Idiopathic Pulmonary FibrosisVACFINCT01777373
Conducting Airways in Lung Fibrosis (VACFI)
An observational study of Idiopathic Pulmonary Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 141 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18-85 years
- IPF diagnosed according to ATS/ERS/JRS/ALAT criteria
- Patient gave informed consent
- NON INCLUSION CRITERIA
- Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema, tuberculosis sequelae, prior lung surgery
- Obstructive ventilatory disorder
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- Counterindication to pulmonary function testing
- Women : Pregnancy or milking
- Lack of health insurance
- Controls :
- Volunteers aged 18-85 years, free of any respiratory disease
- Volunteer gave informed consent
- Secondary EXCLUSION CRITERIA Abnormal PFT : Total lung capacity or FEV1/VC ratio < Lower Limit of Normal
- Non-IPF ILD :
- Age 18-85 years
- Radiological interstitial pneumonia, on 2 tests performed >3 months apart
- PINS histology OR sarcoidosis histology OR clinical diagnosis of drug-induced lung disease OR diagnosis of auto-immune disease
- Patient gave informed consent
- NON INCLUSION CRITERIA
- Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema, tuberculosis sequelae, prior lung surgery
- Obstructive ventilatory disorder
- Counterindication to pulmonary function testing
- Women : Pregnancy or milking
- Lack of health insurance
- Uncharacterized ILD :
- Age 18-85 years
- Radiological interstitial pneumonia, on 2 tests performed >3 months apart
- Patient gave informed consent
- NON INCLUSION CRITERIA
- Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema, tuberculosis sequelae, prior lung surgery
- Obstructive ventilatory disorder
- Counterindication to pulmonary function testing
- Women : Pregnancy or milking
- Lack of health insurance
- Secondary EXCLUSION CRITERIA Final diagnosis other than either IPF or non-IPF interstitial pneumonia.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conducting Airways in Lung Fibrosis
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.
Read the 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
- Keywords
- conducting airway, bronchiolization
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fowler dead space
Conducting airway volume is determined by Fowler's method from volumetric capnography data
Measured: 1 day
Secondary outcomes (1)
Bohr anatomic dead space
Bohr anatomic dead space is determined from capnography and spirometry data.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent PLANTIER, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777373
- Sponsor's protocol ID
- P110902
- Other IDs
- N° IDRCB : 2012-A00295-38
- Acronym
- VACFI
- Status last verified
- Dec 2014
- First submitted
- 2 Oct 2012
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conducting Airways in Lung Fibrosis
- ClinicalTrials.gov ID
- NCT01777373
- Acronym / sponsor ID
- VACFI / P110902
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- conducting airway, bronchiolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (35 listed)
- Age 18-85 years
- IPF diagnosed according to ATS/ERS/JRS/ALAT criteria
- Patient gave informed consent
- NON INCLUSION CRITERIA
- Presence of respiratory comorbidities : Asthma, COPD, bronchiectasis, emphysema, tuberculosis sequelae, prior lung surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fowler dead space
Time frame: 1 day
Conducting airway volume is determined by Fowler's method from volumetric capnography data
1 secondary outcome
Bohr anatomic dead space
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent PLANTIER, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fowler dead space (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.