Clinical trial NCT01597375
Conditions: Asthma, Aspirin-Induced Aspirin Exacerbated Asthma
Keywords: Aspirin Prasugrel Asthma AERD Aspirin challenge Aspirin desensitization Aspirin induced asthma
Sponsor: Elliot Israel, MD
Start date: 2012-08-31; Completion date: 2016-12-14
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Detailed description:

Arms: arm 1: Subjects with AERD first received placebo oral tablet for 4 weeks prior to their aspirin challenge/desensitization. After aspirin challenge/desensitization subjects were discharged to home to washout the study drug from the first treatment phase. At the end of the 2-week washout period, subjects crossed over to the alternate treatment for 4 weeks of Prasugrel oral tablets \[ (5 mg (for patients \<60kg) or 10mg (\> 60kg) daily, following a 60mg loading dose)\] and returned for the second aspirin challenge.

Because no period effect was observed, data obtained from all subjects while on placebo from either visit 2 or 3 were combined. arm 2: Subjects with AERD first received prasugrel oral tablets \[ (5 mg (for patients \<60kg) or 10mg (\> 60kg) daily, following a 60mg loading dose)\] prior to their aspirin challenge/desensitization. After aspirin challenge/desensitization subjects were discharged to home to washout the study drug from the first treatment phase. At the end of the 2-week washout period, subjects crossed over to the alternate treatment for 4 weeks of Placebo oral tablet.

Because no period effect was observed, data obtained from all subjects while on Prasugrel from either visit 2 or 3 were combined.
Interventions: intervention 1: Placebo Oral Tablet intervention 2: Prasugrel Oral Tablet
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents: