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Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)

NCT01597375 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-09-19

Study results available
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Summary

The investigators are doing this research study to find out if giving a drug called prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every day can work as a treatment for people with AERD. People with AERD have symptoms of asthma, severe runny nose, polyps in the nose, and develop allergic reactions if they take medications like aspirin.

People with AERD can be desensitized to aspirin in order to be able to safely use it daily, but the investigators do not know if prasugrel may prevent reactions to aspirin and provide a safer way for people with AERD to tolerate aspirin.

The investigators also want to understand what is different about the cells and urine from subjects who have AERD, in comparison to subjects who have asthma but do not have AERD and subjects who have allergic rhinitis but do not have asthma. Lastly, the investigators want to understand how aspirin acts differently in subjects who have AERD, in comparison to subjects who have asthma but do not have AERD.

Conditions

  • Asthma, Aspirin-Induced
  • Aspirin Exacerbated Asthma

Interventions

DRUG

Placebo Oral Tablet

Participants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh \>60kg or 5 mg by mouth daily if they weigh \<60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization.

DRUG

Prasugrel Oral Tablet

Participants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh \>60kg or 5 mg by mouth daily if they weigh \<60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Elliot Israel, MD

    lead OTHER

Principal Investigators

  • Elliot Israel, MD · Brigham and Women's Hospital

  • Joshua Boyce, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-12-14
Completion
2016-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597375 on ClinicalTrials.gov