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Conducting Airways in Lung Fibrosis (VACFI)

This study is currently recruiting participants.
Verified January 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01777373
First received: October 2, 2012
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Idiopathic Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Conducting Airways in Lung Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Fowler dead space [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Conducting airway volume is determined by Fowler's method from volumetric capnography data


Secondary Outcome Measures:
  • Bohr anatomic dead space [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Bohr anatomic dead space is determined from capnography and spirometry data.


Estimated Enrollment: 141
Study Start Date: August 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Idiopathic pulmonary fibrosis (IPF)
Idiopathic pulmonary fibrosis (IPF)
Control
Control
Non-IPF interstitial lung disease (ILD)
Non-IPF interstitial lung disease (ILD)
Uncharacterized ILD
Uncharacterized ILD

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

IPF will be diagnosed according to ATS/ERS/JRS/ALAT 2012 guidelines, either in the presence of a typical Usual Interstitial Pneumonia pattern on CT imaging of the lung or in the presence of a probable UIP pattern on a pathological lung specimen, and in the absence of any identified cause of secondary interstitial pneumonia.

Patients with non-IPF interstitial pneumonias will be recruited. Due to the case mix at Bichat and Pompidou hospitals, patients with idiopathic Non Specific Interstitial Pneumonia and interstitial pneumonia associated with sarcoidosis and auto-immune disease will be recruited.

In some patients, a definitive diagnosis of either IPF or non-IPF interstitial pneumonia will not be available at the time of inclusion.

Criteria

IPF :

INCLUSION CRITERIA

  1. Age 18-85 years
  2. IPF diagnosed according to ATS/ERS/JRS/ALAT criteria
  3. Patient gave informed consent

NON INCLUSION CRITERIA

  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 :

INCLUSION CRITERIA

  1. Volunteers aged 18-85 years, free of any respiratory disease
  2. Volunteer gave informed consent

Secondary EXCLUSION CRITERIA Abnormal PFT : Total lung capacity or FEV1/VC ratio < Lower Limit of Normal

Non-IPF ILD :

INCLUSION CRITERIA

  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

NON INCLUSION CRITERIA

  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 :

INCLUSION CRITERIA

  1. Age 18-85 years
  2. Radiological interstitial pneumonia, on 2 tests performed >3 months apart
  3. Patient gave informed consent

NON INCLUSION CRITERIA

  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

Secondary EXCLUSION CRITERIA Final diagnosis other than either IPF or non-IPF interstitial pneumonia.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777373

Contacts
Contact: Laurent PLANTIER, MD, PhD 33 1 40 25 84 06 laurent.plantier@bch.aphp.fr
Contact: Christophe DELCLAUX, MD, PhD christophe.delclaux@egp.aphp.fr

Locations
France
Hôpital Bichat Recruiting
Paris, France, 75018
Contact: Laurent PLANTIER, MD, PhD     33 1 40 25 84 06     laurent.plantier@bch.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent PLANTIER, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01777373     History of Changes
Other Study ID Numbers: P110902, N° IDRCB : 2012-A00295-38
Study First Received: October 2, 2012
Last Updated: January 23, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
conducting airway, bronchiolization

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 23, 2013