Conducting Airways in Lung Fibrosis (VACFI)

NCT ID: NCT01777373

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 141 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-02-28

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Idiopathic pulmonary fibrosis (IPF)

Idiopathic pulmonary fibrosis (IPF)

No interventions assigned to this group

Control

Control

No interventions assigned to this group

Non-IPF interstitial lung disease (ILD)

Non-IPF interstitial lung disease (ILD)

No interventions assigned to this group

Uncharacterized ILD

Uncharacterized ILD

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age 18-85 years

2. IPF diagnosed according to ATS/ERS/JRS/ALAT criteria

3. Patient gave informed consent

1. Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema, tuberculosis sequelae, prior lung surgery

2. Obstructive ventilatory disorder

3. Counterindication to pulmonary function testing

4. Women : Pregnancy or milking

5. Lack of health insurance

Controls :

1. Volunteers aged 18-85 years, free of any respiratory disease

2. Volunteer gave informed consent

1. Age 18-85 years

2. Radiological interstitial pneumonia, on 2 tests performed >3 months apart

3. PINS histology OR sarcoidosis histology OR clinical diagnosis of drug-induced lung disease OR diagnosis of auto-immune disease

4. Patient gave informed consent

1. Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema, tuberculosis sequelae, prior lung surgery

2. Obstructive ventilatory disorder

3. Counterindication to pulmonary function testing

4. Women : Pregnancy or milking

5. Lack of health insurance

Uncharacterized ILD :

1. Age 18-85 years

2. Radiological interstitial pneumonia, on 2 tests performed >3 months apart

3. Patient gave informed consent

1. Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema, tuberculosis sequelae, prior lung surgery

2. Obstructive ventilatory disorder

3. Counterindication to pulmonary function testing

4. Women : Pregnancy or milking

5. Lack of health insurance

Exclusion Criteria

Non-IPF ILD :

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent PLANTIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bichat

Paris, , France

Countries

France

Other Identifiers

N° IDRCB : 2012-A00295-38

Identifier Type: OTHER

Identifier Source: secondary_id

P110902

Identifier Type: -

Identifier Source: org_study_id