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Aspirin provocation of patients with Systemic Mastocytosis

Aspirin provocation of patients with Systemic Mastocytosis - Provocation trial

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43428
Enrollment
50
Registered
2016-07-06
Start date
2016-08-01
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Interventions

Provocation with ASA 1 day of 4 hours, patients will receive three placebo tablets 1 day of 4 hours, subjects will receive ASA in three ascending dosages

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Systemic mastocytosis, according to WHO criteria.

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
- frequency of allergic reactions due to ASA ingestion - severity of anaphylaxis: grading of symptoms

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)