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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867281
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : July 1, 2014
Sponsor:
Collaborator:
Rassoul Akram Hospital
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Study Description
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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).

Condition or disease Intervention/treatment Phase
Asthma, Aspirin-Induced Drug: aspirin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: aspirin
Placebo Comparator: Control: placebo
Participants will receive placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. Lund Mackay score [ Time Frame: 6 months ]
    For all participants, Lund Mackay will be scored by investigators.

  2. Asthma attacks [ Time Frame: 6 months ]
    Number of asthma attacks will be recorded for all participants over a 6-month follow up.

  3. medication needs [ Time Frame: 6 months ]
    Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period.

  4. FEV1 [ Time Frame: 6 months ]
    FEV1 for all patients will be assessed using spirometery


Eligibility Criteria
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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Iran, Islamic Republic of
Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Rassoul Akram Hospital
Investigators
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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.
More Information
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Publications:

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01867281    
Other Study ID Numbers: 92-01-119-20728
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014
Keywords provided by Tehran University of Medical Sciences:
aspirin
asthma
Aspirin desensitization
 Aspirin induced asthma
Immune System Diseases
Respiratory Hypersensitivity
Additional relevant MeSH terms:
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Asthma
Respiration Disorders
Respiratory Tract Diseases
Asthma, Aspirin-Induced
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Aspirin
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics