Last updated: 11/04/2018 12:07:45
Examine the effect of repeat inhaled doses of GW870086X on lung function in mild asthmatic male subjects
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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)
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change in lung function 2 hours after treatment on day 7
Timeframe: on day 7
Secondary outcomes:
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
Timeframe: 2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;
Interventions:
Drug: GW870086X
Drug: Placebo
Enrollment:
20
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
GW870086
Collaborators
Not applicable
Study date(s)
October 2005 to December 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
No
- Male subjects aged 18-55
- Documented history of bronchial asthma diagnosed at least 6 months ago.
- Any significant illness or disease
- History of life threatening asthma
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-15-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study SIG102335 can be found on the GSK Clinical Study Register.
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