Pulmonary Disease, Chronic ObstructiveNCT02719184
Longitudinal Follow up to Assess Biomarkers Predictive of Emphysema Progression in Patients With COPD (Chronic Obstructive Pulmonary Disease)
An observational study of Pulmonary Disease, Chronic Obstructive and Pulmonary Emphysema, run by Boehringer Ingelheim at 51 sites in 12 countries.
Trial summary
The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125 COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125 COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ genotype). Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema
- How many people
- 463 participants
- Where
- 51 sitesin 12 countries
- Study dates
- 13 Apr 2016to 14 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers and COPD patients
Who may be able to join
- General Inclusion Criteria
- Male or female healthy subjects or COPD (GOLD I to III) outpatients with or without A1AT deficiency
- Ex-smokers for at least 9 months with a smoking history of >=20 pack years
- Signed informed consent consistent with ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) guidelines prior to participation in the study, which includes the application of study restrictions
- Age >= 40 and <=70 years
- Body mass index (BMI) of >= 18 and <= 35 kg/m2 (<= 30 kg/m2 in the MRI subset)
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- Ability to perform all study related procedures including technically acceptable pulmonary function tests, body plethysmography, DLCO ( Diffusing Capacity of the lungs for Carbon Monoxide) , sputum induction (if applicable), chest CT (Computed Tomography) and MRI (if applicable)
- Inclusion Criteria Specific for Patients with COPD - Patients must have a current diagnosis of COPD made by a physician prior to or during Visit 1 and a mMRC (Modified Medical Research Council Dyspnea Scale) score of 1 or more. The diagnosis of COPD must be in accordance with GOLD Guidelines and must be documented by the following criteria: Known relatively stable airway obstruction with a post-bronchodilator FEV1 (Forced Expiratory Volume in first second)/FVC (Forced Vital Capacity) < 70 %
- The current COPD must be mild, moderate or severe based on lung functions and symptoms and the clinical situation must have stabilized for at least 4 weeks prior to Visit 1. The following definitions adapted from the GOLD Guidelines apply:
- mild: post-broncho-dilator FEV1 >=80% of predicted normal (GLI 2012 and JRS 2014) at Visit 1
- moderate: 50%<= post-broncho-dilator FEV1 < 80% of predicted normal (GLI 2012 and JRS 2014) without chronic respiratory failure at Visit 1
- severe: 30%<= post-bronchodilator FEV1 <50% of predicted normal (GLI 2012 and JRS 2014) without chronic respiratory failure at Visit 1
- Patients must be on stable therapy (not limited to respiratory medication) for the last 4 weeks prior to Visit 1
- Inclusion Criteria Specific Patients with COPD and A1AT Deficiency
- Documented A1AT deficiency of ZZ genotype
- Normal lung function values at Visit 1 with a documented post-bronchodilator FEV1 >=80% of predicted normal (GLI 2012 and JRS 2014) and a post-bronchodilator FEV1/FVC >= lower limit of normal
- Mean post DLCO over all acceptable measurements at Visit 1 of >= 70% of predicted normal
- Further inclusion criteria apply
Who cannot join
- General Exclusion Criteria
- Previous participation in this study or participation in another trial with an investigational drug within 6 weeks prior to Visit 1 or during the study
- Significant pulmonary disease or other significant medical conditions* (as determined by medical history, examination and clinical investigations at screening) that may in the opinion of the investigator result in any of the following:
- Put the subject at risk because of participation in the study
- Cause concern regarding the subject's ability to participate in this study *e.g. rheumatoid arthritis, inflammatory bowel disease, severe liver disease, psoriasis, hematological, infectious and psychiatric diseases
- Documented history of asthma. For allergic rhinitis or atopy, source documentation to verify that the subject does not have asthma
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- Planned surgery during the study expected to interfere with study procedures and outcome
- Blood withdrawal of more than 100 mL within the past 6 weeks prior to Visit 1 and between Visit 1 and 2
- Significant alcohol or drug abuse within past 2 years prior to Visit 1
- Women who are pregnant, nursing or plan to become pregnant while in the study
- Place of permanent residence of less than 3 months prior to Visit 1
- For the MRI subset: subject who do not meet the following criteria for the MRI assessment at Visit 2: systolic blood pressure between 90 and 180 mmHg (SBP), diastolic blood pressure between 50 and 110 mmHg (DBP), pulse rate between 40 and 110 bpm, ear temperature between 35 - 37.5 C, and a glomerular filtration rate (GFR) >= 30 mL/min (GFR must not be older than 14 days from the MRI assessment)
- Respiratory tract infection or COPD exacerbation in the 4 weeks prior to Visit 1 or during the screening period prior to Visit 2, if rescheduling rules cannot be met
- Exclusion Criteria Specific Patients with COPD and A1AT Deficiency
- Newly added anti-inflammatory treatment within 4 weeks prior to Visit 1
- Patients on treatment with PDE (Phosphodiesterase)-5 inhibitors (e.g. Roflumilast) and maintenance treatment Methylxanthines (e.g. Theophylline)
- Hospitalisation for respiratory failure during the year prior to Visit 1
- A history of cystic fibrosis
- Clinical diagnosis of bronchiectasis requiring specific treatment
- Clinically relevant abnormal baseline hematology and blood chemistry
- Known active tuberculosis
- Patients with change in any therapy within 4 weeks prior to Visit 1
- Current and planned A1AT augmentation therapy
- A malignancy for which the patient has undergone resection, radiation or chemotherapy within past 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed
- Inability to comply with restrictions regarding diet, life style and medication
- Further exclusion criteria apply
Trial locations and contacts
51 sites in 12 countries.
51 sites in 12 countries
United States11 sites
Johns Hopkins University
Baltimore, Maryland, 21224
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
National Jewish Health
Denver, Colorado, 80206
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108
Diagnostics Research Group
San Antonio, Texas, 78229
University of California San Diego
San Diego, California, 92103-8415
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Canada6 sites
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 1Z1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
McMaster University Medical Centre
Hamilton, Ontario, L8N 4K1
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
IUCPQ (Laval University)
Québec, G1V 4G5
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Spain6 sites
Hospital del Mar
Barcelona, 08003
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital Son Espases
Palma de Mallorca, 07010
Hospital Quirónsalud Madrid
Pozuelo de Alarcón, 28223
Japan5 sites
Kagoshima University Hospital
Kagoshima, Kagoshima, 890-8520
Showa University Fujigaoka Hospital
Kanagawa, Yokohama, 227-8501
Kishiwada City Hospital
Osaka, Kishiwada, 596-8501
Osaka City University Hospital
Osaka, Osaka, 545-8586
Showa University Hospital
Tokyo, Shinagawa-ku, 142-8666
Germany4 sites
IKF Pneumologie GmbH & Co. KG
Frankfurt, 60596
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Fraunhofer ITEM
Hanover, 30625
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, 23552
South Korea4 sites
Konkuk University Medical Center
Seoul, 05030
SMG-SNU Boramae Medical Center
Seoul, 07061
Korea University Guro Hospital
Seoul, 08308
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 22711
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham, B15 2GW
Glenfield Hospital
Leicester, LE3 9QP
Royal Free Hospital
London, NW3 2PF
Medicines Evaluation Unit
Manchester, M23 9QZ
Denmark3 sites
Aarhus University Hospital
Aarhus N, 8200
Gentofte Hospital
Hellerup, 2900
Hvidovre Hospital
Hvidovre, 2650
Poland3 sites
Respiratory Medicine Centre, private prac., Bialystok
Bialystok, 15044
University Clinical Center, Gdansk
Gdansk, 80 952
Institute of Tuberculosis & Lung Disease, Warsaw
Warsaw, 01138
Finland2 sites
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 00029
TYKS
Turku, 20520
About this study
Official title: Observational Study in Healthy Subjects and Patients With COPD to Assess the Relationship Between Clinical, Imaging and Biomarker Measurements, and Progression of Emphysema Over Three Years [FOOTPRINTS®].
The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125 COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125 COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ genotype). Soluble and imaging biomarkers will be investigated addressing different aspects of disease pathways postulated to be relevant for COPD progression.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | All eligible healthy subjects were included in this group. The observational period is 156 weeks. | |
| COPD GOLD I | All eligible patients with Chronic Obstructive Pulmonary Disease (COPD) grade 1 according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) were included in this group. The observational period is 156 weeks. | |
| COPD GOLD II | All eligible patients with Chronic Obstructive Pulmonary Disease (COPD) grade 2 according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) were included in this group. The observational period is 156 weeks. | |
| COPD GOLD III | All eligible patients with Chronic Obstructive Pulmonary Disease (COPD) grade 3 according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) were included in this group. The observational period is 156 weeks. | |
| COPD and A1AT Deficiency | All eligible patients with Chronic Obstructive Pulmonary Disease (COPD) and Alpha one anti-trypsin (A1AT) deficiency were included in this group. The observational period is 156 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change From Baseline at Week 156 in Adjusted Lung Density (ALD) Based on Percentile Density at 15% (PD15) Adjusted for Lung Volume
The absolute change from baseline at Week 156 in adjusted lung density (ALD) based on Percentile Density at 15% (PD15) adjusted for lung volume was reported. The ALD was calculated as: Percentile Density at 15% (PD15) [gram/Liter (L)] * (Inspiratory volume [L]/predicted total lung volume [L]). The absolute change from baseline in ALD gram/Liter (g/L) was analyzed by Mixed Model for Repeated Measures (MMRM).
Measured: Up to Week 156. Change from baseline value at Week 156 was reported.
Annual Rate of Lung Function Decline Based on Forced Expiratory Volume in 1 Second (FEV1)
The annual rate of lung function decline based on Forced Expiratory Volume in 1 second (FEV1) was reported. The annual rate was estimated from a random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time [Year], and including diagnosis group-by-time interaction. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.
Measured: Up to Week 156
Number of Participants by the Category of Number of Exacerbations During Study
Number of participants by the category of number of exacerbations (no exacerbation, 1 exacerbation, or >= 2 exacerbations) during study was reported.
Measured: Up to Week 156
Duration of Exacerbations During Study (Per Year)
The duration of exacerbations for each subject was calculated as: sum of duration of episodes during study (days)*(365.25/ number of days in study).
Measured: Up to 156 weeks
Number of Participants With at Least Moderate Exacerbation During Study by the Category of Number of Moderate Exacerbations
Number of participants with at least moderate exacerbation during study by the category of number of moderate exacerbation (no moderate exacerbation, 1 moderate exacerbation, or >= 2 moderate exacerbations) was reported.
Measured: Up to 156 weeks
Number of Participants With Severe Exacerbations During Study by the Category of Number of Severe Exacerbations
Number of participants with severe exacerbations during study by the category of number of severe exacerbations (no severe exacerbation, 1 severe exacerbation, or >= 2 severe exacerbations) was reported.
Measured: Up to 156 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start13 Apr 2016
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719184
- Sponsor's protocol ID
- 352.2069
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2016
- Last updated
- 16 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Publications
Crapo JD, Gupta A, Lynch DA, Turner AM, Mroz RM, Janssens W, Ludwig-Sengpiel A, Koegler H, Eleftheraki A, Risse F, Diefenbach C. Baseline characteristics from a 3-year longitudinal study to phenotype subjects with COPD: the FOOTPRINTS study. Respir Res. 2023 Nov 17;24(1):290. doi: 10.1186/s12931-023-02584-2.
PubMed 37978492Crapo J, Gupta A, Lynch DA, Vogel-Claussen J, Watz H, Turner AM, Mroz RM, Janssens W, Ludwig-Sengpiel A, Beck M, Langellier B, Ittrich C, Risse F, Diefenbach C. FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD. BMJ Open. 2021 Mar 22;11(3):e042526. doi: 10.1136/bmjopen-2020-042526.
PubMed 33753437
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study in Healthy Subjects and Patients With COPD to Assess the Relationship Between Clinical, Imaging and Biomarker Measurements, and Progression of Emphysema Over Three Years [FOOTPRINTS®].
