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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483899
• Other study ID #: SIG102335
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2007
• Last updated: September 27, 2017
• Start date: October 7, 2005
• Est. completion date: December 15, 2006

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2006
• Est. primary completion date: December 15, 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
• Placebo
Placebo matching GW870086X will be administered by subjects

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lung function 2 hours after treatment on day 7		on day 7
Secondary	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;

External Links

•   Results for study SIG102335 can be found on the GSK Clinical Study Register.