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Role of Inflammatory Mediators in AERD

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. Identifier: NCT02824523
Recruitment Status : Unknown
Verified January 2019 by Tanya Laidlaw, MD, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
First Posted : July 6, 2016
Last Update Posted : January 16, 2019
Information provided by (Responsible Party):
Tanya Laidlaw, MD, Brigham and Women's Hospital

Brief Summary:
The purpose of this research study is to learn new information about the underlying cause of aspirin-exacerbated respiratory disease (AERD) and the benefit of high-dose aspirin therapy. AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs. This study will be conducted on individuals with AERD who are referred to the Brigham and Women's Hospital AERD Center for clinical evaluation and potential aspirin desensitization. Desensitization to aspirin and subsequent treatment with daily high-dose oral aspirin is standard of care for patients with AERD who do not respond adequately to steroids and have recurrent nasal polyposis or symptomatic asthma. This study will involve five visits to Brigham and Women's Hospital and will align closely with the standard of care for the treatment of AERD.

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Role of PDG2 in the Aspirin-Induced Reactions and in the Treatment of Aspirin-Exacerbated Respiratory Disease
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Aspirin

Group/Cohort Intervention/treatment
High-dose aspirin Drug: aspirin

Primary Outcome Measures :
  1. Therapeutic efficacy of high-dose aspirin as assessed by asthma symptom control (Asthma Control Questionnaire) [ Time Frame: 8 weeks ]
  2. Therapeutic efficacy of high-dose aspirin as assessed by change in lung function [ Time Frame: 8 weeks ]
  3. Therapeutic efficacy of high-dose aspirin as assessed by change in sinus symptoms (Sino-Nasal Outcome Test) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with aspirin-exacerbated respiratory disease who are undergoing aspirin desensitization and starting high-dose aspirin therapy

Inclusion Criteria:

  • History of asthma
  • History of nasal polyposis
  • History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement
  • Stable asthma (post-bronchodilator FEV1 of ≥70%, no use of oral or systemic steroids for at least 1 month, and no hospitalizations or emergency room visits for asthma for the prior 6 months) at the time of entry into the study
  • Currently taking montelukast as part of standard asthma treatment for at least 4 weeks before the V1 visit

Exclusion criteria:

  • Pregnancy or current breastfeeding
  • History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
  • History of thrombocytopenia < 50 x 10^9/L
  • Hypersensitivity to montelukast
  • Peptic ulcer disease
  • Unstable asthma (post-bronchodilator FEV1 of less than 70%, use of oral or systemic steroids for at least 1 month prior to visit 1, or hospitalizations or emergency room visits for asthma for the prior 6 months)
  • Use of zileuton (which can mask symptoms of aspirin-induced reaction) within 1 month prior to the V1 visit
  • Age under 18 or over 75 years
  • Current smoking

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 identifier (NCT number): NCT02824523

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Contact: Joseph Singer 617-525-1284

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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Joseph Singer    617-525-1267   
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Tanya M Laidlaw, MD Brigham and Women's Hospital
Principal Investigator: Katherine C Cahill, MD Brigham and Women's Hospital
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Responsible Party: Tanya Laidlaw, MD, Associate Physician, Brigham and Women's Hospital Identifier: NCT02824523    
Other Study ID Numbers: 2016P001164
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Keywords provided by Tanya Laidlaw, MD, Brigham and Women's Hospital:
nasal polyps
aspirin sensitivity
Additional relevant MeSH terms:
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Asthma, Aspirin-Induced
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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