- ClinicalTrials.gov ID
- NCT02719184
- Acronym / sponsor ID
- 352.2069
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Posted 16 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125 COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125 COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ genotype). Soluble and imaging biomarkers will be investigated addressing different aspects of disease pathways postulated to be relevant for COPD progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | –All eligible healthy subjects were included in this group. The observational period is 156 weeks. |
| COPD GOLD I | – | –All eligible patients with Chronic Obstructive Pulmonary Disease (COPD) grade 1 according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) were included in this group. The observational period is 156 weeks. |
| COPD GOLD II | – | –All eligible patients with Chronic Obstructive Pulmonary Disease (COPD) grade 2 according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) were included in this group. The observational period is 156 weeks. |
| COPD GOLD III | – | –All eligible patients with Chronic Obstructive Pulmonary Disease (COPD) grade 3 according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) were included in this group. The observational period is 156 weeks. |
| COPD and A1AT Deficiency | – | –All eligible patients with Chronic Obstructive Pulmonary Disease (COPD) and Alpha one anti-trypsin (A1AT) deficiency were included in this group. The observational period is 156 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers and COPD patients
Key inclusion criteria (18 listed)
- General Inclusion Criteria
- Male or female healthy subjects or COPD (GOLD I to III) outpatients with or without A1AT deficiency
- Ex-smokers for at least 9 months with a smoking history of >=20 pack years
- Signed informed consent consistent with ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) guidelines prior to participation in the study, which includes the application of study restrictions
- Age >= 40 and <=70 years
Key exclusion criteria (26 listed)
- General Exclusion Criteria
- Previous participation in this study or participation in another trial with an investigational drug within 6 weeks prior to Visit 1 or during the study
- Significant pulmonary disease or other significant medical conditions* (as determined by medical history, examination and clinical investigations at screening) that may in the opinion of the investigator result in any of the following:
- Documented history of asthma. For allergic rhinitis or atopy, source documentation to verify that the subject does not have asthma
- Planned surgery during the study expected to interfere with study procedures and outcome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absolute Change From Baseline at Week 156 in Adjusted Lung Density (ALD) Based on Percentile Density at 15% (PD15) Adjusted for Lung Volume
Time frame: Up to Week 156. Change from baseline value at Week 156 was reported.
The absolute change from baseline at Week 156 in adjusted lung density (ALD) based on Percentile Density at 15% (PD15) adjusted for lung volume was reported. The ALD was calculated as: Percentile Density at 15% (PD15) [gram/Liter (L)] * (Inspiratory volume [L]/predicted total lung volume [L]). The absolute change from baseline in ALD gram/Liter (g/L) was analyzed by Mixed Model for Repeated Measures (MMRM).
Annual Rate of Lung Function Decline Based on Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Up to Week 156
The annual rate of lung function decline based on Forced Expiratory Volume in 1 second (FEV1) was reported. The annual rate was estimated from a random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time [Year], and including diagnosis group-by-time interaction. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.
Number of Participants by the Category of Number of Exacerbations During Study
Time frame: Up to Week 156
Number of participants by the category of number of exacerbations (no exacerbation, 1 exacerbation, or >= 2 exacerbations) during study was reported.
Duration of Exacerbations During Study (Per Year)
Time frame: Up to 156 weeks
The duration of exacerbations for each subject was calculated as: sum of duration of episodes during study (days)*(365.25/ number of days in study).
Number of Participants With at Least Moderate Exacerbation During Study by the Category of Number of Moderate Exacerbations
Time frame: Up to 156 weeks
Number of participants with at least moderate exacerbation during study by the category of number of moderate exacerbation (no moderate exacerbation, 1 moderate exacerbation, or >= 2 moderate exacerbations) was reported.
Number of Participants With Severe Exacerbations During Study by the Category of Number of Severe Exacerbations
Time frame: Up to 156 weeks
Number of participants with severe exacerbations during study by the category of number of severe exacerbations (no severe exacerbation, 1 severe exacerbation, or >= 2 severe exacerbations) was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37978492Crapo JD, Gupta A, Lynch DA, Turner AM, Mroz RM, Janssens W, Ludwig-Sengpiel A, Koegler H, Eleftheraki A, Risse F, Diefenbach C. Baseline characteristics from a 3-year longitudinal study to phenotype subjects with COPD: the FOOTPRINTS study. Respir Res. 2023 Nov 17;24(1):290. doi: 10.1186/s12931-023-02584-2.
- Derived from this study: PubMed 33753437Crapo J, Gupta A, Lynch DA, Vogel-Claussen J, Watz H, Turner AM, Mroz RM, Janssens W, Ludwig-Sengpiel A, Beck M, Langellier B, Ittrich C, Risse F, Diefenbach C. FOOTPRINTS study protocol: rationale and methodology of a 3-year longitudinal observational study to phenotype patients with COPD. BMJ Open. 2021 Mar 22;11(3):e042526. doi: 10.1136/bmjopen-2020-042526.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
51 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Pulmonary Emphysema, run by Boehringer Ingelheim at 51 sites in 12 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 18 inclusion and 26 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Canada, Spain, Japan, Germany and 7 more countries. 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?
Yes. Results are posted in the registry (first posted 16 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Change From Baseline at Week 156 in Adjusted Lung Density (ALD) Based on Percentile Density at 15% (PD15) Adjusted for Lung Volume (time frame: Up to Week 156. Change from baseline value at Week 156 was reported.). The study lists 6 primary outcomes in all. 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 NCT02719184, 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 16 Aug 2024.