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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: GW870086X; Drug: Placebo

• Registration Number: NCT00483899
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-07
• Primary Completion: 2006-12-15
• Study Completion: 2006-12-15
• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-05
• Study First Posted: 2007-06-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1: Part A	Placebo	Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.
Cohort 2: Part A	GW870086X	Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.
Cohort 1: Part A	GW870086X	Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.
Cohort 2: Part A	Placebo	Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.
Part B	GW870086X	Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.
Part B	Placebo	Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.

Primary Outcome Measures

Name	Time	Method
Change in lung function 2 hours after treatment on day 7	on day 7

Secondary Outcome Measures

Name	Time	Method
Change in lung function 14 and 26 hours after treatment on day 7; Change in lung function 2 hours after treatment on day 1; Effects on blood and urine tests; effects on the heart, pulse rate and blood pressure; effects on the lungs	2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom