MedDataX Logo

DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy

NCT ID: NCT02552160

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3732 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-24

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life under real conditions and to find out what types of patients are selected for this therapy by physicians.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01908140

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

NCT01462942

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

NCT01572792

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

Observational Study of Adherence to LABA / LAMA in Chronic Obstructive Pulmonary Disease (COPD)

NCT01937390

Pulmonary Disease, Chronic Obstructive
COMPLETED

Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

NCT01078623

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Retrospective aspect of documentation: For patients who have already been changed over to a fixed-dose combination, lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover will be documented.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients on Duaklir® Genuair®

Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol)

No interventions assigned to this group

Patients on Ultibro® Breezhaler®

Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol)

No interventions assigned to this group

Patients on Anoro®

Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female/male of at least 40 years of age
* Patient diagnosed with COPD
* Patient was changed over within the last 3 months to a fixed-dose combination (FDC) (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol), or there is already the intent to change the patient over to a fixed-dose combination (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol).
* Lung function parameters and CAT score from the time prior to the changeover to an FDC are on record (within the last 6 months in the case of patients who have already been changed over) or are determined at the 1st visit (in the case of patients who have not yet been changed over but for whom such a changeover is intended).
* Signed declaration of consent

Exclusion Criteria

* The prescribing information for the fixed-dose combinations (Duaklir® Genuair®, Ulibtro® Breezhaler® or Anoro®) list contraindications for the patient.
* Patient is pregnant, plans to become pregnant, or is nursing during the therapy period.
* Patient suffers from hypersensitivity to one of the active ingredients of the fixed-dose combinations.
* Patient is participating in a clinical trial.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Aachen, D6570r00001, Germany

