Chronic Obstructive Pulmonary DiseaseDETECTNCT02552160

DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy

An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 180 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
How many people: 3,732 participants
Where: 180 sitesGermany
Study dates: 24 Sep 2015to 31 Dec 2017
How long will I take part?: 12 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients who have been diagnosed with COPD (Chronic obstructive pulmonary disease), who have been changed over within the last 3 months to one of the 3 listed fixed-dose combinations (FDC) or for whom such a changeover is intended, and whose lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover are available (within the last 6 months) or are determined at the time of the 1st visit, if this is planned as part of the routine treatment.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

180 sites in 1 country.

City, postcode or hospital

180 sites in 1 country

Germany180 sites

Research Site
Aachen, D6570r00001, D6570R00001
Research Site
Aldenhofen, D6570r00001, D6570R00001
Research Site
Aldenhoven, D6570r00001, D6570R00001
Research Site
Alzey, D6570r00001, D6570R00001
Research Site
Ansbach, D6570r00001, D6570R00001
Research Site
Apolda, D6570r00001, D6570R00001
Research Site
Aschau, D6570r00001, D6570R00001
Research Site
Auerbach, D6570r00001, D6570R00001
Research Site
Augsburg, D6570r00001, D6570R00001
Research Site
Bad Fallingbostel, D6570r00001, D6570R00001
Research Site
Bad Hersfeld, D6570r00001, D6570R00001
Research Site
Bad Honnef, D6570r00001, D6570R00001
Research Site
Bad Lippspringe, D6570r00001, D6570R00001
Research Site
Bad Reichenhall, D6570r00001, D6570R00001
Research Site
Bad Sachsa, D6570r00001, D6570R00001
Research Site
Bad Windsheim, D6570r00001, D6570R00001
Research Site
Bad Wörishofen, D6570r00001, D6570R00001
Research Site
Bamberg, D6570r00001, D6570R00001
Research Site
Beelitz-Heilstätten, D6570r00001, D6570R00001
Research Site
Bergisch Gladbach, D6570r00001, D6570R00001
Research Site
Berlin, D6570r00001, D6570R00001
Research Site
Biberach, D6570r00001, D6570R00001
Research Site
Birkenwerder, D6570r00001, D6570R00001
Research Site
Bitterfeld-Wolfen, D6570r00001, D6570R00001
Research Site
Bochum, D6570r00001, D6570R00001
Research Site
Böhlen, D6570r00001, D6570R00001
Research Site
Bonn, D6570r00001, D6570R00001
Research Site
Bottrop, D6570r00001, D6570R00001
Research Site
Braunschweig, D6570r00001, D6570R00001
Research Site
Bruchsal, D6570r00001, D6570R00001
Research Site
Büchen, D6570r00001, D6570R00001
Research Site
Burghaslach, D6570r00001, D6570R00001
Research Site
Burgwedel, D6570r00001, D6570R00001
Research Site
Celle, D6570r00001, D6570R00001
Research Site
Chemnitz, D6570r00001, D6570R00001
Research Site
Cologne, D6570r00001, D6570R00001
Research Site
Cottbus, D6570r00001, D6570R00001
Research Site
Darmstadt, D6570r00001, D6570R00001
Research Site
Delitzsch, D6570r00001, D6570R00001
Research Site
Dessau, D6570r00001, D6570R00001
Research Site
Dorsten, D6570r00001, D6570R00001
Research Site
Dortmund, D6570r00001, D6570R00001
Research Site
Dresden, D6570r00001, D6570R00001
Research Site
Duisburg, D6570r00001, D6570R00001
Research Site
Düren, D6570r00001, D6570R00001
Research Site
Düsseldorf, D6570r00001, D6570R00001
Research Site
Eimsheim, D6570r00001, D6570R00001
