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

Double-blind, Placebo-controlled, 3-way Crossover Study to Investigate the Effect of 7-days Repeat Once Daily Inhaled Doses of GW870086X Administered Via DISKHALER on Airway Responsiveness to AMP in Mild Steroid-naive Male Asthmatics

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00483899

Enrollment

Registered

2007-06-07

Start date

2005-10-07

Completion date

2006-12-15

Last updated

2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

GW870086X Asthma Crossover repeat dose inhaled

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)

Interventions

DRUGGW870086X

Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times

DRUGPlacebo

Placebo matching GW870086X will be administered by subjects

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Change in lung function 2 hours after treatment on day 7	on day 7

Secondary

Measure	Time frame
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;

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026