CopdNCT06613321
Lung Hyperinflation and Response to Pulmonary Vasodilator Therapy
An observational study of Copd and Hypertension, Pulmonary, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Hypertension, Pulmonary, Hyperdistention
- What is being tested?
- Respiratory function tests before introduction of vasodilator therapy and 3 month follow up evaluation of response to treatment.
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to 25 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with pulmonary hypertension associated with COPD undergoing vasodilator therapy at Nancy University Hospital (France) from January 1, 2015 to April 1, 2023.
Who may be able to join
- Patients with COPD regardless of severity defined as a FEV1/FVC ratio less than 0.70 and the presence of a risk factor (smoke exposure with at least a 10 pack-year history, or professional exposition) diagnosed with PH according to ESC/ERS 2022 classification and in whom vasodilator therapy has been initiated
Who cannot join
- other known concomitant lung disease (interstitial lung disease, cystic lung disease, mucoviscidosis…)
- thoracic pathology such as kyphoscoliosis
- pleural effusion (unless part of pulmonary veno-occlusive disease)
- a large tumor lung mass
- EFR missing or uninterpretable because difficult to perform
- initiation of calcium channel blockers
- surgical treatment in chronic thrombo-embolic pulmonary hypertension
- no follow-up evaluation (lost to follow-up or died before reassessment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Lung Hyperinflation on the Response to Pulmonary Vasodilator Therapy in Patients with Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD).
The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).
The study will include all patients from the hospital, followed for pulmonary hypertension associated with COPD under vasodilator therapy between 2015 and 2021.
Read the detailed description
The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).
The study will include all patients from the hospital, followed for PH associated with COPD under vasodilator therapy between 2015 and 2021.
It will evaluate patients' lung hyperinflation according to the RV/TLC ratio and their response to treatment.
- Conditions
- Copd, Hypertension, Pulmonary, Hyperdistention
- Being tested
- Respiratory function tests before introduction of vasodilator therapy, 3 month follow up evaluation of response to treatment.
- Keywords
- copd, pulmonary distension, lung distension disorders, pulmonary hypertension, vasodilator therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory function tests before introduction of vasodilator therapyDiagnostic test
Respiratory function tests before introduction of vasodilator therapy with evaluation of the RV/TLC ratio.
3 month follow up evaluation of response to treatment.Diagnostic test
Follow up of patients at least 3 months after introduction of vasodilator therapy to determine response to treatment or absence of response.
| Study group | Role | What they receive |
|---|---|---|
| Patients with increased lung distension | Defined by a residual volume over total lung capacity ratio (RV/TLC ratio) above the median value of all included patients. Receives: Diagnostic Test: Respiratory function tests before introduction of vasodilator therapy; Diagnostic Test: 3 month follow up evaluation of response to treatment. | |
| Patients without increased distension disorder | Defined by a residual volume over total lung capacity ratio (RV/TLC ratio) below the median value of all included patients. Receives: Diagnostic Test: Respiratory function tests before introduction of vasodilator therapy; Diagnostic Test: 3 month follow up evaluation of response to treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Response to treatment is defined as an improvement of at least 30 meters in the 6-minute walk test or one NYHA functional class at the first re-evaluation performed at least 3 months after the initiation of vasodilator therapy. These criteria will be compared according to the severity of chest distension.
Measured: 3 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Aug 2023
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ari Chaouat, MD PhD, Principal investigator, Université de Lorraine, Département de Pneumologie, CHRU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613321
- Sponsor's protocol ID
- 2023PI014
- Status last verified
- Sep 2024
- First submitted
- 9 Oct 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farkouh C, Chaouat A, Guillaumot A, Baptista BR, Chabot F, Valentin S. Pulmonary hypertension in patients with chronic obstructive pulmonary disease: Impact of lung hyperinflation on the response to pulmonary hypertension treatment. Respir Med Res. 2025 May;87:101153. doi: 10.1016/j.resmer.2024.101153. Epub 2024 Dec 18.
