Phase 2 N=46 Randomized Triple-blind Supportive Care

Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)

Asthma, Aspirin-Induced · Aspirin Exacerbated Asthma

Bottom Line

View on ClinicalTrials.gov: NCT01597375 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Difference in PD2 (Provocative Dose of Aspirin That Elicits an Increase in Nasal Symptom Score of 2 During an Aspirin Challenge) on Prasugrel Versus Placebo — 79; 139 mg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo Oral Tablet (Drug); Prasugrel Oral Tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Elliot Israel, MD
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in PD2 (Provocative Dose of Aspirin That Elicits an Increase in Nasal Symptom Score of 2 During an Aspirin Challenge) on Prasugrel Versus Placebo	79; 139	—
PRIMARY Change From Baseline Expression Levels of COX-2 Transcript and Protein in Peripheral Blood Leukocytes of Subjects With AERD After 8 Weeks of Treatment With Aspirin.	—	—
SECONDARY Difference in Participant's Provocative Dose of Aspirin When Pretreated With Prasugrel Versus Placebo	109; 164	—
SECONDARY Change in Total Nasal Symptom Score(TNSS)From Baseline to Peak During Aspirin Challenge on Placebo Versus Prasugrel.	7; 6.5	—
SECONDARY Change in Urinary LTE4 During Aspirin Challenge on Placebo Versus Prasugrel	37; 19	—
SECONDARY Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks	15.8	—
SECONDARY Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Score After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks	-0.11	—
SECONDARY Change From Baseline in Prostaglandin Metabolites (PGD-M) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks	-1.4957	—

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.

Eligibility Criteria

Inclusion Criteria for Participants with AERD:

History of physician-diagnosed asthma
History of nasal polyposis
History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement.
Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).
No current smoking, defined as no daily tobacco smoking for at least 6 months and not more than one instance of tobacco smoking in the last 3 months.
Non-pregnant
Only those individuals who would otherwise meet clinical qualifications for aspirin desensitization and treatment with high-dose aspirin will be considered for enrollment in the study.

Inclusion Criteria for Participants who are Aspirin Tolerant Asthmatics:

History of physician-diagnosed asthma.
No current nasal polyposis confirmed by nasal examination.
No history of any adverse reaction to aspirin or a COX inhibitor.
Stable asthma (post-bronchodilator FEV1 of 70% or better, no increase in baseline dose of oral glucocorticoids for at least 3 months, and no history of hospitalization or emergency room visits for asthma for at least the prior 6 months).
No current smoking
Non-pregnant

Inclusion Criteria for Non Asthmatics with Allergic Rhinitis:

No history of physician-diagnosed asthma.
No current nasal polyposis confirmed by nasal examination.
No history of any adverse reaction to aspirin or a COX inhibitor.
No current smoking
Non-pregnant
Clinical history of symptoms consistent with allergic rhinitis and previously documented allergy to at least one environmental,immunoglobulin E (IgE) testing).
Normal lung function (baseline FEV1 of 80% of predicted or better).
A score of 4 or below on the Asthma Screening Questionnaire (33) and negative responses to asthma history questions

Exclusion Criteria for participants with AERD:

Current breastfeeding
History of bleeding diathesis or current use of anticoagulant or antiplatelet drugs
Hypersensitivity to montelukast or thienopyridines
History of peptic ulcer disease or gastrointestinal bleed
Current severe gastro-esophageal reflux disease (GERD), defined as patient currently requiring more than 2 total doses of medication per day to treat persistent symptoms: either more than 2 doses of any single medication type (antacid, proton pump inhibitor, or H2 receptor antagonist), or more than 2 types of medication per day to treat symptoms
History of systemic or life-threatening respiratory reaction to aspirin requiring intubation or administration of adrenalin
Current use of any oral beta blocker (due to the risk of bronchospasm associated with beta blockers).
History of transient ischemic attack or stroke, or diabetes.
Current presence of uncontrolled hypertension.
History of hepatic impairment or alcoholism, or evidence of abnormal liver function at Screening Visit. Aspartate transaminase (AST) and alanine transaminase (ALT) levels may not exceed 1.5x the upper limit of normal at Screening Visit (AST may not exceed 52 IU/L, ALT may not exceed 78 IU/L).

Exclusion Criteria for Participants with Aspirin Tolerant Asthma and Non Asthmatics with Allergic Rhinitis:

Current breastfeeding
History of bleeding diathesis or current use of anticoagulant or antiplatelet drugs
Hypersensitivity to montelukast or thienopyridines
History of peptic ulcer disease or gastrointestinal bleed
Current severe GERD
Current use of any oral beta blocker.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01597375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.