not compatible with this study.
• Smoker
• Subjects who are oversensitive to corticosteroids
• History of drug or alcohol abuse
• Donated blood within last 3 months
• Been involved in another clinical trial during the last 3 months
• Subjects who work night shifts
• Subjects who are undergoing de-sensitisation therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups

Cohort 1: Part A

Experimental group

Description:

Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.

Treatment:

Drug: GW870086X

Drug: Placebo

Cohort 2: Part A

Experimental group

Description:

Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.

Treatment:

Drug: GW870086X

Drug: Placebo

Part B

Experimental group

Description:

Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.

Treatment:

Drug: GW870086X

Drug: Placebo