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Clinical Trials/EUCTR2005-005622-31-GB
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

Sponsor
niversity of Dundee

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