The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases
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|ClinicalTrials.gov Identifier: NCT01867281|
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : July 1, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Asthma, Aspirin-Induced||Drug: aspirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: 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.
Placebo Comparator: Control: placebo
Participants will receive placebo
- Change in SNOT-22 scores from Baseline [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants.
- Lund Mackay score [ Time Frame: 6 months ]For all participants, Lund Mackay will be scored by investigators.
- Asthma attacks [ Time Frame: 6 months ]Number of asthma attacks will be recorded for all participants over a 6-month follow up.
- medication needs [ Time Frame: 6 months ]Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period.
- FEV1 [ Time Frame: 6 months ]FEV1 for all patients will be assessed using spirometery
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|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- Being smoker
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867281
|Iran, Islamic Republic of|
|Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences|
|Tehran, Iran, Islamic Republic of|
|Study Director:||Hossein Esmaeilzadeh, MD||Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.|
|Study Chair:||Mohammad Nabavi, MD||Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences.|
|Principal Investigator:||Zahra Aryan, MD, MPH, student||Molecular Immunology Research Center, Tehran University of Medical Sciences.|
|Responsible Party:||Tehran University of Medical Sciences|
|Other Study ID Numbers:||
|First Posted:||June 3, 2013 Key Record Dates|
|Last Update Posted:||July 1, 2014|
|Last Verified:||June 2014|
Aspirin induced asthma
Immune System Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors