The effect of aspirin in treatment of moderate to severe aspirin-sensitive asthmatic patients

Phase 2

• Conditions: Condition 1: Asthma. Condition 2: Chronic rhinosinusitis. Condition 3: Nasal polyposis.; Mixed asthma Combination of conditions listed in J45.0 and J45.1; J32 (abscess empyema infection suppuration) (chronic) of sinus (accessory)(nasal); Nasal polyposis

• Registration Number: IRCT2015061521970N2
• Lead Sponsor: Vice chancellor for research, Iran Uiversity of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

18 to 65 years old; clinical symptoms of chronic rhinosinusitis with nasal polyposis which confirmed by sinus CT scan; moderate to severe asthma according to the history, spirometric findings and Expert Panel Report 3 (EPR-3) guidelines; receiving the full course of standard treatments for rhinosinusitis and asthma according to the EPR-3 guidelines for 3 months before entering study
Exclusion criteria: presence of serious underlying disease such as bleeding disorders, gastrointestinal, rheumatologic, cancer, heart, kidney, liver and mental diseases; 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; pregnancy; breast-feeding; the use of systemic and topical beta-blocker, angiotensin-converting enzyme inhibitor, angiotensinogen ? receptor blocker, warfarin; mastocytosis; nonadherent patients; patients with high risk jobs or lifestyle

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma symptoms. Timepoint: After 3 and 6 months. Method of measurement: Standard questionnaire Asthma Control Test.;Pulmonary function. Timepoint: After 3 and 6 months. Method of measurement: Spirometry test.

Secondary Outcome Measures

Name	Time	Method
Aspirin side effect: bleeding. Timepoint: Monthly. Method of measurement: Questionnaire.;Aspirin side effect: gastrointestinal disturbance. Timepoint: Monthly. Method of measurement: Questionnaire.;Asthma standard treatment side effect: hoarseness. Timepoint: Monthly. Method of measurement: Questionnaire.;Asthma standard treatment side effect: mouth thrush. Timepoint: Monthly. Method of measurement: Questionnaire.