COPDTRANSFORMNCT02022683
To Improve Lung Function and Symptoms for Emphysema Patients Using Zephyr Valves
A study testing ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves in people with COPD and Heterogeneous Emphysema, run by Pulmonx Corporation at 17 sites in 6 countries.
Trial summary
To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Heterogeneous Emphysema
- What is being tested?
- ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 28 Jan 2014to 27 Sep 2018
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtained informed consent.
- Diagnosis of heterogeneous emphysema with a heterogeneity index of ≥10 % between target and adjacent lobes.
- Subjects of both genders of at least 40 years of age.
- 15 % predicted ≤ FEV1≤ 45% predicted.
- TLC > 100% and RV ≥ 180% predicted.
- 150 meters < 6MWD < 450 meters.
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- Non-smoker >8 weeks prior to signing the Informed Consent.
- CV negative target lobe.
- Additional inclusion criterion French CIP:
- If treated in France, Subject must be entitled to French social security
Who cannot join
- Any contraindication for bronchoscopic procedure.
- Evidence of active pulmonary infection.
- History of 2 or more exacerbations requiring hospitalization over the past 12 months.
- Known pulmonary hypertension that according to the physician will be unsuitable for EBV treatment.
- Myocardial infarction or other relevant cardiovascular events in the past 6 months.
- Significant bronchiectasis seen at CT scan.
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- Greater than two tablespoons of sputum production per day.
- Prior LVR or LVRS procedure. Criterion 8 French CIP wording*: Prior lung transplant, median sternotomy, LVR or LVRS procedure (including lobectomy).
- Pulmonary nodule requiring follow-up within any lobe.
- Pregnant or nursing women. French CIP wording*: Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
- Hypercapnia (paCO2 > 7.33 kPa).
- Current diagnosis of asthma.
- > 25mg Prednisolon (or equivalent) use/days.
- Any other condition that as judged by the investigator may make follow-up or investigations inappropriate.
- Evidence of pleural adhesions or earlier pulmonary surgery.
- Severe Bullous Emphysema (> 1/3 Hemithorax)
- Any subject that according to the Declaration of Helsinki is unsuitable for enrollment.
- Additional exclusion criteria in the French CIP:
- History of allergy to silicone and/or nitinol.
- If treated in France, Subject is a "personne vulnerable" as defined by French regulation.
- Simultaneous participation in another drug and/or medical device related clinical.
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
United Kingdom5 sites
University Hospital of Wales
Cardiff, CF144XW
West of Scotland Regional Heart & Lung Centre - Golden Jubilee National Hospital
Clydebank, West Dunbartonshire Scotland, G81 4DY
The Royal Brompton Hospital & Harefield NHS Foundation Trust
London, SW3 6NP
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S5 7AU
Sherwood Forest Hospitals NHS
Sutton in Ashfield, Nottinghamshire, NG17 4JL
France4 sites
CHU
Grenoble, 38043
CHU Hôpital Pasteur
Nice, 06002
Groupe Hospitalier Pitié Salpétrière
Paris, 75013
Hôpital Bichat Claude Bernard
Paris, 75877
Germany3 sites
Charité Campus Virchow-Klinikum
Berlin, 13353
Ruhrlandklinik Westdeutsches Lungenzentrum
Essen, 45239
Thoraxklinik am Universitäts Klinikum Heidelberg
Heidelberg, 69126
Sweden2 sites
Skane University Hospital
Lund, 221 85
Uppsala University Hospital
Uppsala, 751 85
About this study
Official title: A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.
- Conditions
- COPD, Heterogeneous Emphysema
- Being tested
- ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves
- Keywords
- Endoscopic lung volume reduction, Endobronchial valves
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELVR (Endoscopic Lung Volume Reduction) with Zephyr ValvesDevice
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Lung Volume Reduction | Experimental | Patients are implanted with Zephyr Valves Receives: Device: ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves |
| Standard of Care | No intervention | Patients are given Standard Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1-second (FEV1) - Responders
The percentage of trial participants in the EBV treatment arm meeting the minimally clinically important difference (MCID) of >12% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 3 months post-procedure.
Measured: Between baseline and 3 months
Secondary outcomes (13)
St George's Respiratory Questionnaire (SGRQ) - Absolute change
Absolute change in the SGRQ in the EBV treatment arm at 3, 6, 12, 18 and 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.
The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:
Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)
A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Between Baseline and 3, 6, 12, 18 and 24 months
St George's Respiratory Questionnaire (SGRQ) - Percent change
Percent change in the SGRQ in the EBV treatment arm at 3, 6, 12, 18 and 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.
The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:
Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)
A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Between Baseline and 3, 6, 12, 18 and 24 months
St George's Respiratory Questionnaire (SGRQ) - Responders
Percentage of subject achieving the MCID for SGRQ in the EBV treatment arm at 3, 6, 12, 18 and 24 months, compared to SoC at 3, 6 and 12 months.
The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:
Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)
A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Between Baseline and 3, 6, 12, 18 and 24 months
6-minute walk distance (6MWT) - Absolute change
Absolute change in 6MWD in the EBV treatment arm at 3, 6, 12, 18, 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.
Measured: Between Baseline and 3, 6, 12, 18, 24 months
6-minute walk distance (6MWT) - Percent change
Percent change in 6MWD in the EBV treatment arm at 3, 6, 12, 18, 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.
Measured: Between Baseline and 3, 6, 12, 18, 24 months
6-minute walk distance (6MWT) - Responders
Percentage of subject achieving the MCID for 6MWD in the EBV treatment arm at 3, 6, 12, 18 and 24 months, compared to SoC at 3, 6 and 12 months.
Measured: Between Baseline and 3, 6, 12, 18, 24 months
Forced Expiratory Volume in 1-second (FEV1) - Absolute change
Absolute change in FEV1 in the EBV treatment arm at 3, 6, 12, 18, 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.
Measured: Between Baseline and 3, 6, 12, 18, 24 months
Forced Expiratory Volume in 1-second (FEV1) - Percent change
Percentage of subject achieving the MCID for FEV1 in the EBV treatment arm at 6, 12, 18 and 24 months, compared to SoC at 6 and 12 months.
Measured: Between Baseline and 6, 12, 18 and 24 months
Forced Expiratory Volume in 1-second (FEV1) - Responders
Absolute change in FEV1 in the EBV treatment arm at 3, 6, 12, 18, 24 months relative to Baseline and the difference between the two arms at 3, 6 and 12 months.
Measured: Between Baseline and 3, 6, 12, 18, 24 months
mMRC (Modified Medical Research Council) score - Responders
Percentage of subject in the EBV treatment arm achieving the MCID for the Modified Scale Research Council Dyspnea Score (mMRC) at 3, 6, 12, 18 and 24 months and the difference between the two arms at 3, 6 and 12 months.
The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.
Measured: Between Baseline and 3, 6, 12, 18 and 24 months
Target Lobar Volume Reduction (TLVR) - Absolute change
Absolute change in target lobe volume at 45 days in the EBV treatment arm relative to Baseline as assessed by quantitative HRCT analysis (TLVR: Target Lobar Volume Reduction).
Measured: Between baseline and 45 days
Target Lobar Volume Reduction (TLVR) - Percent change
Percent change in target lobe volume at 45 days in the EBV treatment arm relative to Baseline as assessed by quantitative HRCT analysis (TLVR: Target Lobar Volume Reduction).
Measured: Between baseline and 45 days
Target Lobar Volume Reduction (TLVR) - Responders
Percentage of subjects in EBV arm with a TLVR > 350ml at 45 days relative to baseline.
Measured: Between baseline and 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study start28 Jan 2014
- Primary completion20 Jan 2017
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmonx Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gunnar Hillerdal, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022683
- Sponsor's protocol ID
- 630-0015/A
- Acronym
- TRANSFORM
- Status last verified
- Jun 2019
- First submitted
- 17 Dec 2013
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.
