A study to investigate the effect of inhaled and intranasal pathogens on pro-infammatory markers using (existing) techniques in order to acquire experience with these techniques.
Recruiting
- Conditions
- Asthma, COPDAstma, COPD
- Registration Number
- NL-OMON26578
- Lead Sponsor
- QPS Netherlands B.V.QPS Netherlands BVPetrus Campersingel 1239713 AGGroningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Healthy Male/Female subjects, aged 18-55 yrs (inclusive);
2. FVC, FEV1 80% ; FEV1/FVC ratio 0.75;
Exclusion Criteria
1. History of upper and lower airway infection <4 wks;
2. Relevant atopy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Cellular fraction endpoints, for evaluation of total and differential cell count (analyzable sputum);<br /><br>2. Sputum inflammatory cell response (i.e., number of neutrophils; responders<br>versus non-responders; response defined as an absolute rise in sputum neutrophil counts of at least 10% from pre-challenge evaluation;<br /><br>3. Soluble fraction (supernatant) endpoints, to be frozen pending analysis. Used<br>analyses technique examples are: ELISA, RIA, Luminax for the detection of<br>soluble inflammatory biomarkers including cytokines and mediators Including, but<br>not limited to e.g. interleukin (IL)-8, TNF-alpha, leakage markers (e.g., alpha2-<br>macroglobulin).
- Secondary Outcome Measures
Name Time Method 1. FEV1, to assess bronchoconstriction;<br /><br>2. Pulsoximetry to assess peripheral oxygen saturation;<br /><br>3. Vital signs (blood pressure, heart rate, body temperature), and adverse events (in case they occur).