COPDAIRFLOW-3NCT03639051
Evaluation of the Safety and Efficacy of TLD in Patients with COPD
A study testing Targeted Lung Denervation (TLD) and Optimal Medical Care in people with COPD, run by Nuvaira, Inc. at 33 sites in 6 countries.
Trial summary
The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Targeted Lung Denervation (TLD) and Optimal Medical Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 464 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 23 May 2019to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject ≥40 years of age at the time of consent;
- Women of child bearing potential must not be pregnant, evidenced by a negative pregnancy test (blood or urine) pre-treatment, or lactating and agree not to become pregnant for the duration of the study;
- Smoking history of at least 10 pack years;
- Not smoking or using any other inhaled substance (e.g., cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not start for the duration of the study;
- Subject has received a flu vaccination within the 12 months prior to the procedure or agrees to obtain vaccination once it becomes available and agrees to annual vaccinations for the duration of the study;
- Resting SpO2 ≥89% on room air at the time of screening;
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- CAT score ≥10 at the time of screening;
- Diagnosis of COPD with 25%≤ FEV1 ≤80% of predicted, PaCO2 ˂ 50 (if FEV1 ˂30%) and FEV1/FVC <70% (post-bronchodilator);
- Documented history of ≥ 2 moderate COPD exacerbations or ≥ 1 severe COPD exacerbation leading to hospitalization in the 12 months prior to consent with at least one exacerbation occurring while the subject was on optimal medical care (taking LAMA and a LABA, or scheduled SABA or SAMA instead of either a LAMA or LABA, not both, as regular respiratory maintenance medication);
- Subject is on optimal medical care at the time of consent;
- If subject has participated in a formal pulmonary rehabilitation program recently, program completion must have occurred ≥3 months prior to consent; if in a maintenance program, subject agrees to continue their current program through their 12-month follow-up visit;
- Subject is a candidate for bronchoscopy in the opinion of the physician or per hospital guidelines and is able to discontinue blood thinning medication peri-procedurally;
- The subject is able and agrees to complete all protocol required baseline and follow-up tests and assessments including taking certain medications (e.g., azithromycin, prednisolone/prednisone);
- Subject has provided written informed consent using a form that has been reviewed and approved by the Institutional Review Board (IRB)/Ethics Committee (EC).
Who cannot join
- Body Mass Index <18 or >35;
- Subject has an implantable electronic device and has not received appropriate medical clearance;
- Uncontrolled diabetes in the opinion of the investigator;
- Malignancy treated with radiation or chemotherapy within 1 year of consent;
- Asthma as defined by the current Global Initiative for Asthma (GINA) guidelines;
- Subject diagnosed with a dominant non-COPD lung disease or condition affecting the lungs, which is the main driver of the subjects clinical symptoms (e.g., cystic fibrosis, paradoxical vocal cord motion, eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillosis, interstitial lung disease or active tuberculosis) or has a documented medical history of pneumothorax within 1 year of consent;
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- Clinically relevant bronchiectasis, defined as severe single lobe or multilobar broncial wall thickening associated with airway dilation on CT scan leading to cough and tenacious sputum on most days;
- Pre-existing diagnosis of pulmonary hypertension, clinical evidence of pulmonary hypertension (e.g., cardiovascular function impairment including peripheral edema) and mPAP ≥25 mmHg at rest by right heart catheterization (or estimated right ventricular systolic pressure >50 mmHg by echocardiogram if no previous right heart catheterization);
- Myocardial infarction within last 6 months, EKG with evidence of life threatening arrhythmias or acute ischemia, pre-existing documented evidence of an LVEF <40%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure, or any other past or present cardiac findings that make the subject an unacceptable candidate for a bronchoscopic procedure utilizing general anesthesia;
- Surgical procedure(s) on the stomach, esophagus or pancreas performed ≤2 years of consent or ongoing related symptoms within the past year;
- Symptomatic gastric motility disorder(s) (e.g., gastroparesis) as evidenced by a GCSI score ≥18.0, severe uncontrolled GERD (e.g., refractory heartburn, endoscopic esophagitis) or severe dysphagia (e.g., esophageal stricture, achalasia, esophageal spasm);
- Any disease or condition that might interfere with completion of a procedure or this study (e.g., structural esophageal disorder, life expectancy <3 years);
- Prior lung or chest procedure (e.g., lung transplant, LVRS, BLVR, lung implant, metal stent, valves, median sternotomy, bullectomy, lobectomy, segmentectomy or other interventional lung or chest procedure) performed ≤1 year of consent; NOTE: Any metal in the chest must be ≥5 cm away from the anticipated treatment location(s). Subjects with explanted lung valve(s) allowed if explant occurred ≥3 months prior to treatment.