PubMed 39765128
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lung Hyperinflation on the Response to Pulmonary Vasodilator Therapy in Patients with Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT06613321
- Acronym / sponsor ID
- 2023PI014
- Conditions
- Copd, Hypertension, Pulmonary, Hyperdistention
- Keywords
- copd, pulmonary distension, lung distension disorders, pulmonary hypertension, vasodilator therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 25 Sep 2024 (actual)
- 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 goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).
The study will include all patients from the hospital, followed for pulmonary hypertension associated with COPD under vasodilator therapy between 2015 and 2021.
Detailed description
The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).
The study will include all patients from the hospital, followed for PH associated with COPD under vasodilator therapy between 2015 and 2021.
It will evaluate patients' lung hyperinflation according to the RV/TLC ratio and their response to treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with increased lung distension | – | Diagnostic Test: Respiratory function tests before introduction of vasodilator therapy, Diagnostic Test: 3 month follow up evaluation of response to treatment.Defined by a residual volume over total lung capacity ratio (RV/TLC ratio) above the median value of all included patients. |
| Patients without increased distension disorder | – | Diagnostic Test: Respiratory function tests before introduction of vasodilator therapy, Diagnostic Test: 3 month follow up evaluation of response to treatment.Defined by a residual volume over total lung capacity ratio (RV/TLC ratio) below the median value of all included patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with pulmonary hypertension associated with COPD undergoing vasodilator therapy at Nancy University Hospital (France) from January 1, 2015 to April 1, 2023.
Key inclusion criteria (1 listed)
- Patients with COPD regardless of severity defined as a FEV1/FVC ratio less than 0.70 and the presence of a risk factor (smoke exposure with at least a 10 pack-year history, or professional exposition) diagnosed with PH according to ESC/ERS 2022 classification and in whom vasodilator therapy has been initiated
Key exclusion criteria (8 listed)
- other known concomitant lung disease (interstitial lung disease, cystic lung disease, mucoviscidosis…)
- thoracic pathology such as kyphoscoliosis
- pleural effusion (unless part of pulmonary veno-occlusive disease)
- a large tumor lung mass
- EFR missing or uninterpretable because difficult to perform
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory function tests before introduction of vasodilator therapyRespiratory function tests before introduction of vasodilator therapy with evaluation of the RV/TLC ratio. | Diagnostic test | Patients with increased lung distension, Patients without increased distension disorder |
| 3 month follow up evaluation of response to treatment.Follow up of patients at least 3 months after introduction of vasodilator therapy to determine response to treatment or absence of response. | Diagnostic test | Patients with increased lung distension, Patients without increased distension disorder |
Primary outcome
Response to treatment
Time frame: 3 - 12 months
Response to treatment is defined as an improvement of at least 30 meters in the 6-minute walk test or one NYHA functional class at the first re-evaluation performed at least 3 months after the initiation of vasodilator therapy. These criteria will be compared according to the severity of chest distension.
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 25 Sep 2024.
- Derived from this study: PubMed 39765128Farkouh C, Chaouat A, Guillaumot A, Baptista BR, Chabot F, Valentin S. Pulmonary hypertension in patients with chronic obstructive pulmonary disease: Impact of lung hyperinflation on the response to pulmonary hypertension treatment. Respir Med Res. 2025 May;87:101153. doi: 10.1016/j.resmer.2024.101153. Epub 2024 Dec 18.
- Individual participant dataSharing planned: No
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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.
Ari Chaouat, MD PhD principal investigator
Université de Lorraine, Département de Pneumologie, CHRU NANCY
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 Copd and Hypertension, Pulmonary, run by Central Hospital, Nancy, France 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 1 inclusion and 8 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 25 Sep 2024. 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?
Response to treatment (time frame: 3 - 12 months). 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 NCT06613321, which also lists 1 linked publication.
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 25 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.