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Inflammatory subtypes in asthma.

Inflammatory subtypes in asthma.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26030
Enrollment
40
Registered
2010-06-08
Start date
2010-07-01
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

Asthma

Interventions

1. Lungfunction
2. Sputum induction
3. Collection of exhaled air
4. Blood withdrawal
5. Nasal lavage
6. Collection of urine.

Sponsors

Academisch Medisch Centrum (AMC) Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >18 years; 2. Clinical presentation of asthma; 3. Airway hyperresponsiveness, indicated by a positive methacholine challenge with PC20  8 mg/ml OR; 4. Reversibility in FEV1 of ≥ 12% predicted; 5. Requiring inhaled corticosteroids at high doses (≥ 500 ug ICS fluticasone or equivalent); 6. Non-smoking or stopped smoking more than 12 months ago and 10 pack years or less; 7. No condition or treatment which may increase the risk of bleeding; 8. No other clinically significant abnormality on history and clinical examination; 9. Able to give written and dated informed consent prior to any study-specific procedures.

Exclusion criteria

Exclusion criteria: 1. Change in the dose of ICS in 4 weeks prior to screening; 2. A course of oral corticosteroids, antibiotics or a respiratory infection within 4 weeks prior to the study; 3. Use of anti-leukotrienes, chromoglycates, anti-cholinergics within 4 weeks prior to the study; 4. Pregnancy; 5. 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; 6. Unwillingness or inability to comply with the study protocol for any other reason.

Design outcomes

Primary

MeasureTime frame
eNose breathprint of eosinophilic and non-eosinophilic astma.

Secondary

MeasureTime frame
Individual biomarkers and proteomic profiles in sputum, blood, urine, and nasal lavage, associated with eosinophilic asthma and non-eosinophilic asthma.

Contacts

Public ContactA.H. Wagener

Meibergdreef 9

A.H.Wagener@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)