- Daily use of >10 mg of prednisone or its equivalent at the time of consent;
- Chronic use of >40 mg MEDD opioid only medication per day;
- Known contraindication or allergy to medications required for bronchoscopy or general anesthesia (e.g., lidocaine, atropine, propofol, sevoflurane) that cannot be medically controlled;
- Baseline chest CT scan reveals bronchi anatomy cannot be fully treated with available catheter sizes, presence of severe emphysema >50%, lobar attenuation area or severe bullous disease (>1/3 hemithorax) (as determined by the CT core lab using a single density mask threshold of -950 HU) or discovery of a mass that requires treatment;
- Subject is currently enrolled in another interventional clinical trial that has not completed follow-up.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States20 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham (UAB) Lung Health Center
Birmingham, Alabama, 35294
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27710
Suburban Lung Associates
Elk Grove Village, Illinois, 60007
St. Davids HealthCare
Georgetown, Texas, 78626
Spectrum Health Medical Group
Grand Rapids, Michigan, 49546
Houston Methodist Hospital
Houston, Texas, 77030
Ascension St. Vincent's
Jacksonville, Florida, 32204
University of Louisville
Louisville, Kentucky, 40202
Temple Lung Center
Philadelphia, Pennsylvania, 19140
HonorHealth
Phoenix, Arizona, 85258
First Health of the Carolinas
Pinehurst, North Carolina, 28374
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15219
UC Davis
Sacramento, California, 95817
Washington University
St Louis, Missouri, 63110
Harbor UCLA
Torrance, California, 90502
France8 sites
Hopital de la Cavale Blanche
Brest
CHU de Grenoble
Grenoble, Cedex 9, 38043
Arnaud de Villeneuve Hospital
Montpellier
Hopital Pasteur
Nice
Bichat-Claude Bernard Hospital
Paris
CHU de Reims
Reims
CHU de Strasbourg
Strasbourg
Hopital Larrey
Toulouse, Cedex 9, 31400
Netherlands2 sites
UMC
Amsterdam
University Medical Center Groningen (UMCG)
Groningen
About this study
Official title: A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Patients with Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD.
Read the detailed description
The primary objective of this study is to demonstrate the superiority of treatment with the Nuvaira Lung Denervation System (Active Treatment arm) compared to a sham procedure (Sham Control arm) to decrease moderate or severe exacerbations in subjects with COPD on optimal medical care.
The secondary objective is to compare long-term safety, and other efficacy assessments between the Active Treatment arm and the Sham Control arm.
- Conditions
- COPD
- Being tested
- Targeted Lung Denervation (TLD), Optimal Medical Care
- 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.
Targeted Lung Denervation (TLD)Device
Also called TLD, TLD Therapy
Targeted Lung Denervation (TLD) Therapy is a bronchoscopically guided, minimally invasive procedure using the Nuvaira™ Lung Denervation System.
Optimal Medical CareOther
Taking regular maintenance medication that minimally includes a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA).
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Target Lung Denervation (TLD) with the Nuvaira Lung Denervation System (RF energy delivered) and optimal medical care for COPD. Receives: Device: Targeted Lung Denervation (TLD); Other: Optimal Medical Care |
| Sham Control | Sham comparator | Sham Targeted Lung Denervation (TLD) procedure with the Nuvaira Lung Denervation System (catheter placement and balloon deployment in all treatment locations, no RF energy delivered) and optimal medical care for COPD. Receives: Other: Optimal Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate or severe COPD exacerbations
A COPD exacerbation will be defined as a complex of respiratory events/symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea or chest tightness with at least one symptom lasting three days requiring treatment with antibiotics and/or systemic steroids (moderate exacerbation) and/or hospital admission (severe exacerbation).
Measured: Randomization to 12 Months
Secondary outcomes (10)
Time to first severe COPD exacerbation
Defined as a comparison between study arms of the survival distributions for events based on log-rank tests
Measured: Randomization to 12 Months
Time to first severe COPD exacerbation (Subgroup)
Defined as a comparison between study arms of the survival distributions for events based on log-rank tests, only for the subgroup of subjects who had a severe COPD exacerbation in the year prior to randomization.
Measured: Randomization to 12 months
Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score
Defined as a comparison between study arms of the mean change in FVC based on a linear model for change in SGRQ-C, adjusted for baseline SGRQ-C.
