Examine the Effect of Repeat Inhaled Doses of GW870086X on Lung Function in Mild Asthmatic Male Subjects
NCT ID: NCT00483899
Last Updated: 2017-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2005-10-07
2006-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Cohort 1: Part A
Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.
GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Placebo
Placebo matching GW870086X will be administered by subjects
Cohort 2: Part A
Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.
GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Placebo
Placebo matching GW870086X will be administered by subjects
Part B
Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.
GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Placebo
Placebo matching GW870086X will be administered by subjects
Interventions
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GW870086X
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
Placebo
Placebo matching GW870086X will be administered by subjects
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Manchester, Lancashire, United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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Other Identifiers
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SIG102335
Identifier Type: -
Identifier Source: org_study_id