Asthma, Aspirin-Induced
Conditions
Keywords
aspirin, asthma, Aspirin desensitization, Aspirin induced asthma, Immune System Diseases, Respiratory Hypersensitivity
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).
Interventions
DRUGaspirin
Sponsors
Rassoul Akram Hospital
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Iran
Outcome results
None listed