The effect of regular paracetamol use on the airways in asthma.
- Conditions
- AsthmaRespiratory - Asthma
- Registration Number
- ACTRN12610000729022
- Lead Sponsor
- Medical Research Institute of New Zealand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
1. A doctor’s diagnosis of asthma plus wheeze in the previous 12 months and asthma inhaler use in the previous 12 months
2.18 – 65 years old
1.Patients currently taking a long acting beta agonist (LABA), tiotropium or theophylline.
2.An exacerbation of asthma within the previous 6 weeks requiring prednisone, or nebulised bronchodilator.
3.Current or past cigarette smoking > 10 pack years.
4.History of allergy, sensitivity, potential significant drug interaction or other contra-indication to paracetamol
5.History of liver disease
6.Patients with a current history of regular use of paracetamol, who are unwilling or unable to discontinue use of this medication during the trial period.
7.Previous suicide attempt or current depression score of > 13 on the Hamilton Depression Rating Score (HDRS).
8.Body Mass Index (BMI) < 16.0 kg/m2.
9.Pregnant or breast-feeding women and women of child-bearing age not using adequate contraception.
10.Unable to perform or master techniques of pulmonary function testing.
11.Any other safety concern at the investigator’s discretion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Airways resistance at 5Hz measured using an impulse oscillometry system (IOS)[14 days after commencement of treatment.];Airways resistance at 20Hz measured using an impulse oscillometry system (IOS)[14 days after commencement of treatment.]
- Secondary Outcome Measures
Name Time Method Forced expiratory volume in one second (FEV1) using spirometry.[14 days after commencement of treatment.];Fraction of exhaled nitric oxide (FeNO) using an exhaled nitric oxide gas analyser.[14 days after commencement of treatment.];Airways reactance at 5Hz (X5) using an impulse oscillometry system (IOS).[14 days after commencement of treatment.];Peripheral airways resistance (R5-20Hz) using an impulse oscillometry system (IOS).[14 days after commencement of treatment.];Markers of oxidative stress and prostaglandin metabolism present in the urine measured by enzyme immunoassay and mass spectrometry.[Baseline and 14 days after commencement of treatment.]