Research with human participants

Overview of medical research in the Netherlands

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.

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Last updated:

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Bronchial disorders (excl neoplasms)
Study type
Interventional

ID

NL-OMON36988

Source

ToetsingOnline

Brief title

125633-CS-00186

Condition

  • Bronchial disorders (excl neoplasms)

Synonym

Asthma, COPD

Research involving

Human

Sponsors and support

Primary sponsor :
QPS Netherlands B.V.
Source(s) of monetary or material Support :
QPS Netherlands B.V.

Intervention

Keyword :
healthy subjects, LPS, phase 0, sputum induction

Outcome measures

Primary outcome

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Secondary outcome

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Background summary

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Study objective

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Study design

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Intervention

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Study burden and risks

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Public
QPS Netherlands B.V.

Hanzeplein 1, Entrance 53
Groningen 9713 GZ
NL
Scientific
QPS Netherlands B.V.

Hanzeplein 1, Entrance 53
Groningen 9713 GZ
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

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.

Design

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
10
Type :
Anticipated

Approved WMO
Date :
Application type :
First submission
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

ID: 26578
Source: Nationaal Trial Register
Title: 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.

In other registers

Register ID
CCMO NL41617.056.12
OMON NL-OMON26578