The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases

Asthma, Aspirin-Induced Clinical Trial

Official title:

The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867281
• Other study ID #: 92-01-119-20728
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2013
• Last updated: June 28, 2014
• Start date: June 2013
• Est. completion date: June 2014

Study information

• 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

Clinical Trial 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).

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma, Aspirin-Induced
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Drug:
• aspirin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Rassoul Akram Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (8)

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

Outcome

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