Asthma, Aspirin-Induced Clinical Trial
Official title:
The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
Verified date | June 2014 |
Source | Tehran University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics Committee |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 32 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences | Tehran |
Lead Sponsor | Collaborator |
---|---|
Tehran University of Medical Sciences | Rassoul Akram Hospital |
Iran, Islamic Republic of,
Chang JE, White A, Simon RA, Stevenson DD. Aspirin-exacerbated respiratory disease: burden of disease. Allergy Asthma Proc. 2012 Mar-Apr;33(2):117-21. doi: 10.2500/aap.2012.33.3541. Review. — View Citation
Higashi N, Taniguchi M, Mita H, Yamaguchi H, Ono E, Akiyama K. Aspirin-intolerant asthma (AIA) assessment using the urinary biomarkers, leukotriene E4 (LTE4) and prostaglandin D2 (PGD2) metabolites. Allergol Int. 2012 Sep;61(3):393-403. doi: 10.2332/allergolint.11-RA-0403. Epub 2012 May 25. Review. — View Citation
Katial RK, Strand M, Prasertsuntarasai T, Leung R, Zheng W, Alam R. The effect of aspirin desensitization on novel biomarkers in aspirin-exacerbated respiratory diseases. J Allergy Clin Immunol. 2010 Oct;126(4):738-44. doi: 10.1016/j.jaci.2010.06.036. Epub 2010 Aug 21. — View Citation
Menzies D, Nair A, Meldrum KT, Hopkinson P, Lipworth BJ. Effect of aspirin on airway inflammation and pulmonary function in patients with persistent asthma. J Allergy Clin Immunol. 2008 May;121(5):1184-1189.e4. doi: 10.1016/j.jaci.2008.01.009. Epub 2008 Mar 4. — View Citation
Rozsasi A, Polzehl D, Deutschle T, Smith E, Wiesmiller K, Riechelmann H, Keck T. Long-term treatment with aspirin desensitization: a prospective clinical trial comparing 100 and 300 mg aspirin daily. Allergy. 2008 Sep;63(9):1228-34. doi: 10.1111/j.1398-9995.2008.01658.x. — View Citation
Swierczynska M, Nizankowska-Mogilnicka E, Zarychta J, Gielicz A, Szczeklik A. Nasal versus bronchial and nasal response to oral aspirin challenge: Clinical and biochemical differences between patients with aspirin-induced asthma/rhinitis. J Allergy Clin Immunol. 2003 Nov;112(5):995-1001. — View Citation
Vaidyanathan S, Williamson PA, Lipworth BJ. Is a positive nasal lysine-aspirin challenge test associated with a more severe phenotype of chronic rhinosinusitis and asthma? Am J Rhinol Allergy. 2012 May-Jun;26(3):e89-93. doi: 10.2500/ajra.2012.26.3767. — View Citation
White AA, Stevenson DD. Does suppression of IL-4 synthesis by aspirin explain the therapeutic benefit of aspirin desensitization treatment? J Allergy Clin Immunol. 2010 Oct;126(4):745-6. doi: 10.1016/j.jaci.2010.08.037. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
Secondary | Lund Mackay score | For all participants, Lund Mackay will be scored by investigators. | 6 months | No |
Secondary | Asthma attacks | Number of asthma attacks will be recorded for all participants over a 6-month follow up. | 6 months | Yes |
Secondary | medication needs | Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period. | 6 months | Yes |
Secondary | FEV1 | FEV1 for all patients will be assessed using spirometery | 6 months | Yes |
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