Site Status

Research Site

Aldenhofen, D6570r00001, Germany

Site Status

Research Site

Aldenhoven, D6570r00001, Germany

Site Status

Research Site

Alzey, D6570r00001, Germany

Site Status

Research Site

Ansbach, D6570r00001, Germany

Site Status

Research Site

Apolda, D6570r00001, Germany

Site Status

Research Site

Aschau, D6570r00001, Germany

Site Status

Research Site

Auerbach, D6570r00001, Germany

Site Status

Research Site

Augsburg, D6570r00001, Germany

Site Status

Research Site

Bad Fallingbostel, D6570r00001, Germany

Site Status

Research Site

Bad Hersfeld, D6570r00001, Germany

Site Status

Research Site

Bad Honnef, D6570r00001, Germany

Site Status

Research Site

Bad Lippspringe, D6570r00001, Germany

Site Status

Research Site

Bad Reichenhall, D6570r00001, Germany

Site Status

Research Site

Bad Sachsa, D6570r00001, Germany

Site Status

Research Site

Bad Windsheim, D6570r00001, Germany

Site Status

Research Site

Bad Wörishofen, D6570r00001, Germany

Site Status

Research Site

Bamberg, D6570r00001, Germany

Site Status

Research Site

Beelitz-Heilstätten, D6570r00001, Germany

Site Status

Research Site

Bergisch Gladbach, D6570r00001, Germany

Site Status

Research Site

Berlin, D6570r00001, Germany

Site Status

Research Site

Biberach, D6570r00001, Germany

Site Status

Research Site

Birkenwerder, D6570r00001, Germany

Site Status

Research Site

Bitterfeld-Wolfen, D6570r00001, Germany

Site Status

Research Site

Bochum, D6570r00001, Germany

Site Status

Research Site

Bonn, D6570r00001, Germany

Site Status

Research Site

Bottrop, D6570r00001, Germany

Site Status

Research Site

Böhlen, D6570r00001, Germany

Site Status

Research Site

Braunschweig, D6570r00001, Germany

Site Status

Research Site

Bruchsal, D6570r00001, Germany

Site Status

Research Site

Burghaslach, D6570r00001, Germany

Site Status

Research Site

Burgwedel, D6570r00001, Germany

Site Status

Research Site

Büchen, D6570r00001, Germany

Site Status

Research Site

Celle, D6570r00001, Germany

Site Status

Research Site

Chemnitz, D6570r00001, Germany

Site Status

Research Site

Cologne, D6570r00001, Germany

Site Status

Research Site

Cottbus, D6570r00001, Germany

Site Status

Research Site

Darmstadt, D6570r00001, Germany

Site Status

Research Site

Delitzsch, D6570r00001, Germany

Site Status

Research Site

Dessau, D6570r00001, Germany

Site Status

Research Site

Dorsten, D6570r00001, Germany

Site Status

Research Site

Dortmund, D6570r00001, Germany

Site Status

Research Site

Dresden, D6570r00001, Germany

Site Status

Research Site

Duisburg, D6570r00001, Germany

Site Status

Research Site

Düren, D6570r00001, Germany

Site Status

Research Site

Düsseldorf, D6570r00001, Germany

Site Status

Research Site

Eimsheim, D6570r00001, Germany

Site Status

Research Site

Ellerstadt, D6570r00001, Germany

Site Status

Research Site

Elsterwerda, D6570r00001, Germany

Site Status

Research Site

Elterlein, D6570r00001, Germany

Site Status

Research Site

Essen, D6570r00001, Germany

Site Status

Research Site

Euerbach-Obbach, D6570r00001, Germany

Site Status

Research Site

Euskirchen, D6570r00001, Germany

Site Status

Research Site

Flensburg, D6570r00001, Germany

Site Status

Research Site

Frankfurt, D6570r00001, Germany

Site Status

Research Site

Frankfurt/M., D6570r00001, Germany

Site Status

Research Site

Freiberg, D6570r00001, Germany

Site Status

Research Site

Fürstenwalde, D6570r00001, Germany

Site Status

Research Site

Fürth, D6570r00001, Germany

Site Status

Research Site

Ganderkesee, D6570r00001, Germany

Site Status

Research Site

Garching, D6570r00001, Germany

Site Status

Research Site

Garmisch-Partenkirchen, D6570r00001, Germany

Site Status

Research Site

Gauting, D6570r00001, Germany

Site Status

Research Site

Gera, D6570r00001, Germany

Site Status

Research Site

Gerwisch, D6570r00001, Germany

Site Status

Research Site

Glienicke, D6570r00001, Germany

Site Status

Research Site

Greiz, D6570r00001, Germany

Site Status

Research Site

Gütersloh, D6570r00001, Germany

Site Status

Research Site

Hagen, D6570r00001, Germany

Site Status

Research Site

Halberstadt, D6570r00001, Germany

Site Status

Research Site

Halle, D6570r00001, Germany

Site Status

Research Site

Hamburg, D6570r00001, Germany

Site Status

Research Site

Hanover, D6570r00001, Germany

Site Status

Research Site

Hartenstein, D6570r00001, Germany

Site Status

Research Site

Heidelberg, D6570r00001, Germany

