Asthma
Conditions
Interventions
Trade Name: Nu-Seals 75
Product Name: Aspirin
Pharmaceutical Form: Tablet
INN or Proposed INN: Acetyl Salicylic Acid
Other descriptive name: Aspirin
Concentration unit: mg milligram(s)
Concentration t
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether aspirin has a beneficial effect on airway hyper-responsiveness in asthmatic patients;Secondary Objective: To determine whether aspirin has a beneficial effect on airway inflammation in asthmatic patients;Primary end point(s): Methacholine hyper-responsiveness | — |
Countries
United Kingdom
Outcome results
None listed