EUCTR2005-005622-31-GBActive, not recruitingPhase 1
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
niversity of Dundee0 sites20 target enrollmentStarted: January 13, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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