Conducting Airways in Lung Fibrosis (VACFI)

Completed

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT01777373
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The purpose of this study is to determine whether extension of the conducting airways into the distal lung, or bronchiolization, occurs early in the course of Idiopathic Pulmonary Fibrosis, a disease wherein normal lung structures are destroyed and replaced by non-functional scar tissue.

Detailed Description

Diffuse Interstitial Pneumonias are a heterogeneous group of chronic respiratory diseases. Idiopathic Pulmonary Fibrosis, one of such diseases, is characterized by lesions of the conducting airways including extension of bronchioles towards the distal lung, or bronchiolization of the distal lung. Such lesions are traditionally referred to as "traction bronchiectasis" although no evidence supports a cause-and-effect relationship between alveolar fibrosis and airway lesions. Another feature of IPF is chronic, invalidating dry cough. Our hypothesis is that IPF is characterized by early increases in the volume of conducting airways, that such changes correlate with cough, and that airway changes are in direct relation with airway fibrosis. The primary aim of this study is to demonstrate increased anatomical dead space (VD), a surrogate for conducting airway volume, in patients with moderate (or early) IPF, in comparison with subjects without any respiratory disease ("non-DIP controls"). The secondary aims are : To show that VD is increased in patients with IPF in comparison with patients with other DIPs ("DIP controls"), to show that in patients with IPF increased VD does not correlate with indices of alveolar fibrosis, and to show associations between increased VD and cough and other respiratory symptoms in patients with IPF.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Status Verified: 2014-12
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fowler dead space	1 day	Conducting airway volume is determined by Fowler's method from volumetric capnography data

Secondary Outcome Measures

Name	Time	Method
Bohr anatomic dead space	1 day	Bohr anatomic dead space is determined from capnography and spirometry data.

Trial Locations

Locations (1)

Hôpital Bichat; 🇫🇷 Paris, France