Effect of Anti-Inflammatory Agents on Biological Responses to Endotoxin Inhalation in Healthy Subjects
- Sponsor
- Brugmann University Hospital
- Study ID
- NCT02252809
- Phase
- EARLY_PHASE1
- Status
- Completed
Conditions
- Innate Immunity
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 49 Years
- Healthy Volunteers
- Accepted
Interventions
- adalimumab — DRUG
- methylprednisolone — DRUG
Study Details
The main objective of this study is to characterize the biological responses elicited by endotoxin inhalation applied to healthy subjects, and to assess the effect of standard anti-inflammatory agents (i.e. adalimumab and methylprednisolone) on these biological responses.
Key Dates
- Start date
- Nov 30, 2008
- Status verified
- Sep 2014
- Primary completion
- Apr 30, 2009
- Completion
- Jul 31, 2009
Study Design
- Enrollment
- 51 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Active Comparator: adalimumabadalimumab 40 mg by subcutaneous way 7 days before endotoxin inhalation
- Active Comparator: methylprednisolonemethylprednisolone 20 mg daily , 7 days before endotoxin inhalation
- No Intervention: controlno intervention, 7 days before endotoxin inhalation
Primary Outcome Measure
sputum cells count [ Time Frame: 7 days ]