EmphysemaNCT05118269
A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial
A study testing Treatment plus Optimal Medical Therapy and Optimal Medical Therapy in people with Emphysema, run by Uptake Medical Technology, Inc. at 1 site in France.
Trial summary
This study is designed to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with InterVapor® in patients with heterogeneous emphysema with upper lobe predominance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Emphysema
- What is being tested?
- Treatment plus Optimal Medical Therapy and Optimal Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2023to 4 Jun 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and ≤ 80 years old
- Heterogeneous emphysema with upper lobe predominance in at least one lung segment to be treated (defined as a Heterogeneity Index (HI) ≥ 1.2 per CT)
- Post-bronchodilator FEV1 ≥ 15% and ≤ 45% of predicted value
- Total lung capacity (TLC) ≥ 100% predicted
- Post-bronchodilator Residual volume (RV) ≥ 200% predicted
- 6-minute walk distance (6MWD) > 100m and ≤ 450m
Show all 17Show fewer
- (Partial Pressure of Oxygen) PaCO2 ≤ 45 mm Hg; PaO2 > 45 mm Hg on room air
- Non-smoking for 4 months prior to study enrollment as confirmed by:
- negative urine analysis or serum cotinine level of ≤ 10 ng/mL, or negative CO Hb test OR
- If using smoking cessation product(s) containing nicotine at screening, serum cotinine level ≤ 13.7 ng/ml (or arterial carboxyhemoglobin ≤ 2.5%)
- Optimized medical management (consistent with GOLD guidelines)
- Pharmacological:
- 1.Long acting bronchodilator (LABA),Long-acting muscarinic antagonists (LAMA), LAMA + LABA, or LABA + ICS > 1 year
- Evidence of completed Pulmonary Rehabilitation
- ≥ 6 weeks out-patient or ≥ 3 weeks in-patient within 12 months of enrollment; or,
- Patient has or continues to participate in at home rehabilitation program (i.e. a walking program) within 6 weeks of enrollment under the supervision of a health care professional
- 10. Mentally and physically able to provide written informed consent to participate in the study. Protected people as defined by the Code de la Sante Publique cannot be included in the study
Who cannot join
- DLCO < 20% predicted
- Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram
- Clinically significant bronchiectasis
- Clinically significant (greater than 4 tablespoons per day) sputum production.
- Two (2) or more COPD exacerbations or pneumonia episodes requiring hospitalization in the last year
- Evidence of active infection in the lungs at the time of procedure.
Show all 24Show fewer
- Daily use of systemic steroids, > 10 mg prednisolone (or equivalent) daily.
- Lung pathology of nodule not proven stable or benign
- Clinically significant pulmonary fibrosis
- Prior lung transplant, lung volume reduction surgery (LVRS), bullectomy, or lobectomy
- Prior lung volume reduction via endobronchial valves(s), coil(s), and/or polymer. Note: Patients whose endobronchial valves have been removed can be treated if: all valves removed ≥ 3 months prior to InterVapor and baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation
- Large bulla (defined as > 1/3 volume of the lobe)
- Highly diseased upper and lower lobes in contralateral lung (%-950 HU density >50%)
- Paraseptal emphysema in any segment targeted for treatment
- Myocardial Infarction or congestive heart failure within 6 months of screening.
- Diagnosis of heart failure with Left Ventricular Ejection Fraction (LVEF) < 45% as determined by recent echocardiogram (completed within 3 months prior to screening).
- Unable to safely discontinue anti-coagulants or platelet inhibitors for 6 weeks post procedure.
- Body mass index (BMI) > 32 kg/m2
- Patient taking immunosuppressive drugs for the treatment of cancer, rheumatic arthritis, autoimmune disease, or prevention of tissue or organ rejection.
- Subject is pregnant or lactating, or plan to become pregnant within the study timeframe
- Any disease or condition that is likely to limit survival to less than one year
- Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with InterVapor®
- Currently enrolled in another clinical trial studying an experimental treatment.
