NL-OMON36988CompletedNot Applicable
A phase 0 study to investigate the effects of inhaled and intranasal lipopolysaccharide (LPS) on pro-inflammatory markers sampled by hypertonic saline sputum induction (SI) and nasal lavage (NAL) in healthy subjects. Part 1 with 0,9% NaCl. - 125633-CS-00186
QPS Netherlands B.V.0 sites10 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Healthy M/F subjects, aged 18-55 yrs.
- •- FVC, FEV1 >=80% ; FEV1/FVC ratio >=0.75.
- •- Oxygen saturation >=94% (pulsoximetry).
- •- Normal blood pressure (SBP 90-150, DBP 60-90 mmHg, inclusive) and pulse (45-100 bpm, inclusive)
- •- ECG without clinically relevant abnormalities.
Exclusion Criteria
- •- History of upper and lower airway infection <=4 wks.
- •- Relevant atopy.
- •- Smoker (ex-smoker >1 yr, <10 packyrs).
- •- Positive metacholine inhalation test with a post challenge FEV1 decrease <20% (PC20), <16 mg/ml.
- •- History of clinically relevant pulmonary or cardiovascular disease.
- •- Positive pregnancy test or lactation.
Investigators
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