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

June 28, 2014 updated by: Tehran University of Medical Sciences
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lund Mackay score
Time Frame: 6 months
For all participants, Lund Mackay will be scored by investigators.
6 months
Asthma attacks
Time Frame: 6 months
Number of asthma attacks will be recorded for all participants over a 6-month follow up.
6 months
medication needs
Time Frame: 6 months
Medication needs to relief respiratory symptoms will be recorded for all participants over a 6-month period.
6 months
FEV1
Time Frame: 6 months
FEV1 for all patients will be assessed using spirometery
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Collaborators

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 29, 2013

First Posted (ESTIMATE)

June 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 28, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 92-01-119-20728

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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