PubMed 39515624Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hubner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.
PubMed 28885054
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
- ClinicalTrials.gov ID
- NCT02022683
- Acronym / sponsor ID
- TRANSFORM / 630-0015/A
- Conditions
- COPD, Heterogeneous Emphysema
- Keywords
- Endoscopic lung volume reduction, Endobronchial valves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Pulmonx CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2014 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 30 Dec 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.
To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Lung Volume Reduction | Experimental | Device: ELVR (Endoscopic Lung Volume Reduction) with Zephyr ValvesPatients are implanted with Zephyr Valves |
| Standard of Care | No intervention | –Patients are given Standard Medical Care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Obtained informed consent.
- Diagnosis of heterogeneous emphysema with a heterogeneity index of ≥10 % between target and adjacent lobes.
- Subjects of both genders of at least 40 years of age.
- 15 % predicted ≤ FEV1≤ 45% predicted.
- TLC > 100% and RV ≥ 180% predicted.
Key exclusion criteria (21 listed)
- Any contraindication for bronchoscopic procedure.
- Evidence of active pulmonary infection.
- History of 2 or more exacerbations requiring hospitalization over the past 12 months.
- Known pulmonary hypertension that according to the physician will be unsuitable for EBV treatment.
- Myocardial infarction or other relevant cardiovascular events in the past 6 months.
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 |
|---|---|---|
| ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves | Device | Endoscopic Lung Volume Reduction |
Primary outcome
Forced Expiratory Volume in 1-second (FEV1) - Responders
Time frame: Between baseline and 3 months
The percentage of trial participants in the EBV treatment arm meeting the minimally clinically important difference (MCID) of >12% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 3 months post-procedure.
13 secondary outcomes
St George's Respiratory Questionnaire (SGRQ) - Absolute change
Time frame: Between Baseline and 3, 6, 12, 18 and 24 months
St George's Respiratory Questionnaire (SGRQ) - Percent change
Time frame: Between Baseline and 3, 6, 12, 18 and 24 months
St George's Respiratory Questionnaire (SGRQ) - Responders
Time frame: Between Baseline and 3, 6, 12, 18 and 24 months
6-minute walk distance (6MWT) - Absolute change
Time frame: Between Baseline and 3, 6, 12, 18, 24 months
6-minute walk distance (6MWT) - Percent change
Time frame: Between Baseline and 3, 6, 12, 18, 24 months
6-minute walk distance (6MWT) - Responders
Time frame: Between Baseline and 3, 6, 12, 18, 24 months
Forced Expiratory Volume in 1-second (FEV1) - Absolute change
Time frame: Between Baseline and 3, 6, 12, 18, 24 months
Forced Expiratory Volume in 1-second (FEV1) - Percent change
Time frame: Between Baseline and 6, 12, 18 and 24 months
Forced Expiratory Volume in 1-second (FEV1) - Responders
Time frame: Between Baseline and 3, 6, 12, 18, 24 months
mMRC (Modified Medical Research Council) score - Responders
Time frame: Between Baseline and 3, 6, 12, 18 and 24 months
Target Lobar Volume Reduction (TLVR) - Absolute change
Time frame: Between baseline and 45 days
Target Lobar Volume Reduction (TLVR) - Percent change
Time frame: Between baseline and 45 days
Target Lobar Volume Reduction (TLVR) - Responders
Time frame: Between baseline and 45 days
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 2 Jul 2019.
- Derived from this study: PubMed 39515624Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.
- Derived from this study: PubMed 28885054Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hubner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.
- 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.
Gunnar Hillerdal, MD, PhD principal investigator
Uppsala University Hospital
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves in people with COPD and Heterogeneous Emphysema, run by Pulmonx Corporation at 17 sites in 6 countries.
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 10 inclusion and 21 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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, France, Germany, Belgium, Sweden and 1 more country. 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?
Forced Expiratory Volume in 1-second (FEV1) - Responders (time frame: Between baseline and 3 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 NCT02022683, which also lists 2 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 2 Jul 2019.