Clinical trial comparing the effects of low dose aspirin and placebo on clinical improvement of moderate to severe aspirin-sensitive asthmatic patients with chronic rhinosinusitis and nasal polyposis

Objective: Comparing effects of low dose aspirin and placebo on clinical improvement of moderate to severe aspirin sensitive asthmatic patients with chronic rhinosinusitisI (CRS) and nasal polyposis Design: Balanced Block Randomization, double blinded, placebo used, single center, trial phase 2 Major Inclusion criteria: 18 to 65 years old patients with moderate to severe aspirin sensitive asthma with CRS and nasal polyposis based on history, physical exam, spirometric and sinus CT scan findings and Expert Panel Report 3 (EPR-3) guidelines and receiving rhinosinusitis and asthma standard treatments (according to the EPR-3 guidelines) for 3 months. Major Exclusion criteria: Serious underlying disease; medical history of immediate hypersensitivity reactions to aspirin and nonsteroidal anti-inflammatory drugs; Forced Expiratory Volume in the first second (FEV1) less than 70% at the time of aspirin challenge; using of medication interfering with aspirin challenge Sample size: 10 patients in each treatment group (totally: 30 patients) Interventions: Aspirin challenge is performed after obtaining informed consent .Those with positive aspirin challenge are desensitized and randomly and blindly are placed in 3 treatment groups with 100 mg aspirin daily, 325 mg aspirin daily or placebo daily for 6 months. Patients and physicians are not aware of 3 treatment groups. Main outcome measures: Evaluation of asthma symptoms according to the ACT questionnaire, spirometric findings and treatment side effects before and after 3 and 6 months of intervention and the effects of low dose aspirin and placebo on clinical improvement of moderate to severe aspirin-sensitive asthmatic patients with CRSand nasal polyposis are compared.

Vice chancellor for research, Iran Uiversity of Medical Sciences