Site Status

Research Site

Hemmingen, D6570r00001, Germany

Site Status

Research Site

Hettstedt, D6570r00001, Germany

Site Status

Research Site

Hoyerswerda, D6570r00001, Germany

Site Status

Research Site

Höchstadt an der Aisch, D6570r00001, Germany

Site Status

Research Site

Ibbenbueren, D6570r00001, Germany

Site Status

Research Site

Ingolstadt, D6570r00001, Germany

Site Status

Research Site

Iserlohn, D6570r00001, Germany

Site Status

Research Site

Issum, D6570r00001, Germany

Site Status

Research Site

Jena, D6570r00001, Germany

Site Status

Research Site

Karlsruhe, D6570r00001, Germany

Site Status

Research Site

Kevelaer, D6570r00001, Germany

Site Status

Research Site

Kleve, D6570r00001, Germany

Site Status

Research Site

Koeln-Hoehenberg, D6570r00001, Germany

Site Status

Research Site

Koeln-Rodenkirchen, D6570r00001, Germany

Site Status

Research Site

Kolbermoor, D6570r00001, Germany

Site Status

Research Site

Köthen, D6570r00001, Germany

Site Status

Research Site

Krefeld, D6570r00001, Germany

Site Status

Research Site

Kronach, D6570r00001, Germany

Site Status

Research Site

Kyritz, D6570r00001, Germany

Site Status

Research Site

Langenfeld, D6570r00001, Germany

Site Status

Research Site

Leer, D6570r00001, Germany

Site Status

Research Site

Leipzig, D6570r00001, Germany

Site Status

Research Site

Leonberg, D6570r00001, Germany

Site Status

Research Site

Lippstadt, D6570r00001, Germany

Site Status

Research Site

Ludwigsburg-Ossweil, D6570r00001, Germany

Site Status

Research Site

Ludwigshafen, D6570r00001, Germany

Site Status

Research Site

Lübeck, D6570r00001, Germany

Site Status

Research Site

Magdeburg, D6570r00001, Germany

Site Status

Research Site

Mainz, D6570r00001, Germany

Site Status

Research Site

Mannheim, D6570r00001, Germany

Site Status

Research Site

Marburg, D6570r00001, Germany

Site Status

Research Site

Markt Bibart, D6570r00001, Germany

Site Status

Research Site

Menden, D6570r00001, Germany

Site Status

Research Site

Merzig, D6570r00001, Germany

Site Status

Research Site

Moers, D6570r00001, Germany

Site Status

Research Site

Monheim, D6570r00001, Germany

Site Status

Research Site

Mosbach, D6570r00001, Germany

Site Status

Research Site

Mönchengladbach, D6570r00001, Germany

Site Status

Research Site

Mühlhausen, D6570r00001, Germany

Site Status

Research Site

München, D6570r00001, Germany

Site Status

Research Site

Neumarkt, D6570r00001, Germany

Site Status

Research Site

Neunkirchen, D6570r00001, Germany

Site Status

Research Site

Neuruppin, D6570r00001, Germany

Site Status

Research Site

Neusäß, D6570r00001, Germany

Site Status

Research Site

Neustadt/Aisch, D6570r00001, Germany

Site Status

Research Site

Neuwied, D6570r00001, Germany

Site Status

Research Site

Nuremberg, D6570r00001, Germany

Site Status

Research Site

Oettingen in Bayern, D6570r00001, Germany

Site Status

Research Site

Oschatz, D6570r00001, Germany

Site Status

Research Site

Oy-Mittelberg, D6570r00001, Germany

Site Status

Research Site

Pirmasens, D6570r00001, Germany

Site Status

Research Site

Potsdam, D6570r00001, Germany

Site Status

Research Site

Pulheim-Braunweiler, D6570r00001, Germany

Site Status

Research Site

Radebeul, D6570r00001, Germany

Site Status

Research Site

Rastatt, D6570r00001, Germany

Site Status

Research Site

Rathenow, D6570r00001, Germany

Site Status

Research Site

Recklinghausen, D6570r00001, Germany

Site Status

Research Site

Remscheid, D6570r00001, Germany

Site Status

Research Site

Reutlingen, D6570r00001, Germany

Site Status

Research Site

Rosenheim, D6570r00001, Germany

Site Status

Research Site

Rostock, D6570r00001, Germany

Site Status

Research Site

Roth, D6570r00001, Germany

Site Status

Research Site

Rust, D6570r00001, Germany

Site Status

Research Site

Rüdersdorf, D6570r00001, Germany

Site Status

Research Site

Rüsselsheim am Main, D6570r00001, Germany

Site Status

Research Site

Saalfeld, D6570r00001, Germany

Site Status

Research Site

Saarbrücken, D6570r00001, Germany

Site Status

Research Site

Saarlouis, D6570r00001, Germany

Site Status

Research Site

Schleswig, D6570r00001, Germany

Site Status

Research Site

Schmölln, D6570r00001, Germany

Site Status

Research Site

Schönbrunn, D6570r00001, Germany

Site Status

Research Site

Schwedt, D6570r00001, Germany

Site Status

Research Site

Siegen, D6570r00001, Germany

Site Status

Research Site

Simmern, D6570r00001, Germany