The SGRQ-C is a disease-specific HRQL questionnaire with a total and three component scores for: symptoms, activity and impacts; each score ranges from 0 (no impairment) to 100 (worst possible). A difference in four units in the SGRQ-C score is considered the minimum clinically important difference (MCID).
Measured: Randomization to 12 months
Change in FVC
Defined as a comparision between study arms of the mean change in FVC based on a linear model for change in FVC, adjusted for baseline FVC.
Measured: Randomization to 12 Months
Change in FEV1
Defined as a comparison between study arms of the mean change in FEV1 based on a linear model for change in FEV1, adjusted for baseline FEV1.
Measured: Randomization to 12 months
Transition Dyspnea Index (TDI)
Defined as a comparison between study arms of the TDI based on a linear model for change in TDI.
Measured: Randomization to 12 months
Change in RV
Defined as a comparison between study arms of the mean change in RV based on a linear model for change in RV, adjusted for baseline RV.
Measured: Randomization to 12 months
Time to first respiratory-related hospitalization
Defined as a comparison between study arms of the survival distributions for events based on log-rank tests.
Measured: Randomization to 12 Months
Change in Short Form Health Survey (SF-36) total score
Defined as a comparison between study arms of the mean change in SF-36 total score based on a linear model for change in SF-36 total score, adjusted for baseline SF-36 total score.
SF-36 is composed of eight multi-item scales (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health), with scores for each of these scales (or dimensions) ranging from 0 to 100. Higher scores indicate higher HRQoL.
Measured: Randomization to 12 Months
CAT responders
Defined as a comparison between study arms of the proportion of subjects with a greater than or equal to 2 point decrease in CAT.
The CAT is a disease-specific HRQL with eight questions; each score ranges from 0 (no impairment) to 5 (worst possible). The CAT has a scoring range of 0-40. Higher scores denote a more severe impact of COPD on a patient's life. A difference in 2 units in the CAT score over 2 to 3 months suggests a clinically significant difference or change in health status.
Measured: Randomization to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start23 May 2019
- Primary completion1 Oct 2024
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- Subjects will be randomized with equal allocation (1:1) into two arms: TLD therapy plus optimal medical care (Active Treatment) and optimal medical care (Sham Control). Randomization of subjects will be stratified based on investigational site, participation in a pulmonary rehabilitation maintenance program and baseline use of an inhaled corticosteroid at the time of enrollment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvaira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Sciurba, MD, Principal investigator, University of Pittsburgh Medical CenterDirk-Jan Slebos, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639051
- Sponsor's protocol ID
- D0543
- Acronym
- AIRFLOW-3
- Status last verified
- Nov 2024
- First submitted
- 8 Aug 2018
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Shah PL, Slebos DJ, Sue R, Bhatt SP, Ghattas C, Strange C, Degano B, Valipour A, Eisenmann S, De Cardenas J, Marquette CH, Soto-Soto J, Sciurba FC, Conway F, Tonkin J, Tana A, Marchetti N, Hartman JE, Heluain V, Guibert N, Criner GJ. Randomized Sham-controlled Trial of Targeted Lung Denervation in Patients with Chronic Obstructive Pulmonary Disease (AIRFLOW-3). Am J Respir Crit Care Med. 2025 Dec;211(12):2318-2329. doi: 10.1164/rccm.202502-0404OC.
PubMed 40920914Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
PubMed 33590989Slebos DJ, Degano B, Valipour A, Shah PL, Deslee G, Sciurba FC; AIRFLOW-3 Trial Study Group. Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira(R) lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3). BMC Pulm Med. 2020 Feb 13;20(1):41. doi: 10.1186/s12890-020-1058-5.
PubMed 32054473
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Patients with Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03639051
- Acronym / sponsor ID
- AIRFLOW-3 / D0543
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 464 participants (actual)
- Lead sponsor
- Nuvaira, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- Sep 2028 (estimated)
- First posted
- 20 Aug 2018 (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 purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD.
Detailed description
The primary objective of this study is to demonstrate the superiority of treatment with the Nuvaira Lung Denervation System (Active Treatment arm) compared to a sham procedure (Sham Control arm) to decrease moderate or severe exacerbations in subjects with COPD on optimal medical care.
