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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
  Purpose

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)


Condition Intervention Phase
Asthma
Drug: GW870086X
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in lung function 2 hours after treatment on day 7 [ Time Frame: on day 7 ]

Secondary Outcome Measures:
  • 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; ]

Enrollment: 20
Study Start Date: October 2005
Intervention Details:
    Drug: GW870086X
    Other Name: GW870086X
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483899

Locations
United Kingdom
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
GSK Investigational Site
London, United Kingdom, SE5 8AF
GSK Investigational Site
London, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00483899     History of Changes
Other Study ID Numbers: SIG102335
Study First Received: June 5, 2007
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
GW870086X Asthma Crossover repeat dose inhaled

ClinicalTrials.gov processed this record on November 20, 2014