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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02824523
Other study ID # 2016P001164
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2016
Est. completion date May 1, 2021

Study information

Verified date September 2022
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
aspirin


Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic efficacy of high-dose aspirin as assessed by asthma symptom control (Asthma Control Questionnaire) 8 weeks
Primary Therapeutic efficacy of high-dose aspirin as assessed by change in lung function 8 weeks
Primary Therapeutic efficacy of high-dose aspirin as assessed by change in sinus symptoms (Sino-Nasal Outcome Test) 8 weeks
See also
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Active, not recruiting NCT03028350 - Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD) Phase 2
Completed NCT01597375 - Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin) Phase 2
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Completed NCT03326063 - Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban Phase 2