The secondary objective is to compare long-term safety, and other efficacy assessments between the Active Treatment arm and the Sham Control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized with equal allocation (1:1) into two arms: TLD therapy plus optimal medical care (Active Treatment) and optimal medical care (Sham Control). Randomization of subjects will be stratified based on investigational site, participation in a pulmonary rehabilitation maintenance program and baseline use of an inhaled corticosteroid at the time of enrollment.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Device: Targeted Lung Denervation (TLD), Other: Optimal Medical CareTarget Lung Denervation (TLD) with the Nuvaira Lung Denervation System (RF energy delivered) and optimal medical care for COPD. |
| Sham Control | Sham comparator | Other: Optimal Medical CareSham Targeted Lung Denervation (TLD) procedure with the Nuvaira Lung Denervation System (catheter placement and balloon deployment in all treatment locations, no RF energy delivered) and optimal medical care for COPD. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject ≥40 years of age at the time of consent;
- Women of child bearing potential must not be pregnant, evidenced by a negative pregnancy test (blood or urine) pre-treatment, or lactating and agree not to become pregnant for the duration of the study;
- Smoking history of at least 10 pack years;
- Not smoking or using any other inhaled substance (e.g., cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not start for the duration of the study;
- Subject has received a flu vaccination within the 12 months prior to the procedure or agrees to obtain vaccination once it becomes available and agrees to annual vaccinations for the duration of the study;
Key exclusion criteria (18 listed)
- Body Mass Index <18 or >35;
- Subject has an implantable electronic device and has not received appropriate medical clearance;
- Uncontrolled diabetes in the opinion of the investigator;
- Malignancy treated with radiation or chemotherapy within 1 year of consent;
- Asthma as defined by the current Global Initiative for Asthma (GINA) guidelines;
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 |
|---|---|---|
| Targeted Lung Denervation (TLD)Also: TLD, TLD TherapyTargeted Lung Denervation (TLD) Therapy is a bronchoscopically guided, minimally invasive procedure using the Nuvaira™ Lung Denervation System. | Device | Active Treatment |
| Optimal Medical CareTaking regular maintenance medication that minimally includes a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA). | Other | Active Treatment, Sham Control |
Primary outcome
Moderate or severe COPD exacerbations
Time frame: Randomization to 12 Months
A COPD exacerbation will be defined as a complex of respiratory events/symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea or chest tightness with at least one symptom lasting three days requiring treatment with antibiotics and/or systemic steroids (moderate exacerbation) and/or hospital admission (severe exacerbation).
10 secondary outcomes
Time to first severe COPD exacerbation
Time frame: Randomization to 12 Months
Time to first severe COPD exacerbation (Subgroup)
Time frame: Randomization to 12 months
Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score
Time frame: Randomization to 12 months
Change in FVC
Time frame: Randomization to 12 Months
Change in FEV1
Time frame: Randomization to 12 months
Transition Dyspnea Index (TDI)
Time frame: Randomization to 12 months
Change in RV
Time frame: Randomization to 12 months
Time to first respiratory-related hospitalization
Time frame: Randomization to 12 Months
Change in Short Form Health Survey (SF-36) total score
Time frame: Randomization to 12 Months
CAT responders
Time frame: Randomization to 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Derived from this study: PubMed 40920914Shah PL, Slebos DJ, Sue R, Bhatt SP, Ghattas C, Strange C, Degano B, Valipour A, Eisenmann S, De Cardenas J, Marquette CH, Soto-Soto J, Sciurba FC, Conway F, Tonkin J, Tana A, Marchetti N, Hartman JE, Heluain V, Guibert N, Criner GJ. Randomized Sham-controlled Trial of Targeted Lung Denervation in Patients with Chronic Obstructive Pulmonary Disease (AIRFLOW-3). Am J Respir Crit Care Med. 2025 Dec;211(12):2318-2329. doi: 10.1164/rccm.202502-0404OC.
- Derived from this study: PubMed 33590989Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
- Derived from this study: PubMed 32054473Slebos DJ, Degano B, Valipour A, Shah PL, Deslee G, Sciurba FC; AIRFLOW-3 Trial Study Group. Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira(R) lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3). BMC Pulm Med. 2020 Feb 13;20(1):41. doi: 10.1186/s12890-020-1058-5.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Frank Sciurba, MD principal investigator
University of Pittsburgh Medical Center
Dirk-Jan Slebos, MD, PhD principal investigator
University Medical Center Groningen
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Lung Denervation (TLD) and Optimal Medical Care in people with COPD, run by Nuvaira, Inc. at 33 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 14 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, France, Netherlands, Austria, Germany 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?
This study is still under way. Results are not available in the source record yet.
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?
Moderate or severe COPD exacerbations (time frame: Randomization to 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 NCT03639051, which also lists 3 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 14 Nov 2024.