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
Sponsored by
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
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
No
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
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.
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
No
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
background
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
background
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
background
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
background
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
background
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
background
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
background
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The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
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