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

Primary Purpose

Asthma, Aspirin-Induced

Status

Completed

Phase

Phase 4

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

aspirin

About this trial

This is an interventional treatment trial for Asthma, Aspirin-Induced focused on measuring aspirin, asthma, Aspirin desensitization, Aspirin induced asthma, Immune System Diseases, Respiratory Hypersensitivity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention: Aspirin

Control: placebo

Arm Description

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.

Participants will receive placebo

Outcomes

Primary Outcome Measures

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.

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.

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

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.

Secondary Outcome Measures

Lund Mackay score

For all participants, Lund Mackay will be scored by investigators.

Asthma attacks

Number of asthma attacks will be recorded for all participants over a 6-month follow up.

medication needs

Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period.

FEV1

FEV1 for all patients will be assessed using spirometery

Full Information

NCT ID

NCT01867281

First Posted

May 29, 2013

Last Updated

June 28, 2014

Sponsor

Tehran University of Medical Sciences

Collaborators

Rassoul Akram Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01867281

Brief Title

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

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tehran University of Medical Sciences

Collaborators

Rassoul Akram Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Aspirin-Induced

Keywords

aspirin, asthma, Aspirin desensitization, Aspirin induced asthma, Immune System Diseases, Respiratory Hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention: Aspirin

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Control: placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo

Intervention Type

Drug

Intervention Name(s)

aspirin

Primary Outcome Measure Information:

Title

Change in SNOT-22 scores from Baseline

Description

Time Frame

6 months

Title

change in serum concentration of IL-10

Description

At baseline and 6 months after treatment, serum level of IL-10 will be investigated for all participants.

Time Frame

6 months

Title

change in concentration of serum TGF-beta

Description

At baseline and 6 months after treatment, serum level of TGF-beta will be investigated for all participants

Time Frame

6 months

Title

change in concentration of serum IFN-gamma

Description

At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Lund Mackay score

Description

For all participants, Lund Mackay will be scored by investigators.

Time Frame

6 months

Title

Asthma attacks

Description

Number of asthma attacks will be recorded for all participants over a 6-month follow up.

Time Frame

6 months

Title

medication needs

Description

Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period.

Time Frame

6 months

Title

FEV1

Description

FEV1 for all patients will be assessed using spirometery

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hossein Esmaeilzadeh, MD

Organizational Affiliation

Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohammad Nabavi, MD

Organizational Affiliation

Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Zahra Aryan, MD, MPH, student

Organizational Affiliation

Molecular Immunology Research Center, Tehran University of Medical Sciences.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

20728206

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.

Results Reference

background

PubMed Identifier

20920763

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.

Results Reference

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PubMed Identifier

18699939

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.

Results Reference

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PubMed Identifier

18313127

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.

Results Reference

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PubMed Identifier

14610494

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.

Results Reference

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PubMed Identifier

22643934

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.

Results Reference

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PubMed Identifier

22627848

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.

Results Reference

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PubMed Identifier

22525387

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.

Results Reference

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

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