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| Name | Class |
|---|---|
| Rassoul Akram Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Aspirin | Active Comparator | 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. |
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| Control: placebo | Placebo Comparator | Participants will receive placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin | Drug |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hossein Esmaeilzadeh, MD | Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences. | Study Director |
| Mohammad Nabavi, MD | Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences. | Study Chair |
| Zahra Aryan, MD, MPH, student | Molecular Immunology Research Center, Tehran University of Medical Sciences. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences | Tehran | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20728206 | Background | 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. | |
| 20920763 | Background | 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. No abstract available. |
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| ID | Term |
|---|---|
| D055963 | Asthma, Aspirin-Induced |
| D001249 | Asthma |
| D007154 | Immune System Diseases |
| D012130 | Respiratory Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| 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 |
| 18699939 | Background | 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. |
| 18313127 | Background | 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. |
| 14610494 | Background | 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. doi: 10.1016/s0091-6749(03)02015-3. |
| 22643934 | Background | 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. |
| 22627848 | Background | 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. |
| 22525387 | Background | 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. |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |