| Methods |
Double blind randomised controlled crossover trial. |
| Participants |
156 patients with aspirin‐induced asthma were studies. Oral or inhalation tests with aspirin were performed at least 10 days before the study and were positive in all patients. In the majority of patients oral or inhaled beta‐2 agonists were stopped at least 8 hours previously. In some patients medication was allowed 1‐2 hours before tartrazine challenge as these patients could not do with bronchodilators for longer periods. Age range 16‐63. |
| Interventions |
A multicenter study. Tartrazine was dissolved in water and administered orally at increasing doses of 1, 5, 10 and 25 mg. Placebo was white gelatine capsules. If FEV1 did not fall by >15% 1 hour post tartrazine challenge the next larger dose was given. |
| Outcomes |
FVC, FEV1, PEFR, specific airway resistance. 20% fall in FEV1 defined a positive test result. |
| Notes |
No data provided on placebo arm. Only positive tests to tartrazine provided. No reply to correspondence received from author to date. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
Information not available |
