Clinical trial NCT01867281: The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
Official title: The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma, Aspirin-Induced
Keywords: aspirin
asthma
Aspirin desensitization
Aspirin induced asthma
Immune System Diseases
Respiratory Hypersensitivity
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Rassoul Akram Hospital
First posted: 2013-06-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in SNOT-22 scores from Baseline
timeFrame: 6 months
measure: change in serum concentration of IL-10
timeFrame: 6 months
measure: change in concentration of serum TGF-beta
timeFrame: 6 months
measure: change in concentration of serum IFN-gamma
timeFrame: 6 months
Secondary outcomes:
measure: Lund Mackay score
timeFrame: 6 months
measure: Asthma attacks
timeFrame: 6 months
measure: medication needs
timeFrame: 6 months
measure: FEV1
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences
Study officials:
affiliation: Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.
name: Hossein Esmaeilzadeh, MD
role: STUDY_DIRECTOR
affiliation: Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.
name: Mohammad Nabavi, MD
role: STUDY_CHAIR
affiliation: Molecular Immunology Research Center, Tehran University of Medical Sciences.
name: Zahra Aryan, MD, MPH, student
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. No abstract available.
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.
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.
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. doi: 10.1016/s0091-6749(03)02015-3.
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.
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.
citation: 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.