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Conducting Airways in Lung Fibrosis (VACFI) (VACFI)

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ClinicalTrials.gov Identifier: NCT01777373
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date October 2, 2012
First Posted Date January 28, 2013
Last Update Posted Date April 10, 2015
Study Start Date August 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2013)
Fowler dead space [ Time Frame: 1 day ]
Conducting airway volume is determined by Fowler's method from volumetric capnography data
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01777373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 23, 2013)
Bohr anatomic dead space [ Time Frame: 1 day ]
Bohr anatomic dead space is determined from capnography and spirometry data.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Conducting Airways in Lung Fibrosis (VACFI)
Official Title Conducting Airways in Lung Fibrosis
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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Idiopathic Pulmonary Fibrosis
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 23, 2013)
141
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01777373
Other Study ID Numbers P110902
N° IDRCB : 2012-A00295-38 ( Other Identifier: AFSSAPS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Laurent PLANTIER, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2014