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

Study Overview
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Brief Summary
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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).

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

Conditions
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Asthma, Aspirin-Induced

Intervention / Treatment
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* Drug: aspirin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention: Aspirin<br>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. | Drug: aspirin<br> <br> |
| Placebo Comparator: Control: placebo<br>Participants will receive placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SNOT-22 scores from Baseline | 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. | 6 months | 
| change in serum concentration of IL-10 | At baseline and 6 months after treatment, serum level of IL-10 will be investigated for all participants. | 6 months | 
| change in concentration of serum TGF-beta | At baseline and 6 months after treatment, serum level of TGF-beta will be investigated for all participants | 6 months | 
| change in concentration of serum IFN-gamma | At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants. | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, asthma, Aspirin desensitization, Aspirin induced asthma, Immune System Diseases, Respiratory Hypersensitivity