NCT01597375

Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Elliot Israel, MD · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-08-31
• Primary completion: 2016-12-14
• Completion: 2016-12-14
• First posted: 2012-05-14
• Last updated: 2019-09-19
• Results posted: 2018-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study