Aspirin provocation of patients with Systemic Mastocytosis

Aspirin provocation of patients with Systemic Mastocytosis - Provocation trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45671

Enrollment

Registered

2017-02-17

Start date

2017-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Allergy

Interventions

Double blind, placebo controlled provocation with aspirin.

acetylsalicylic acid

anaphylaxis

Mastocytosis

NSAID

Eligibility

Age

18 Years to 64 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

Measure	Time frame
The frequency and severity of allergic reactions to aspirin.	—

Secondary

Measure	Time frame
- the influence of aspirin on mast cell mediators; e.g. measurement of serum tryptase and 11bèta-PGF2 levels and of urine leukotriene E4 and N-methylhistamine levels - daily SM-related symptoms and quality of life (questionnaires)	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)