- Any condition that would interfere with completion of the study including study assessments and study procedure including bronchoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeted Segmental Vapor Ablation Treatment of Emphysema With Upper Lobe Predominance: A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial
This study is designed to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with InterVapor® in patients with heterogeneous emphysema with upper lobe predominance. For validity of the study, the results will be compared to patients that receive optimal medical therapy.
Read the detailed description
The primary objectives are to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with Bronchoscopic Thermal Vapor Ablation (BTVA) using the InterVapor system in patients with heterogeneous emphysema with upper lobe predominance. The French TARGET trial is a prospective, multi-center, single blind, randomized controlled study. 150 participants will be enrolled in the study (1:1 randomization with 75 InterVapor, 75 controls) with a 24-month follow-up period. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment once they have completed the protocol defined 12-month follow-up period.
- Conditions
- Emphysema
- Being tested
- Treatment plus Optimal Medical Therapy, Optimal Medical Therapy
- Keywords
- Heterogeneous, Thermal Vapor, Ablation, Bronchoscopy, LVR, Lung Volume Reduction
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment plus Optimal Medical TherapyDevice
Also called InterVapor, BTVA
Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/World Health Organization , Global Initiative for Chronic Obstructive Lung Disease (GOLD) workshop summary).
Optimal Medical TherapyOther
Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
| Study group | Role | What they receive |
|---|---|---|
| Treatment plus Optimal Medical Therapy | Experimental | Patients will be treated with the InterVapor System and Optimal Medical Therapy Receives: Device: Treatment plus Optimal Medical Therapy |
| Optimal Medical Therapy (Control) | Active comparator | Patients will be treated according to Optimal Medical Therapy Receives: Other: Optimal Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FEV1 between Treatment vs Control at 12 months
Percentage change in Forced expiratory volume in 1 second (FEV1) compared to active comparator: Change in FEV1, percent change from baseline to 12 months in FEV1, where FEV1 is expressed in raw units of volume (mL).
Measured: 12 months
St. George's Respiratory Questionnaire for patients with Chronic Obstructive Pulmonary Disease (SGRQ-C) changes between Treatment vs Control at 12 months
Health-related Qualify of Life (SGRQ-C) compared to active comparator. This is calculated as change from baseline to 12 months in SGRQ-C Total Score. SGRQ-C scores range from 0 to 100. A higher score means a worse outcome.
Measured: 12 months
Secondary outcomes (19)
Improvement in other measures of pulmonary function- Forced Expiratory Volume, absolute change- at 12, 18 and 24 months
Change in FEV1, abs: Absolute change from baseline to follow-up in FEV1, where FEV1 is expressed in raw units of volume (mL).
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Forced Expiratory Volume, Percent change- at 12, 18 and 24 months
Change in FEV1, Percent Predicted value: Percent change from baseline to follow-up in FEV1, where FEV1 is expressed in percent predicted computed by European Respiratory Standard (ERS) standards.
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Forced Expiratory Volume, Abs, PP change- at 12, 18 and 24 months
Change in FEV1, abs, PP: absolute change from baseline to follow-up in FEV1, where FEV1 is expressed in percent predicted computed by ERS standards.
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Forced Vital Capacity(FVC) change- at 12, 18 and 24 months
Change in FVC: percent change from baseline to follow-up in Forced Vital Capacity, expressed in raw units of volume(mL)
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Forced Vital Capacity Percent Predicted change- at 12, 18 and 24 months
Change in FVC PP: percent change from baseline to follow-up in Forced Vital Capacity, expressed in percent predicted computed by ERS standards
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Residual Volume- at 12, 18 and 24 months
Percent change from baseline to follow-up in Residual Volume
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Residual Volume-Abs at 12, 18 and 24 months
Percent change from baseline to follow-up in Residual Volume, where RV is expressed in raw units of volume (mL).
