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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00483899
First received: June 5, 2007
Last updated: May 31, 2012
Last verified: February 2011

June 5, 2007
May 31, 2012
October 2005
Not Provided
Change in lung function 2 hours after treatment on day 7 [ Time Frame: on day 7 ]
Same as current
Complete list of historical versions of study NCT00483899 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7; ]
Same as current
Not Provided
Not Provided
 
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

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)

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: GW870086X
Other Name: GW870086X
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
Not Provided

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
Male
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00483899
SIG102335
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP