Responsivity and reproducibility of messenger and micro RNA airway inflammatory markers - a pilot study

Completed

Conditions: COPD
10006436

Registration Number: NL-OMON50575

Lead Sponsor: ongziekten

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age >40 years at recruitment
- COPD patients with an FEV1/FVC < 0.7
- Diagnosis of moderate or severe COPD exacerbation
- FEV1 > 0.8 L and ability to produce sputum after hypertonic saline production
- A smoking history of >10 pack years

Exclusion Criteria

- Acute pneumonia as determined by X-ray
- > 48 h intake of prednisolon/antibiotics
- Need for mechanical ventilation (either invasive or non-invasive)
- Treatment with immune-modulating agents for any disease
- Experimental interventions for COPD last half year
- Former/concomitant diagnosis of asthma
- Any significant other pulmonary disease or disorder
- Existing pregnancy/ current willingness for becoming pregnant

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints of induced sputum samples:<br /><br>The main parameters of induced sputum samples will be mRNA level expression of<br /><br>IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta.<br /><br><br /><br>Primary endpoints of nose mucosa samples:<br /><br>The main parameters of nose mucosa samples will be mRNA and miRNA level<br /><br>expression of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta.<br /><br><br /><br>Therefore, three consecutive sputum inductions and nasal brush extractions will<br /><br>take place in a 7 week period.<br /><br>The obtained data from Visit 1 and 2 will used to analyze the responsivity of<br /><br>these inflammatory markers during a marked change in inflammatory state. The<br /><br>obtained data from Visit 2 and 3 will be used for the analysis of<br /><br>reproducibility of these inflammatory markers. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following parameters will be investigated for our secondary objectives in<br /><br>induced sputum of COPD patients:<br /><br><br /><br>- Inflammation cell profiles<br /><br>- LTB4 levels<br /><br>- protein levels of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta, ECP and<br /><br>TGF-beta</p><br>