Site Status

Research Site

Solingen, D6570r00001, Germany

Site Status

Research Site

Sonsbeck, D6570r00001, Germany

Site Status

Research Site

Spiesen, D6570r00001, Germany

Site Status

Research Site

Spremberg, D6570r00001, Germany

Site Status

Research Site

Steinhagen, D6570r00001, Germany

Site Status

Research Site

Strausberg, D6570r00001, Germany

Site Status

Research Site

Straßkirchen, D6570r00001, Germany

Site Status

Research Site

Stuttgart, D6570r00001, Germany

Site Status

Research Site

Sulzberg, D6570r00001, Germany

Site Status

Research Site

Teterow, D6570r00001, Germany

Site Status

Research Site

Teuchern, D6570r00001, Germany

Site Status

Research Site

Thaleischweiler-Fröschen, D6570r00001, Germany

Site Status

Research Site

Trier, D6570r00001, Germany

Site Status

Research Site

Ulm, D6570r00001, Germany

Site Status

Research Site

Unterwellenborn, D6570r00001, Germany

Site Status

Research Site

Ursensollen, D6570r00001, Germany

Site Status

Research Site

Voerde, D6570r00001, Germany

Site Status

Research Site

Wallenhorst, D6570r00001, Germany

Site Status

Research Site

Wardenburg, D6570r00001, Germany

Site Status

Research Site

Waren, D6570r00001, Germany

Site Status

Research Site

Warendorf, D6570r00001, Germany

Site Status

Research Site

Wehrheim, D6570r00001, Germany

Site Status

Research Site

Weilheim, D6570r00001, Germany

Site Status

Research Site

Weißenburg, D6570r00001, Germany

Site Status

Research Site

Weißwasser, D6570r00001, Germany

Site Status

Research Site

Wiesbaden, D6570r00001, Germany

Site Status

Research Site

Witten, D6570r00001, Germany

Site Status

Research Site

Wittenberg, D6570r00001, Germany

Site Status

Research Site

Worms, D6570r00001, Germany

Site Status

Research Site

Wuppertal, D6570r00001, Germany

Site Status

Research Site

Zwönitz, D6570r00001, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Related Links

Access external resources that provide additional context or updates about the study.

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3934&filename=DETECT_Report_Synopsis_20180720_final_Redacted_f_CTgov.pdf

CSR Synopsis

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D6570R00001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD Patients
NCT02579850 COMPLETED PHASE3
Evaluation of Long-Acting Muscarinic Antagonists in COPD
NCT02039050 COMPLETED PHASE4
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00706914 TERMINATED PHASE2
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
NCT01794780 COMPLETED PHASE4
Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01204034 COMPLETED PHASE3
Aclidinium/Formoterol Fixed Combination Dose Finding Study
NCT00626522 COMPLETED PHASE2
Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
NCT01049360 COMPLETED PHASE2
Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
NCT03162055 COMPLETED PHASE3
Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01437397 COMPLETED PHASE3
Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
NCT04655170 UNKNOWN PHASE4
Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)
NCT02467452 COMPLETED PHASE3
Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
NCT02164539 COMPLETED PHASE2
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01437540 COMPLETED PHASE3
Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
NCT02238171 COMPLETED
Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients
NCT03022097 COMPLETED PHASE3
Study in Patients' With Persistent Asthma and Chronic Obstructive Pulmonary Disease
NCT02419872 COMPLETED
A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation
NCT01712516 COMPLETED PHASE3
A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))
NCT01342913 COMPLETED PHASE3
Comparative Study of Fluticasone Furoate(FF)/Umeclidinium Bromide (UMEC)/ Vilanterol (VI) Closed Therapy Versus FF/VI Plus UMEC Open Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT02729051 COMPLETED PHASE3
The Effect of Twice Daily vs. Once Daily Bronchodilation on Hyperinflation in COPD Patients During 24 Hours.
NCT03275116 UNKNOWN PHASE4
An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients
NCT02799784 COMPLETED PHASE4
Comparative Effectiveness of COPD Treatments
NCT03376295 COMPLETED
Effectiveness of Triple Therapy in COPD
NCT03724877 COMPLETED
A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01879410 COMPLETED PHASE3
Post-marketing Surveillance of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
NCT02233894 COMPLETED