Infections in Stable Asthmatic Patients: Non Invasive Detectio
- Conditions
- Asthma10024970
- 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
- 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)
- 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
Name Time Method <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
Name Time Method <p>The severity of airway inflammation based on sputum cell differentials</p><br>