The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
NCT ID: NCT01867281
Last Updated: 2014-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2013-06-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention: Aspirin
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.
aspirin
Control: placebo
Participants will receive placebo
No interventions assigned to this group
Interventions
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aspirin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Rassoul Akram Hospital
OTHER
Tehran University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Hossein Esmaeilzadeh, MD
Role: STUDY_DIRECTOR
Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.
Mohammad Nabavi, MD
Role: STUDY_CHAIR
Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.
Zahra Aryan, MD, MPH, student
Role: PRINCIPAL_INVESTIGATOR
Molecular Immunology Research Center, Tehran University of Medical Sciences.
Locations
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Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences
Tehran, Tehran Province, Iran
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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92-01-119-20728
Identifier Type: -
Identifier Source: org_study_id
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