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

This study has been completed.
Sponsor:
Collaborator:
Rassoul Akram Hospital
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01867281
First received: May 29, 2013
Last updated: June 28, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Asthma, Aspirin-Induced
Drug: aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Aspirin Desensitization on Patients With Aspirin-exacerbated Respiratory Diseases

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Change in SNOT-22 scores from Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    At baseline and 6 months after treatment, serum level of IFN-gamma will be investigated for all participants.


Secondary Outcome Measures:
  • Lund Mackay score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    For all participants, Lund Mackay will be scored by investigators.

  • Asthma attacks [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of asthma attacks will be recorded for all participants over a 6-month follow up.

  • medication needs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period.

  • FEV1 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    FEV1 for all patients will be assessed using spirometery


Enrollment: 32
Study Start Date: June 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867281

Locations
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
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

Publications:

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01867281     History of Changes
Other Study ID Numbers: 92-01-119-20728
Study First Received: May 29, 2013
Last Updated: June 28, 2014
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
aspirin
asthma
Aspirin desensitization
Aspirin induced asthma
Immune System Diseases
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory Tract Diseases
Respiration Disorders
Asthma, Aspirin-Induced
Asthma
Bronchial Diseases
Respiratory Hypersensitivity
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014