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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:
ClinicalTrials.gov Identifier:
NCT00483899
First Posted: June 7, 2007
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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
Actual Study Start Date: October 7, 2005
Study Completion Date: December 15, 2006
Primary Completion Date: December 15, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Part A
Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.
Drug: GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Drug: Placebo
Placebo matching GW870086X will be administered by subjects
Experimental: Cohort 2: Part A
Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.
Drug: GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Drug: Placebo
Placebo matching GW870086X will be administered by subjects
Experimental: Part B
Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.
Drug: GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Drug: Placebo
Placebo matching GW870086X will be administered by subjects

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00483899     History of Changes
Other Study ID Numbers: SIG102335
First Submitted: June 5, 2007
First Posted: June 7, 2007
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by GlaxoSmithKline:
GW870086X Asthma Crossover repeat dose inhaled