Last updated: 11/07/2018 00:20:37
The Effect Of AVANDIA On The Late Asthmatic Response
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo
Trial description: This study is to investigate the effects of AVANDIA on the asthmatic response.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
The effect of repeat oral doses of AVANDIA for 28 days on the late asthmatic response to inhaled allergen. Measured as lung function 4-10 hours after allergen challenge after 28 days dosing.
Timeframe: Up to 43 days
Secondary outcomes:
The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability.
Timeframe: Up to 43 days
Interventions:
Drug: Rosiglitazone
Drug: Placebo
Enrollment:
26
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Asthma
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
July 2005 to June 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
- Mild asthmatic treated with short-acting beta agonists only, non-smoker.
- Inability to abstain from medications other than short-acting beta agonists and paracetamol.
- Recent administration of steroids.
Inclusion and exclusion criteria
Inclusion criteria:
- Mild asthmatic treated with short-acting beta agonists only, non-smoker.
Exclusion criteria:
- Inability to abstain from medications other than short-acting beta agonists and paracetamol.
- Recent administration of steroids.
- Recent respiratory infection or exacerbation of asthma.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
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
2006-30-06
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 104385 can be found on the GSK Clinical Study Register.
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