Chronic Obstructive Pulmonary Disease (COPD)AIRFLOWNCT02058459
Targeted Lung Denervation for Patients With Moderate to Severe COPD
A study testing Holaira™ Lung Denervation System with energy delivery and Holaira™ Lung Denervation System without energy delivery in people with Chronic Obstructive Pulmonary Disease (COPD), run by Nuvaira, Inc. at 18 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Holaira™ Lung Denervation System with energy delivery and Holaira™ Lung Denervation System without energy delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 4 Aug 2014to 16 Jun 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD with 30% ≤ FEV1 < 60% and FEV1/FVC <70% (post-bronchodilator);
- Patient ≥ 40 and ≤ 75 years of age at the time of consent;
- The patient has no child bearing potential or a negative pregnancy test (serum or urine), if applicable;
- Smoking history of at least 10 pack years;
- Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study;
- Participated in a pulmonary rehabilitation program or engaged in regular physical activity under professional supervision in the past 12 months;
Who cannot join
- Has been less than 6 weeks following the resolution of a COPD exacerbation or active lower respiratory infection (eg. pneumonia);
- History of recurrent respiratory infections and/or COPD exacerbations (more than 2 hospitalizations within 1 year of enrollment);
- Prior lung or chest procedure (eg. lung transplant, LVRS, BLVR, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, segmentectomy, or lobectomy);
- Documented history of asthma diagnosed with onset <30 years of age, cystic fibrosis, paradoxical vocal cord motion, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, severe interstitial lung disease or active tuberculosis;
- Pulmonary nodule requiring follow-up or intervention unless proven benign;
- Daily use of >10 mg of prednisone or its equivalent at the time of enrollment;
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Germany6 sites
Charite-Universitatsmedizin Berlin
Berlin, 13353
Universitatklinikum Bonn
Bonn
Ruhrlandklinik - West German Lung Center
Essen, 45239
Asklepios-Fachkliniken
Gauting, 82131
Thoraxklinik Heidelberg
Heidelberg, D-69126
Klinikverbund Kempten-Oberallgaeu
Kempten, 87509
France5 sites
CHU de Grenoble
Grenoble, 38700
CHU de Lille
Lille, 59000
CHU de Paris - Hopital Bichat Claude Bernard
Paris
CHU de Reims
Reims, 51092
CHU de Strasbourg
Strasbourg, 67000
Austria2 sites
AKH Allgemeines Krankenhaus der Stadt Linz GmbH
Linz
Otto-Wagner-Spital
Vienna, 1140
Belgium2 sites
CHU Saint Pierre
Brussels, 1000
University Hospital Leuven
Leuven, 3000
Netherlands2 sites
Academic Medical Center
Amsterdam
Universtity Medical Center Groningen
Groningen, The Netherlands, 9700
About this study
Official title: A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.
The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.
Read the detailed description
A prospective, sequential two phase multicenter, randomized double-blind, safety, \& feasibility study. The goal of AIRFLOW-1 will be to compare two energy doses and select the optimal energy dose to be utilized in AIRFLOW-2. The goal of AIRFLOW-2 is to compare the optimal energy dose to a sham control. All subjects will be followed for a minimum of 3 years.
- Being tested
- Holaira™ Lung Denervation System with energy delivery, Holaira™ Lung Denervation System without energy delivery
- Keywords
- COPD, Targeted Lung Denervation, Intervention, Lung Function, Safety, Device
- 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.
Holaira™ Lung Denervation System with energy deliveryDevice
Holaira™ Lung Denervation System without energy deliveryDevice
| Study group | Role | What they receive |
|---|---|---|
| Targeted Lung Denervation | Active comparator | active targeted lung denervation Receives: Device: Holaira™ Lung Denervation System with energy delivery |
| Sham-Control | Sham comparator | non-active targeted lung denervation Receives: Device: Holaira™ Lung Denervation System without energy delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months
Respiratory adverse events is defined as: worsening bronchitis, worsening dyspnea, common cold, COPD exacerbation, influenza, pneumonia, respiratory infection, respiratory failure, tachypnea and wheezing. Subjects may have reported more than one type of respiratory adverse event.
Measured: 3-6.5 months
Secondary outcomes (8)
Adverse events over 3 years
The assessment of safety will be based on reporting of adverse events, particularly those adverse events that are respiratory in origin.
Measured: 3 years
Device Success
Device success is defined as ability to deliver the test device to its intended locations, provide complete circumferential treatment and removal of the test device without the report of an adverse event during the procedure.
Measured: 6 months
Spirometry measures
Measures include: FEV1, FVC, FEV1/FVC
Measured: 3 years
Change in Functional testing: Cycle Ergometry & 6MWT
Measured: 3 years
Heath-related Quality of Life (SGRQ-C & EQ-5D)
Measured: 3 years
Procedure Success
Procedure Success is defined as device success without the report of an adverse event through hospital discharge.