Research Site
Ellerstadt, D6570r00001, D6570R00001
Research Site
Elsterwerda, D6570r00001, D6570R00001
Research Site
Elterlein, D6570r00001, D6570R00001
Research Site
Essen, D6570r00001, D6570R00001
Research Site
Euerbach-Obbach, D6570r00001, D6570R00001
Research Site
Euskirchen, D6570r00001, D6570R00001
Research Site
Flensburg, D6570r00001, D6570R00001
Research Site
Frankfurt, D6570r00001, D6570R00001
Research Site
Frankfurt/M., D6570r00001, D6570R00001
Research Site
Freiberg, D6570r00001, D6570R00001
Research Site
Fürstenwalde, D6570r00001, D6570R00001
Research Site
Fürth, D6570r00001, D6570R00001
Research Site
Ganderkesee, D6570r00001, D6570R00001
Research Site
Garching, D6570r00001, D6570R00001
Research Site
Garmisch-Partenkirchen, D6570r00001, D6570R00001
Research Site
Gauting, D6570r00001, D6570R00001
Research Site
Gera, D6570r00001, D6570R00001
Research Site
Gerwisch, D6570r00001, D6570R00001
Research Site
Glienicke, D6570r00001, D6570R00001
Research Site
Greiz, D6570r00001, D6570R00001
Research Site
Gütersloh, D6570r00001, D6570R00001
Research Site
Hagen, D6570r00001, D6570R00001
Research Site
Halberstadt, D6570r00001, D6570R00001
Research Site
Halle, D6570r00001, D6570R00001
Research Site
Hamburg, D6570r00001, D6570R00001
Research Site
Hanover, D6570r00001, D6570R00001
Research Site
Hartenstein, D6570r00001, D6570R00001
Research Site
Heidelberg, D6570r00001, D6570R00001
Research Site
Hemmingen, D6570r00001, D6570R00001
Research Site
Hettstedt, D6570r00001, D6570R00001
Research Site
Höchstadt an der Aisch, D6570r00001, D6570R00001
Research Site
Hoyerswerda, D6570r00001, D6570R00001
Research Site
Ibbenbueren, D6570r00001, D6570R00001
Research Site
Ingolstadt, D6570r00001, D6570R00001
Research Site
Iserlohn, D6570r00001, D6570R00001
Research Site
Issum, D6570r00001, D6570R00001
Research Site
Jena, D6570r00001, D6570R00001
Research Site
Karlsruhe, D6570r00001, D6570R00001
Research Site
Kevelaer, D6570r00001, D6570R00001
Research Site
Kleve, D6570r00001, D6570R00001
Research Site
Koeln-Hoehenberg, D6570r00001, D6570R00001
Research Site
Koeln-Rodenkirchen, D6570r00001, D6570R00001
Research Site
Kolbermoor, D6570r00001, D6570R00001
Research Site
Köthen, D6570r00001, D6570R00001
Research Site
Krefeld, D6570r00001, D6570R00001
Research Site
Kronach, D6570r00001, D6570R00001
Research Site
Kyritz, D6570r00001, D6570R00001
Research Site
Langenfeld, D6570r00001, D6570R00001
Research Site
Leer, D6570r00001, D6570R00001
Research Site
Leipzig, D6570r00001, D6570R00001
Research Site
Leonberg, D6570r00001, D6570R00001
Research Site
Lippstadt, D6570r00001, D6570R00001
Research Site
Lübeck, D6570r00001, D6570R00001
Research Site
Ludwigsburg-Ossweil, D6570r00001, D6570R00001
Research Site
Ludwigshafen, D6570r00001, D6570R00001
Research Site
Magdeburg, D6570r00001, D6570R00001
Research Site
Mainz, D6570r00001, D6570R00001
Research Site
Mannheim, D6570r00001, D6570R00001
Research Site
Marburg, D6570r00001, D6570R00001
Research Site
Markt Bibart, D6570r00001, D6570R00001
Research Site
Menden, D6570r00001, D6570R00001
Research Site
Merzig, D6570r00001, D6570R00001
Research Site
Moers, D6570r00001, D6570R00001
Research Site
Mönchengladbach, D6570r00001, D6570R00001
Research Site
Monheim, D6570r00001, D6570R00001
Research Site
Mosbach, D6570r00001, D6570R00001
Research Site