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Residual Volume-Percent Predicted value at 12, 18 and 24 months
Percent change from baseline to follow-up in Residual Volume, where RV is expressed in percent predicted computed by ERS standards.
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Residual Volume-Abs Percent Predicted value at 12, 18 and 24 months
Absolute change from baseline to follow-up in Residual Volume, where RV is expressed in percent predicted computed by ERS standards
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Percent Predicted Value at 12, 18 and 24 months
Percent change from baseline to follow-up in Diffusing Capacity of the Lungs for Carbon Monoxide, where DLCO is expressed in percent predicted computed by ERS standards.
Measured: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Absolute Percent Predicted Value at 12, 18 and 24 months
Absolute change from baseline to follow-up in Diffusing Capacity of the Lungs for Carbon Monoxide, where DLCO is expressed in percent predicted computed by ERS standards.
Measured: 12 months, 18 months, 24 months
Changes in segmental lung volumes from as assessed by CT at 12, 18 and 24 months
Changes in segmental lung volumes from baseline to 12 months as assessed by CT
Measured: 12 months, 18 months, 24 months
Changes in pulmonary function tests as assessed by body plethysmography measures at 12, 18 and 24 months
Changes in pulmonary function tests as assessed by body plethysmography measures at 12 months
Measured: 12 months, 18 months, 24 months
Number of serious adverse events and fatal events
Number of serious adverse events (SAEs) and fatal events
Measured: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for FEV1 at 12, 18 and 24 months
Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following:
- FEV1 (> 12% predicted) in Treatment vs Control at 12 months
Measured: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for SGRQ-C at 12, 18 and 24 months
Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following:
- SGRQ (> 8 points) in Treatment vs Control at 12 months
Measured: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for 6 Minute Walk Distance (6MWD) at 12, 18 and 24 months
Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following:
- 6MWD (> 26m) in Treatment vs Control at 12 months
Measured: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for COPD Assessment Test (CAT) score at 12, 18 and 24 months
Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following:
- CAT Score (> 2 points) in Treatment vs Control at 12 months
Measured: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for Shortness of Breath Questionnaire (SOBQ) score at 12, 18 and 24 months
Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following:
- SOBQ Score (> 5 points) in Treatment vs Control at 12 month
Measured: 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start21 Jul 2023
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Why it stopped: The sponsor made the decision not to conduct this study. No subjects were treated in the study and all centers closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized in a 1:1 ratio between treatment group and control group. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment at 12 months, once they have completed the protocol defined follow-up period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uptake Medical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Guibert, Prof, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118269
- Sponsor's protocol ID
- CSP-2250
- Status last verified
- Feb 2025
- First submitted
- 8 Jul 2020
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Segmental Vapor Ablation Treatment of Emphysema With Upper Lobe Predominance: A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial
- ClinicalTrials.gov ID
- NCT05118269
- Acronym / sponsor ID
- CSP-2250
- Conditions
- Emphysema
- Keywords
- Heterogeneous, Thermal Vapor, Ablation, Bronchoscopy, LVR, Lung Volume Reduction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor made the decision not to conduct this study. No subjects were treated in the study and all centers closed.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Uptake Medical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 11 Nov 2021 (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.
This study is designed to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with InterVapor® in patients with heterogeneous emphysema with upper lobe predominance. For validity of the study, the results will be compared to patients that receive optimal medical therapy.
