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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GW870086X
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring GW870086X Asthma Crossover repeat dose inhaled

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept 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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1: Part A

Cohort 2: Part A

Part B

Arm Description

Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.

Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.

Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.

Outcomes

Primary Outcome Measures

Change in lung function 2 hours after treatment 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

Full Information

First Posted
June 5, 2007
Last Updated
September 27, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00483899
Brief Title
Examine the Effect of Repeat Inhaled Doses of GW870086X on Lung Function in Mild Asthmatic Male Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 7, 2005 (Actual)
Primary Completion Date
December 15, 2006 (Actual)
Study Completion Date
December 15, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
GW870086X Asthma Crossover repeat dose inhaled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Part A
Arm Type
Experimental
Arm Description
Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.
Arm Title
Cohort 2: Part A
Arm Type
Experimental
Arm Description
Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.
Arm Title
Part B
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.
Intervention Type
Drug
Intervention Name(s)
GW870086X
Intervention Description
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching GW870086X will be administered by subjects
Primary Outcome Measure Information:
Title
Change in lung function 2 hours after treatment on day 7
Time Frame
on day 7
Secondary Outcome Measure Information:
Title
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;

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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