None listed
Conditions
Brief summary
The number of people with asthma has been steadily increasing for many years in most countries of the world including New Zealand, but researchers are not sure why. Some studies have suggested that one reason could be the increasing use of paracetamol. We are aiming to find out if giving paracetamol to people with mild asthma has any effect on their asthma.
Interventions
Subjects randomised to the intervention group will receive paracetamol tablets (1g dose) twice daily for 12 weeks.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Wheeze in the past 12 months and a doctor's diagnosis of asthma 2. Baseline FEV1 greater than or equal to 70% predicted 3. Provocative concentration of methacholine required to achieve a 20% fall in FEV1 (PC20 methacholine) of between 0.125-16.0 mg/ml
Exclusion criteria
1.Patients taking theophylline, ipratropium bromide, tiotropium or leukotriene receptor antagonists regularly in the previous 3 months. 2. An exacerbation of asthma within the previous two months requiring prednisone or nebulised bronchodilator. 3.Current or past cigarette smoking greater than 10 pack years (pack years are calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked). 4.History of allergy or sensitivity to paracetamol or opiates or a history of allergy or sensitivity to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) in subjects who have never taken paracetamol. 5. Current or past history of liver disease or on potentially hepatotoxic drugs. 6. Current use of regular paracetamol, or aspirin greater than 150 mg/day, or high doses of NSAIDs in patients who are unable to discontinue this use during the trial. 7. History of alcoholism, or current excessive alcohol intake. 8. Previous intentional acute overdose of paracetamol, previous suicide attempt or current depression. 9. Evidence of malnutrition or Body Mass Index (BMI) < 16 kg/m2. 10. Pregnant or breastfeeding women or women of child-bearing age not using adequate contraception. 11. Subjects with a screening alanine aminotransferase level above the normal reference range or other screening liver function test abnormalities considered significant by the investigator. 12. Subjects unsuitable for bronchial hyperresponsiveness challenge testing.
Outcome results
None listed