The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases

Phase 4

Completed

• Conditions: Asthma, Aspirin-Induced
• Interventions: Drug: aspirin

• Registration Number: NCT01867281
• Lead Sponsor: Tehran University of Medical Sciences

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-29
• Study Start: 2013-06
• Study First Posted: 2013-06-03
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-28
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients with clinical diagnose of aspirin-exacerbated respiratory disease
• History of physician diagnosed asthma.
• History of physiacian diagnosed chronic rhinosinositis with nasal polyps.
• Positive reaction to aspirin challenge test.
• Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).

Exclusion Criteria

• Being smoker
• pregnancy
• Current breastfeeding
• History of bleeding diathesis
• History of transient ischemic attack or stroke, or diabetes.
• History of abnormal hepatic function
• Uncontrolled hypertension or use of beta blocker medication.
• History of gastrointestinal ulcers or gastrointestinal bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Aspirin	aspirin	Participants will undergo aspirin desensitization over a 2-day period with increasing doses of aspirin (60, 125, 325 and 625 mg). Thereafter,they will be followed with 625 mg aspirin bid.

Primary Outcome Measures

Name	Time	Method
Change in SNOT-22 scores from Baseline	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	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	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	6 months	At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants.

Secondary Outcome Measures

Name	Time	Method
Lund Mackay score	6 months	For all participants, Lund Mackay will be scored by investigators.
Asthma attacks	6 months	Number of asthma attacks will be recorded for all participants over a 6-month follow up.
medication needs	6 months	Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period.
FEV1	6 months	FEV1 for all patients will be assessed using spirometery

Trial Locations

Locations (1)

Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of