Measured: Through discharge
Plethysmography measures
Measures include Raw, TLC, IC, ITGW
Measured: 3 years
CT Scan assessment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study start4 Aug 2014
- Primary completion26 Jan 2018
- Study completion16 Jun 2020
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 Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvaira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dirk-Jan Slebos, MD, Principal investigator, University Medical Center GroningenArschang Valipour, MD, Principal investigator, Otto-Wagner-Spital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058459
- Sponsor's protocol ID
- AIRFLOW
- Acronym
- AIRFLOW
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2014
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Valipour A, Shah PL, Herth FJ, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Conway F, Duller M, Mayse M, Norman HS, Slebos DJ; AIRFLOW-2 Trial Study Group. Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2. Int J Chron Obstruct Pulmon Dis. 2020 Nov 5;15:2807-2816. doi: 10.2147/COPD.S267409. eCollection 2020.
PubMed 33177818Slebos DJ, Shah PL, Herth FJF, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Srikanthan K, Duller M, Valipour A; AIRFLOW-2 Study Group. Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe Chronic Obstructive Pulmonary Disease (AIRFLOW). A Multicenter Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 15;200(12):1477-1486. doi: 10.1164/rccm.201903-0624OC.
PubMed 31404499
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.
- ClinicalTrials.gov ID
- NCT02058459
- Acronym / sponsor ID
- AIRFLOW / AIRFLOW
- Keywords
- COPD, Targeted Lung Denervation, Intervention, Lung Function, Safety, Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Nuvaira, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2014 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 10 Feb 2014 (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 evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.
Detailed description
A prospective, sequential two phase multicenter, randomized double-blind, safety, \& feasibility study. The goal of AIRFLOW-1 will be to compare two energy doses and select the optimal energy dose to be utilized in AIRFLOW-2. The goal of AIRFLOW-2 is to compare the optimal energy dose to a sham control. All subjects will be followed for a minimum of 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Lung Denervation | Active comparator | Device: Holaira™ Lung Denervation System with energy deliveryactive targeted lung denervation |
| Sham-Control | Sham comparator | Device: Holaira™ Lung Denervation System without energy deliverynon-active targeted lung denervation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of COPD with 30% ≤ FEV1 < 60% and FEV1/FVC <70% (post-bronchodilator);
- Patient ≥ 40 and ≤ 75 years of age at the time of consent;
- The patient has no child bearing potential or a negative pregnancy test (serum or urine), if applicable;
- Smoking history of at least 10 pack years;
- Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study;
Key exclusion criteria (6 listed)
- Has been less than 6 weeks following the resolution of a COPD exacerbation or active lower respiratory infection (eg. pneumonia);
- History of recurrent respiratory infections and/or COPD exacerbations (more than 2 hospitalizations within 1 year of enrollment);
- Prior lung or chest procedure (eg. lung transplant, LVRS, BLVR, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, segmentectomy, or lobectomy);
- Documented history of asthma diagnosed with onset <30 years of age, cystic fibrosis, paradoxical vocal cord motion, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, severe interstitial lung disease or active tuberculosis;
- Pulmonary nodule requiring follow-up or intervention unless proven benign;
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 |
|---|---|---|
| Holaira™ Lung Denervation System with energy delivery | Device | Targeted Lung Denervation |
| Holaira™ Lung Denervation System without energy delivery | Device | Sham-Control |
Primary outcome
AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months
Time frame: 3-6.5 months
Respiratory adverse events is defined as: worsening bronchitis, worsening dyspnea, common cold, COPD exacerbation, influenza, pneumonia, respiratory infection, respiratory failure, tachypnea and wheezing. Subjects may have reported more than one type of respiratory adverse event.
8 secondary outcomes
Adverse events over 3 years
Time frame: 3 years
Device Success
Time frame: 6 months
Spirometry measures
Time frame: 3 years
Change in Functional testing: Cycle Ergometry & 6MWT
Time frame: 3 years
Heath-related Quality of Life (SGRQ-C & EQ-5D)
Time frame: 3 years
Procedure Success
Time frame: Through discharge
Plethysmography measures
Time frame: 3 years
CT Scan assessment
Time frame: 3 years
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 13 Apr 2022.
- Derived from this study: PubMed 33177818Valipour A, Shah PL, Herth FJ, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Conway F, Duller M, Mayse M, Norman HS, Slebos DJ; AIRFLOW-2 Trial Study Group. Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2. Int J Chron Obstruct Pulmon Dis. 2020 Nov 5;15:2807-2816. doi: 10.2147/COPD.S267409. eCollection 2020.
- Derived from this study: PubMed 31404499Slebos DJ, Shah PL, Herth FJF, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Srikanthan K, Duller M, Valipour A; AIRFLOW-2 Study Group. Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe Chronic Obstructive Pulmonary Disease (AIRFLOW). A Multicenter Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 15;200(12):1477-1486. doi: 10.1164/rccm.201903-0624OC.
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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.
Dirk-Jan Slebos, MD principal investigator
University Medical Center Groningen
Arschang Valipour, MD principal investigator
Otto-Wagner-Spital
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holaira™ Lung Denervation System with energy delivery and Holaira™ Lung Denervation System without energy delivery in people with Chronic Obstructive Pulmonary Disease (COPD), run by Nuvaira, Inc. at 18 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 6 inclusion and 6 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 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, France, Austria, Belgium, Netherlands 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. Some participants in this study may receive a placebo. 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?
AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months (time frame: 3-6.5 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 NCT02058459, 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 13 Apr 2022.