CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Placebo Oral Tablet +1 moredrug
Likely dose
Placebo Oral Tablet 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01597375
NCT01597375Phase 2Completed

Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)

Elliot Israel, MD·interventional·Posted May 14, 2012·Updated Sep 19, 2019

In Brief

A Phase 2 clinical trial evaluating Placebo Oral Tablet and Prasugrel Oral Tablet for Asthma, Aspirin-Induced and Aspirin Exacerbated Asthma. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 14, 2012
Enrollment StartAug 31, 2012
Primary CompletionDec 14, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 14.1 years ago

Interventions

Placebo Oral Tabletdrug

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.

Prasugrel Oral Tabletdrug

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.