Clinical Trial: The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
Brief Summary: The purpose of this study is to determine the effect of aspirin desensitization on symptoms and immunologic profile of patients with aspirin-exacerbated respiratory diseases (AERD).
Detailed Summary:
Sponsor: Tehran University of Medical Sciences
Current Primary Outcome:
- Change in SNOT-22 scores from Baseline [ Time Frame: 6 months ]At baseline and 6 months after treatment, all participants will complete the SNOT-22 questionnaire. SNOT-22 is a validated disease specific questionnaire that assesses the health related quality of life patients.
- change in serum concentration of IL-10 [ Time Frame: 6 months ]At baseline and 6 months after treatment, serum level of IL-10 will be investigated for all participants.
- change in concentration of serum TGF-beta [ Time Frame: 6 months ]At baseline and 6 months after treatment, serum level of TGF-beta will be investigated for all participants
- change in concentration of serum IFN-gamma [ Time Frame: 6 months ]At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Lund Mackay score [ Time Frame: 6 months ]For all participants, Lund Mackay will be scored by investigators.
- Asthma attacks [ Time Frame: 6 months ]Number of asthma attacks will be recorded for all participants over a 6-month follow up.
- medication needs [ Time Frame: 6 months ]Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period.
- FEV1 [ Time Frame: 6 months ]FEV1 for all patients will be assessed using spirometery
Original Secondary Outcome: Same as current
Information By: Tehran University of Medical Sciences
Dates:
Date Received: May 29, 2013
Date Started: June 2013
Date Completion:
Last Updated: June 28, 2014
Last Verified: June 2014