Detailed description
The primary objectives are to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with Bronchoscopic Thermal Vapor Ablation (BTVA) using the InterVapor system in patients with heterogeneous emphysema with upper lobe predominance. The French TARGET trial is a prospective, multi-center, single blind, randomized controlled study. 150 participants will be enrolled in the study (1:1 randomization with 75 InterVapor, 75 controls) with a 24-month follow-up period. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment once they have completed the protocol defined 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a 1:1 ratio between treatment group and control group. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment at 12 months, once they have completed the protocol defined follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Treatment plus Optimal Medical Therapy | Experimental | Device: Treatment plus Optimal Medical TherapyPatients will be treated with the InterVapor System and Optimal Medical Therapy |
| Optimal Medical Therapy (Control) | Active comparator | Other: Optimal Medical TherapyPatients will be treated according to Optimal Medical Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age > 18 and ≤ 80 years old
- Heterogeneous emphysema with upper lobe predominance in at least one lung segment to be treated (defined as a Heterogeneity Index (HI) ≥ 1.2 per CT)
- Post-bronchodilator FEV1 ≥ 15% and ≤ 45% of predicted value
- Total lung capacity (TLC) ≥ 100% predicted
- Post-bronchodilator Residual volume (RV) ≥ 200% predicted
Key exclusion criteria (24 listed)
- DLCO < 20% predicted
- Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram
- Clinically significant bronchiectasis
- Clinically significant (greater than 4 tablespoons per day) sputum production.
- Two (2) or more COPD exacerbations or pneumonia episodes requiring hospitalization in the last year
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 |
|---|---|---|
| Treatment plus Optimal Medical TherapyAlso: InterVapor, BTVAPatients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/World Health Organization , Global Initiative for Chronic Obstructive Lung Disease (GOLD) workshop summary). | Device | Treatment plus Optimal Medical Therapy |
| Optimal Medical TherapyPatients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary). | Other | Optimal Medical Therapy (Control) |
Primary outcome
Changes in FEV1 between Treatment vs Control at 12 months
Time frame: 12 months
Percentage change in Forced expiratory volume in 1 second (FEV1) compared to active comparator: Change in FEV1, percent change from baseline to 12 months in FEV1, where FEV1 is expressed in raw units of volume (mL).
St. George's Respiratory Questionnaire for patients with Chronic Obstructive Pulmonary Disease (SGRQ-C) changes between Treatment vs Control at 12 months
Time frame: 12 months
Health-related Qualify of Life (SGRQ-C) compared to active comparator. This is calculated as change from baseline to 12 months in SGRQ-C Total Score. SGRQ-C scores range from 0 to 100. A higher score means a worse outcome.
19 secondary outcomes
Improvement in other measures of pulmonary function- Forced Expiratory Volume, absolute change- at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Forced Expiratory Volume, Percent change- at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Forced Expiratory Volume, Abs, PP change- at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Forced Vital Capacity(FVC) change- at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Forced Vital Capacity Percent Predicted change- at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Residual Volume- at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Residual Volume-Abs at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Residual Volume-Percent Predicted value at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function- Residual Volume-Abs Percent Predicted value at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Percent Predicted Value at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Absolute Percent Predicted Value at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Changes in segmental lung volumes from as assessed by CT at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Changes in pulmonary function tests as assessed by body plethysmography measures at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Number of serious adverse events and fatal events
Time frame: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for FEV1 at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for SGRQ-C at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for 6 Minute Walk Distance (6MWD) at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for COPD Assessment Test (CAT) score at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Binary responder analysis to determine minimally clinical important difference for Shortness of Breath Questionnaire (SOBQ) score at 12, 18 and 24 months
Time frame: 12 months, 18 months, 24 months
Results and safety
The study was stopped early (reason given: The sponsor made the decision not to conduct this study. No subjects were treated in the study and all centers closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- 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.
Nicolas Guibert, Prof principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment plus Optimal Medical Therapy and Optimal Medical Therapy in people with Emphysema, run by Uptake Medical Technology, Inc. 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 17 inclusion and 24 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: stopped early, as of the sponsor's last update on 27 Feb 2025. 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 was stopped early (reason given: The sponsor made the decision not to conduct this study. No subjects were treated in the study and all centers closed.). Results are not available in the source record.
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 in FEV1 between Treatment vs Control at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 27 Feb 2025.