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Completed

NCT Number: NCT01867281

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

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).

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Key information

Conditions

Asthma, Aspirin-Induced Asthma Bronchial Diseases Chemically-Induced Disorders Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Allergy and Immunology, Rasool-e-Akram Hospital, Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Rassoul Akram Hospital

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2013
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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