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Infections in Stable Asthmatic Patients: Non Invasive Detectio

Conditions
Asthma
10024970
Registration Number
NL-OMON31432
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
45
Inclusion Criteria

- Men and/or women age between 18-65 years
- History of episodic chest tightness and wheezing (for the MILD and SEVERE astmatic patients)
- Prebronchodilator FEV 1 *80% predicted (for the MILD asthmatic patients)
- Reversibility in FEV1>12% predicted, or documented hyperesponsiveness (PC20 methacoline < 4mg/ml) during the past 12 months.
- Steroid-naïve (for the MILD asthmatic patients)
- Non smoking or ex-smokers (stopped more than 12 months ago and 5 pack year or less).
- Proven skin prick test. (for the MILD asthmatic patients)
- Use of high doses of inhaled corticosteroids (* 1000 µg/day beclomethasone or equivalent) and long acting bronchodilators for more than 12 months. (for the SEVERE athmatic patients)
- One severe asthma exacerbation requiring oral steroid therapy during the past 12 months. (for the SEVERE athmatic patients)
- Baseline FEV1*75% of predicted or negative documented airway hyperresponsiveness (PC20 methacoline>8mg/ml) (for the HEALTHY subjects)
- Negative history of pulmonary and any other relevant diseases. (for the HEALTHY subjects)

Exclusion Criteria

- History of current alcohol or drug abuse, as judged by the investigator.
- Subjects who have had an exacerbation or a chest infection within the last 4 weeks prior to the study.
- Uncontrolled hypertension-systolic blood pressure(BP)>200 mmHg and/or diastolic BP>100 mmHg.
- Concomitant disease or condition which could 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

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The first aim of the study is to determine the prevalence of latent infections<br /><br>by non invasive assessment of induced sputum, exhaled breath condensate and<br /><br>nasal/throat swabs in stable asthmatic patients and controls. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The severity of airway inflammation based on sputum cell differentials</p><br>
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