Mühlhausen, D6570r00001, D6570R00001
Research Site
München, D6570r00001, D6570R00001
Research Site
Neumarkt, D6570r00001, D6570R00001
Research Site
Neunkirchen, D6570r00001, D6570R00001
Research Site
Neuruppin, D6570r00001, D6570R00001
Research Site
Neusäß, D6570r00001, D6570R00001
Research Site
Neustadt/Aisch, D6570r00001, D6570R00001
Research Site
Neuwied, D6570r00001, D6570R00001
Research Site
Nuremberg, D6570r00001, D6570R00001
Research Site
Oettingen in Bayern, D6570r00001, D6570R00001
Research Site
Oschatz, D6570r00001, D6570R00001
Research Site
Oy-Mittelberg, D6570r00001, D6570R00001
Research Site
Pirmasens, D6570r00001, D6570R00001
Research Site
Potsdam, D6570r00001, D6570R00001
Research Site
Pulheim-Braunweiler, D6570r00001, D6570R00001
Research Site
Radebeul, D6570r00001, D6570R00001
Research Site
Rastatt, D6570r00001, D6570R00001
Research Site
Rathenow, D6570r00001, D6570R00001
Research Site
Recklinghausen, D6570r00001, D6570R00001
Research Site
Remscheid, D6570r00001, D6570R00001
Research Site
Reutlingen, D6570r00001, D6570R00001
Research Site
Rosenheim, D6570r00001, D6570R00001
Research Site
Rostock, D6570r00001, D6570R00001
Research Site
Roth, D6570r00001, D6570R00001
Research Site
Rüdersdorf, D6570r00001, D6570R00001
Research Site
Rüsselsheim am Main, D6570r00001, D6570R00001
Research Site
Rust, D6570r00001, D6570R00001
Research Site
Saalfeld, D6570r00001, D6570R00001
Research Site
Saarbrücken, D6570r00001, D6570R00001
Research Site
Saarlouis, D6570r00001, D6570R00001
Research Site
Schleswig, D6570r00001, D6570R00001
Research Site
Schmölln, D6570r00001, D6570R00001
Research Site
Schönbrunn, D6570r00001, D6570R00001
Research Site
Schwedt, D6570r00001, D6570R00001
Research Site
Siegen, D6570r00001, D6570R00001
Research Site
Simmern, D6570r00001, D6570R00001
Research Site
Solingen, D6570r00001, D6570R00001
Research Site
Sonsbeck, D6570r00001, D6570R00001
Research Site
Spiesen, D6570r00001, D6570R00001
Research Site
Spremberg, D6570r00001, D6570R00001
Research Site
Steinhagen, D6570r00001, D6570R00001
Research Site
Straßkirchen, D6570r00001, D6570R00001
Research Site
Strausberg, D6570r00001, D6570R00001
Research Site
Stuttgart, D6570r00001, D6570R00001
Research Site
Sulzberg, D6570r00001, D6570R00001
Research Site
Teterow, D6570r00001, D6570R00001
Research Site
Teuchern, D6570r00001, D6570R00001
Research Site
Thaleischweiler-Fröschen, D6570r00001, D6570R00001
Research Site
Trier, D6570r00001, D6570R00001
Research Site
Ulm, D6570r00001, D6570R00001
Research Site
Unterwellenborn, D6570r00001, D6570R00001
Research Site
Ursensollen, D6570r00001, D6570R00001
Research Site
Voerde, D6570r00001, D6570R00001
Research Site
Wallenhorst, D6570r00001, D6570R00001
Research Site
Wardenburg, D6570r00001, D6570R00001
Research Site
Waren, D6570r00001, D6570R00001
Research Site
Warendorf, D6570r00001, D6570R00001
Research Site
Wehrheim, D6570r00001, D6570R00001
Research Site
Weilheim, D6570r00001, D6570R00001
Research Site
Weißenburg, D6570r00001, D6570R00001
Research Site
Weißwasser, D6570r00001, D6570R00001
Research Site
Wiesbaden, D6570r00001, D6570R00001
Research Site
Witten, D6570r00001, D6570R00001
Research Site
Wittenberg, D6570r00001, D6570R00001
Research Site
Worms, D6570r00001, D6570R00001
Research Site
Wuppertal, D6570r00001, D6570R00001
Research Site
Zwönitz, D6570r00001, D6570R00001

