A Proof Of Concept Study To Investigate The Potential Role Of Acetylsalicyclic Acid (Aspirin) As An Anti-Inflammatory Agent For The Treatment Of Asthma - Aspirin as an anti-inflammatory agent in the treatment of asthma
- Conditions
- Asthma
- Registration Number
- EUCTR2005-005622-31-GB
- Lead Sponsor
- niversity of Dundee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1.Informed consent
2.Mild to moderate persistent stable asthma with an FEV1 of >60% of predicted
3.Males or females aged 18-65
4.A documented MCh PC10 of less than 4mg/ml at visit 1
5.Known tolerance to systemic NSAID treatment
6.Ability to comply with the requirements of the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Daily requirement of >800mg BDP or equivalent of ICS
2.Instability of control after or during ICS withdrawal, or after withdrawal of second line agents
3.Known or suspected hypersensitivity to any of the IMP’s in particular NSAID intolerance
4.Previous or current history (suggestive or definite) of upper gastro-intestinal bleeding or peptic ulcer disease
5.Use of oral corticosteroids within the last 3 months
6.A respiratory tract infection within the last 2 months
7.Any concomitant medical condition that may either endanger the safety of the participant, or compromise the trial protocol. This can include significantly abnormal screening blood test results.
8.Pregnancy, planned pregnancy or lactation
9.Current treatment with aspirin or non-steroidal anti-inflammatory medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method