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Fingerprints for inflammatory subtypes in asthma

Fingerprints for inflammatory subtypes in asthma - Inflammatory subtypes in asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34697
Enrollment
40
Registered
2010-03-03
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

asthma chronic inflammation of the airways

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age >18 years * Clinical presentation of asthma * Airway hyperresponsiveness, indicated by a positive methacholine challenge with PC20 * 8 mg/ml OR * reversibility in FEV1 of * 12% predicted * Requiring inhaled corticosteroids at high doses (* 500 ug ICS fluticasone or equivalent) * Non-smoking or stopped smoking more than 12 months ago and 10 pack years or less * No condition or treatment which may increase the risk of bleeding * No other clinically significant abnormality on history and clinical examination * Able to give written and dated informed consent prior to any study-specific procedures - sputum eosinophils > 3% * eosinophilic asthma - sputum eosinophils

Exclusion criteria

Exclusion criteria: * Change in the dose of ICS in 4 weeks prior to screening * A course of oral corticosteroids, antibiotics or a respiratory infection within 4 weeks prior to the study * Use of anti-leukotrienes, chromoglycates, anti-cholinergics within 4 weeks prior to the study * Pregnancy * Concomitant disease or condition which could interfere with the conduct of the study, or which treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study * Unwillingness or inability to comply with the study protocol for any other reason

Design outcomes

Primary

MeasureTime frame
eNose breathprints of eosinophilic and non-eosinophilic asthmatic subjects.

Secondary

MeasureTime frame
* Specific molecular components that are associated with eosinophilic and non-eosinophilic asthma as determined by gas-chromatography and mass-spectrometry * Individual biomarkers and proteomic profiles in sputum, blood, urine, nasal lavage and nasal biopsies predictive for eosinophilic and non-eosinophilic asthma

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)