None listed
Conditions
Interventions
Intervention1: paracetamol: 1gm BD for 15 days
Control Intervention1: placebo: 1 gm BD for 15 days
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: ? Mild- to-moderate asthmatics in accordance with the GINA guidelines ? Male and females18?70 years old ? Baseline FEV1 ≥60% predicted ? PC20 methacholine of ≤8.0 mg/ml
Exclusion criteria
Exclusion criteria: ? Subjects with aspirin induced asthma ? Asthmatics with exacerbation of asthma within the previous three months requiring oral steroids, nebulised bronchodilator, antibiotics or an emergency visit to the doctor ? Current or past cigarette smoking >10 pack years ? History of allergy or sensitivity to paracetamol, aspirin or ibuprofen ? Current or past history of liver disease or on potentially hepatotoxic drugs ? Deranged liver function, signified by elevated enzyme levels ? Current regular use of paracetamol ? History of alcoholism, or current excessive alcohol intake ? Previous intentional acute overdose of paracetamol, previous suicide attempt or current depression ? Evidence of malnutrition or BMI <20 kg/m2 ? Women of child-bearing age not using adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable will be the effect of paracetamol on PC20 methacholine in asthmatic subjects.Timepoint: 0, 7 and 15 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of Paracetamol on: ? Spirometric parameters: lung volumes (FEV1 and FVC) and flow rates (FEF 25-75%) ? Impulse oscillometry (IOS) parameters: resistance at 5 Hz (R 5 Hz), resistance at 20 Hz (R 20 Hz), small airway resistance (R 5 Hz - R 20 Hz), reactance (X 5 Hz) and airway conductance ? eCO ? Liver function tests, blood eosinophil, whole blood glutathione peroxidase (GSH + GSSG), GSH and the ratio of GSH/GSSG ( normally >10) will also be assessed. Timepoint: 0, 7 and 15 days. | — |
Countries
India
Contacts
Public ContactDr Bill Brashier, Dr Susheel Kapoor
Outcome results
None listed