Usual Interstitial PneumoniaDm&VcNCT02596841
Lung Diffusing Capacity for Nitric Oxide as a Marker of Fibrotic Changes in Idiopathic Interstitial Pneumonias
An observational study of Usual Interstitial Pneumonia and Nonspecific Interstitial Pneumonia, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
Trial summary
The diagnosis of idiopathic interstitial pneumonia (IIP) is based on computed tomography (CT) imaging, whereas lung function studies are used for staging and follow up. Lung diffusing capacity for carbon monoxide (DLCO) is generally reduced but weakly correlated with the severity of CT-determined fibrotic process. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Usual Interstitial Pneumonia, Nonspecific Interstitial Pneumonia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators used retrospectively collected data of 60 Caucasian patients with clinical and radiological features of Idiopathic Interstitial Pneumonias referred to Respiratory Pathophysiology Unit for a complete pulmonary function evaluation.
Who may be able to join
- Chest computed tomography (CT) scan diagnosis of either usual interstitial pneumonia-idiopathic pulmonary fibrosis (UIP-IPF) or idiopathic nonspecific interstitial pneumonia (NSIP)
Who cannot join
- Symptoms/signs or specific serum markers of an underlying autoimmune process
- Previous environmental/occupational exposure to fibrogenic dusts
- Use of fibrogenic medications
About this study
The diagnosis of idiopathic interstitial pneumonia (IIP) is based on computed tomography (CT) imaging, whereas lung function studies are used for staging and follow up. Lung diffusing capacity for carbon monoxide (DLCO) is generally reduced but weakly correlated with the severity of CT-determined fibrotic process. A possible explanation of this finding is that DLCO is relatively insensitive to changes in alveolar membrane diffusive conductance (DMCO). Lung diffusion capacity for nitric oxide (DLNO) was strongly correlated with CT-determined amount of fibrosis/honeycombing in both usual and non-specific interstitial pneumonias. Moreover. Both DLNO and DMCO were below the lower limit of normality even in patients with small amount of fibrosis. Measurement of DLNO may provide a more reliable assessment of fibrotic changes than DLCO because it better reflects DMCO.
Read the detailed description
Rationale: Lung diffusing capacity for carbon monoxide (DLCO) is decreased in both usual interstitial pneumonia-idiopathic pulmonary fibrosis (UIP-IPF) and nonspecific interstitial pneumonia (NSIP), but is weakly related to computed tomography (CT)-determined fibrotic changes.
Objectives: To determine whether measurement of lung diffusing capacity for nitric oxide (DLNO) better reflects fibrotic changes than DLCO.
Methods: DLNO and DLCO were measured simultaneously in 30 patients with UIP-IPF and 30 with NSIP. The amount of pulmonary fibrosis was estimated by volumetric analysis of visually bounded areas showing reticular opacities and honeycombing. Alveolar membrane conductance (DMCO) and pulmonary capillary volume (Vc) were calculated.
- Keywords
- Lung diffusing capacity, Idiopathic Interstitial Pneumonias
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Idiopathic Interstitial Pneumonias
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of lung diffusing capacity for nitric oxide (DLNO) in a group of 60 patients with fibrosing idiopathic interstitial pneumonias (IIPs)
Because DLNO is more sensitive to alveolar membrane diffusive conductance (DMCO) than standard lung diffusing capacity for carbon monoxide, DLNO changes may better reflect the extent of fibrotic process in IIPs
Measured: Within 1 month following idiopathic interstitial pneumonias diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Usual Interstitial PneumoniaStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Barisione, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596841
- Sponsor's protocol ID
- IRCCS 2015
- Acronym
- Dm&Vc
- Status last verified
- Nov 2015
- First submitted
- 29 Oct 2015
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Guenard H, Varene N, Vaida P. Determination of lung capillary blood volume and membrane diffusing capacity in man by the measurements of NO and CO transfer. Respir Physiol. 1987 Oct;70(1):113-20. doi: 10.1016/s0034-5687(87)80036-1.
PubMed 3659606Borland CD, Higenbottam TW. A simultaneous single breath measurement of pulmonary diffusing capacity with nitric oxide and carbon monoxide. Eur Respir J. 1989 Jan;2(1):56-63.
PubMed 2707403Wemeau-Stervinou L, Perez T, Murphy C, Polge AS, Wallaert B. Lung capillary blood volume and membrane diffusion in idiopathic interstitial pneumonia. Respir Med. 2012 Apr;106(4):564-70. doi: 10.1016/j.rmed.2011.12.011. Epub 2012 Jan 4.
PubMed 22221584Barisione G, Brusasco C, Garlaschi A, Baroffio M, Brusasco V. Lung diffusing capacity for nitric oxide as a marker of fibrotic changes in idiopathic interstitial pneumonias. J Appl Physiol (1985). 2016 May 1;120(9):1029-38. doi: 10.1152/japplphysiol.00964.2015. Epub 2016 Feb 18.
