Aspirin provocation of patients with Systemic Mastocytosis

Withdrawn

• Conditions: Allergy; systemic mastocytosis; 10001708

• Registration Number: NL-OMON43428
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Systemic mastocytosis, according to WHO criteria.

Exclusion Criteria

Severe of uncontrolled asthma (FEV1<70%), nasal polyps, chronic rhinosinusitis, previous anaphylaxis due to NSAID's, patients who are not able to provide follow-up information, patients who are not deemed capable of handling possible delayed anaphylaxis at home.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- frequency of allergic reactions due to ASA ingestion<br /><br>- severity of anaphylaxis: grading of symptoms</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- measurment of mast cell mediators before and after ASA ingestion; serum<br /><br>trypase levels, plasma 11bèta-PGF2a levels, urine leukotriene E4 levels and<br /><br>urine N-methylhistamine levels.<br /><br>- daily SM-related symptoms: information will be retrieved with questionnaires.<br /><br>- measurement of health-related quality of life of SM patients.</p><br>