BENEFIT study

Recruiting

• Conditions: IPF; Idiopathic pulmonary fibrosis; interstitial lung disease; lung fibrosisLongfibrose; interstitiele longziektenTNF-alpha; anti-TNF-alpha antibodies

• Registration Number: NL-OMON27093
• Lead Sponsor: Investigator's initiated study performed by BENEFIT study group

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1. Diagnosis of IPF(2):

a) If possible a thoracoscopic or open lung biopsy showing UIP. A thoracoscopic or open lung biopsy must be performed in patients <51 years old. Transbronchial biopsy is strongly advocated and should show no features to support an alternate diagnosis.

Exclusion Criteria

1. Critical low lung function: FVC < 50%.

2. Artificially ventilated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in FVC from baseline<br /><br>Time to disease progression (ATS criteria)

Secondary Outcome Measures

Name	Time	Method
Cytokines <br /><br>-BAL: pro-inflammatory and pro-fibrotic cytokines; growth factors; MMP's; surface (activation) markers on resident cells <br /><br>- Serum:pro-inflammatory and pro-fibrotic cytokines; growth factors; MMP's; surface markers on resident cells <br /><br>- Blood: surface (activation) markers on white blood cells<br /><br><br /><br>Clinical secondary endpoints<br /><br>- Six minute walk distance (6-MWD)<br /><br>- Borg dyspnea score after 6-MWT<br /><br>- Difference in O2 saturation and heart rate before and after 6-MWT<br /><br>- PO2 and p(A-a)O2 at rest and room air<br /><br>- HRCT: fibrosis and groundglass <br /><br>Lung function (FVC,TLC,RV,DLco)