Other trials in Germany

About this study

Official title: Non-interventional Study for Documentation of the Therapeutic Efficacy, Use and Tolerance of the Fixed-Dose Combinations (FDC) Duaklir® Genuair® (Aclidinium/Formoterol), Ultibro® Breezhaler® (Glycopyrronium/Indacaterol) and Anoro® (Umeclidinium/Vilanterol) in the Treatment of COPD Under Real Conditions in the Practices of Pneumologists, Internists, and General Practitioners

Read the detailed description

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: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, Fixed-dose Combination, LAMA/LABA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists), Inhaler, Aclidinium/Formoterol, Glycopyrronium/Indacaterol, Umeclidinium/Vilanterol
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.

Study groups in NCT02552160
Study group	Role	What they receive
Patients on Duaklir® Genuair®		Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol)
Patients on Ultibro® Breezhaler®		Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol)
Patients on Anoro®		Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol)

What is being measured

The primary outcome is the main question the study is designed to answer.

Lung function
Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity)
Measured: First visit (baseline)
Number of patients with concomitant diseases classified by diagnostic subgroups
Measured: First visit (baseline)
Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups
Measured: First visit (baseline)
Number of patients with exacerbations within the previous 24 months
History of previous exacerbations that will be collected at first observational visit.
Measured: First visit (baseline)

Secondary outcomes (7)

Change in well-being and quality of life
CAT (COPD Assessment Test™) questionnaire will be completed at each visit, approximately every 3 months.
Measured: First visit (baseline) to end of observational period at 12 months
Effect on the severity of the shortness of breath
mMRC (modified Medical Research Council Dyspnea Scale) questionnaire will be completed at each visit, approximately every 3 months.
Measured: First visit (baseline) to end of observational period at 12 months
Change in the night-time and early-morning COPD symptoms
NiSCI/EMSCI (Night-time symptoms of COPD Instrument / Early-morning symptoms of COPD instrument) questionnaire will be completed at each visit, approximately every 3 months.
Measured: First visit (baseline) to end of observational period at 12 months
Lung function
Assessment of FEV1, FVC at each visit, approximately every 3 months.
Measured: First visit (baseline) to end of observational period at 12 months
Number of exacerbations by grade
Number of exacerbations will be collected at each visit, approximately every 3 months
Measured: First visit (baseline) to end of observational period at 12 months
Adverse events
Adverse events will be collected at each visit, approximately every 3 months.
Measured: First visit (baseline) to end of observational period at 12 months
Handling of inhaler
Questionnaire regarding handling of inhaler by patient
Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201531 Dec 2017

First posted17 Sep 2015 (estimated)
Study start24 Sep 2015
Primary completion31 Dec 2017
Study completion31 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Case-control
Time perspective: Other
Enrolment: 3,732 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT02552160
Sponsor's protocol ID: D6570R00001
Acronym: DETECT
Status last verified: Dec 2018
First submitted: 29 Jul 2015
Last updated: 11 Dec 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Study for Documentation of the Therapeutic Efficacy, Use and Tolerance of the Fixed-Dose Combinations (FDC) Duaklir® Genuair® (Aclidinium/Formoterol), Ultibro® Breezhaler® (Glycopyrronium/Indacaterol) and Anoro® (Umeclidinium/Vilanterol) in the Treatment of COPD Under Real Conditions in the Practices of Pneumologists, Internists, and General Practitioners
ClinicalTrials.gov ID: NCT02552160
Acronym / sponsor ID: DETECT / D6570R00001
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, Fixed-dose Combination, LAMA/LABA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists), Inhaler, Aclidinium/Formoterol, Glycopyrronium/Indacaterol, Umeclidinium/Vilanterol
Study type: Observational
Recruitment status: Completed
Enrolment: 3,732 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 24 Sep 2015 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 17 Sep 2015 (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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Other
Target follow-up: 12 Months
Number of arms: 3

Arm	Type	Receives
Patients on Duaklir® Genuair®	–	–Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol)
Patients on Ultibro® Breezhaler®	–	–Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol)
Patients on Anoro®	–	–Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol)

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who have been diagnosed with COPD (Chronic obstructive pulmonary disease), who have been changed over within the last 3 months to one of the 3 listed fixed-dose combinations (FDC) or for whom such a changeover is intended, and whose lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover are available (within the last 6 months) or are determined at the time of the 1st visit, if this is planned as part of the routine treatment.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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.

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

Lung function
Time frame: First visit (baseline)
Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity)
Number of patients with concomitant diseases classified by diagnostic subgroups
Time frame: First visit (baseline)
Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups
Time frame: First visit (baseline)
Number of patients with exacerbations within the previous 24 months
Time frame: First visit (baseline)
History of previous exacerbations that will be collected at first observational visit.

7 secondary outcomes

Change in well-being and quality of life
Time frame: First visit (baseline) to end of observational period at 12 months
Effect on the severity of the shortness of breath
Time frame: First visit (baseline) to end of observational period at 12 months
Change in the night-time and early-morning COPD symptoms
Time frame: First visit (baseline) to end of observational period at 12 months
Lung function
Time frame: First visit (baseline) to end of observational period at 12 months
Number of exacerbations by grade
Time frame: First visit (baseline) to end of observational period at 12 months
Adverse events
Time frame: First visit (baseline) to end of observational period at 12 months
Handling of inhaler
Time frame: At 12 months

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 11 Dec 2018.
CSR SynopsisLink provided by the sponsor.

Related trials for Chronic Obstructive Pulmonary Disease

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders

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.

The record lists no contact. Use the official record to reach the sponsor.

180 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 180 sites in Germany.

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 5 inclusion and 4 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung function (time frame: First visit (baseline)). The study lists 4 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 NCT02552160.

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 11 Dec 2018.