PubMed 26893034
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Diffusing Capacity for Nitric Oxide as a Marker of Fibrotic Changes in Idiopathic Interstitial Pneumonias
- ClinicalTrials.gov ID
- NCT02596841
- Acronym / sponsor ID
- Dm&Vc / IRCCS 2015
- Keywords
- Lung diffusing capacity, Idiopathic Interstitial Pneumonias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Nov 2015 (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 diagnosis of idiopathic interstitial pneumonia (IIP) is based on computed tomography (CT) imaging, whereas lung function studies are used for staging and follow up. Lung diffusing capacity for carbon monoxide (DLCO) is generally reduced but weakly correlated with the severity of CT-determined fibrotic process. A possible explanation of this finding is that DLCO is relatively insensitive to changes in alveolar membrane diffusive conductance (DMCO). Lung diffusion capacity for nitric oxide (DLNO) was strongly correlated with CT-determined amount of fibrosis/honeycombing in both usual and non-specific interstitial pneumonias. Moreover. Both DLNO and DMCO were below the lower limit of normality even in patients with small amount of fibrosis. Measurement of DLNO may provide a more reliable assessment of fibrotic changes than DLCO because it better reflects DMCO.
Detailed description
Rationale: Lung diffusing capacity for carbon monoxide (DLCO) is decreased in both usual interstitial pneumonia-idiopathic pulmonary fibrosis (UIP-IPF) and nonspecific interstitial pneumonia (NSIP), but is weakly related to computed tomography (CT)-determined fibrotic changes.
Objectives: To determine whether measurement of lung diffusing capacity for nitric oxide (DLNO) better reflects fibrotic changes than DLCO.
Methods: DLNO and DLCO were measured simultaneously in 30 patients with UIP-IPF and 30 with NSIP. The amount of pulmonary fibrosis was estimated by volumetric analysis of visually bounded areas showing reticular opacities and honeycombing. Alveolar membrane conductance (DMCO) and pulmonary capillary volume (Vc) were calculated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators used retrospectively collected data of 60 Caucasian patients with clinical and radiological features of Idiopathic Interstitial Pneumonias referred to Respiratory Pathophysiology Unit for a complete pulmonary function evaluation.
Key inclusion criteria (1 listed)
- Chest computed tomography (CT) scan diagnosis of either usual interstitial pneumonia-idiopathic pulmonary fibrosis (UIP-IPF) or idiopathic nonspecific interstitial pneumonia (NSIP)
Key exclusion criteria (3 listed)
- Symptoms/signs or specific serum markers of an underlying autoimmune process
- Previous environmental/occupational exposure to fibrogenic dusts
- Use of fibrogenic medications
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
Changes of lung diffusing capacity for nitric oxide (DLNO) in a group of 60 patients with fibrosing idiopathic interstitial pneumonias (IIPs)
Time frame: Within 1 month following idiopathic interstitial pneumonias diagnosis
Because DLNO is more sensitive to alveolar membrane diffusive conductance (DMCO) than standard lung diffusing capacity for carbon monoxide, DLNO changes may better reflect the extent of fibrotic process in IIPs
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 4 Nov 2015.
- Background: PubMed 3659606Guenard H, Varene N, Vaida P. Determination of lung capillary blood volume and membrane diffusing capacity in man by the measurements of NO and CO transfer. Respir Physiol. 1987 Oct;70(1):113-20. doi: 10.1016/s0034-5687(87)80036-1.
- Background: PubMed 2707403Borland CD, Higenbottam TW. A simultaneous single breath measurement of pulmonary diffusing capacity with nitric oxide and carbon monoxide. Eur Respir J. 1989 Jan;2(1):56-63.
- Background: PubMed 22221584Wemeau-Stervinou L, Perez T, Murphy C, Polge AS, Wallaert B. Lung capillary blood volume and membrane diffusion in idiopathic interstitial pneumonia. Respir Med. 2012 Apr;106(4):564-70. doi: 10.1016/j.rmed.2011.12.011. Epub 2012 Jan 4.
- Derived from this study: PubMed 26893034Barisione G, Brusasco C, Garlaschi A, Baroffio M, Brusasco V. Lung diffusing capacity for nitric oxide as a marker of fibrotic changes in idiopathic interstitial pneumonias. J Appl Physiol (1985). 2016 May 1;120(9):1029-38. doi: 10.1152/japplphysiol.00964.2015. Epub 2016 Feb 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Usual Interstitial Pneumonia and Nonspecific Interstitial Pneumonia, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
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 1 inclusion and 3 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 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes of lung diffusing capacity for nitric oxide (DLNO) in a group of 60 patients with fibrosing idiopathic interstitial pneumonias (IIPs) (time frame: Within 1 month following idiopathic interstitial pneumonias diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596841, which also lists 4 linked publications.
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 4 Nov 2015.