Exhaled Markers in Asthma during Inhaled steroid Lowering

Completed

Conditions: Asthma
exacerbatie
10006436

Registration Number: NL-OMON35841

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Age: at least 18 years.
- Mild to moderately severe persistent asthma according to the GINA criteria.
- Using at least a daily dose of inhaled corticosteroids (* 500 ug ICS fluticasone or equivalent).
- Controlled or partly controlled asthma according to the criteria by GINA.
- Exacerbations: one or more in the past 2 years.
- Non-smoking or stopped smoking more than 12 months ago and a total maximum of 5 pack years.
- No other clinically significant abnormality on history and clinical examination.
- Able to give written and dated informed consent prior to any study-specific procedures.

Exclusion Criteria

- Change in the dose of inhaled corticosteroids within 4 weeks prior to screening.
- A course of oral corticosteroids, antibiotics or a respiratory infection within 4 weeks prior to the study.
- Use of ipratropium, anti-IgE or oral corticosteroids.
- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in eNose breathprint at loss of control compared to stable condition,<br /><br>after completion of 8 weeks steroid withdrawal phase. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Individual biomarkers in sputum, blood ann exhaled breath condensate (EBC)<br /><br>that are associated with asthma control and with electronic nose ann GC-MS<br /><br>breathprints.<br /><br>2. Hemostatic activity.</p><br>