Clinical trial NCT02552160: DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 3732
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 of patients are selected for this therapy by physicians.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lung function
timeFrame: First visit (baseline)
measure: Number of patients with concomitant diseases classified by diagnostic subgroups
timeFrame: First visit (baseline)
measure: Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups
timeFrame: First visit (baseline)
measure: Number of patients with exacerbations within the previous 24 months
timeFrame: First visit (baseline)
Secondary outcomes:
measure: Change in well-being and quality of life
timeFrame: First visit (baseline) to end of observational period at 12 months
measure: Effect on the severity of the shortness of breath
timeFrame: First visit (baseline) to end of observational period at 12 months
measure: Change in the night-time and early-morning COPD symptoms
timeFrame: First visit (baseline) to end of observational period at 12 months
measure: Lung function
timeFrame: First visit (baseline) to end of observational period at 12 months
measure: Number of exacerbations by grade
timeFrame: First visit (baseline) to end of observational period at 12 months
measure: Adverse events
timeFrame: First visit (baseline) to end of observational period at 12 months
measure: Handling of inhaler
timeFrame: At 12 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Research Site
state: D6570r00001
city: Aldenhofen
country: Germany
facility: Research Site
state: D6570r00001
city: Aldenhoven
country: Germany
facility: Research Site
state: D6570r00001
city: Alzey
country: Germany
facility: Research Site
state: D6570r00001
city: Ansbach
country: Germany
facility: Research Site
state: D6570r00001
city: Apolda
country: Germany
facility: Research Site
state: D6570r00001
city: Aschau
country: Germany
facility: Research Site
state: D6570r00001
city: Auerbach
country: Germany
facility: Research Site
state: D6570r00001
city: Augsburg
country: Germany
facility: Research Site
state: D6570r00001
city: Bad Fallingbostel
country: Germany
facility: Research Site
state: D6570r00001
city: Bad Hersfeld
country: Germany
facility: Research Site
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city: Bad Honnef
country: Germany
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country: Germany
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city: Bad Reichenhall
country: Germany
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city: Bad Sachsa
country: Germany
facility: Research Site
state: D6570r00001
city: Bad Windsheim
country: Germany
facility: Research Site
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city: Bad Woerishofen
country: Germany
facility: Research Site
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city: Bamberg
country: Germany
facility: Research Site
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facility: Research Site
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city: Bergisch Gladbach
country: Germany
facility: Research Site
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city: Berlin
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facility: Research Site
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city: Biberach
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facility: Research Site
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city: Birkenwerder
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facility: Research Site
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city: Bitterfeld-Wolfen
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facility: Research Site
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city: Bochum
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city: Boehlen
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city: Bonn
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facility: Research Site
state: D6570r00001
city: Garching
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facility: Research Site
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city: Garmisch-Partenkirchen
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city: Gauting
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city: Gerwisch
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city: Glienicke
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city: Greiz
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city: Guetersloh
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city: Hagen
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city: Halberstadt
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city: Halle
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city: Hamburg
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city: Hannover
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city: Hartenstein
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city: Rostock
country: Germany
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city: Roth
country: Germany
facility: Research Site
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city: Ruedersdorf
country: Germany
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city: Ruesselsheim
country: Germany
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city: Rust
country: Germany
facility: Research Site
state: D6570r00001
city: Saalfeld
country: Germany
facility: Research Site
state: D6570r00001
city: Saarbruecken
country: Germany
facility: Research Site
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city: Saarlouis
country: Germany
facility: Research Site
state: D6570r00001
city: Schleswig
country: Germany
facility: Research Site
state: D6570r00001
city: Schmoelln
country: Germany
facility: Research Site
state: D6570r00001
city: Schoenbrunn
country: Germany
facility: Research Site
state: D6570r00001
city: Schwedt
country: Germany
facility: Research Site
state: D6570r00001
city: Siegen
country: Germany
facility: Research Site
state: D6570r00001
city: Simmern
country: Germany
facility: Research Site
state: D6570r00001
city: Solingen
country: Germany
facility: Research Site
state: D6570r00001
city: Sonsbeck
country: Germany
facility: Research Site
state: D6570r00001
city: Spiesen
country: Germany
facility: Research Site
state: D6570r00001
city: Spremberg
country: Germany
facility: Research Site
state: D6570r00001
city: Steinhagen
country: Germany
facility: Research Site
state: D6570r00001
city: Strasskirchen
country: Germany
facility: Research Site
state: D6570r00001
city: Strausberg
country: Germany
facility: Research Site
state: D6570r00001
city: Stuttgart
country: Germany
facility: Research Site
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city: Sulzberg
country: Germany
facility: Research Site
state: D6570r00001
city: Teterow
country: Germany
facility: Research Site
state: D6570r00001
city: Teuchern
country: Germany
facility: Research Site
state: D6570r00001
city: Thaleischweiler-Froeschen
country: Germany
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city: Trier
country: Germany
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country: Germany
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city: Unterwellenborn
country: Germany
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city: Ursensollen
country: Germany
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country: Germany
facility: Research Site
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country: Germany
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country: Germany
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country: Germany
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state: D6570r00001
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country: Germany
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country: Germany
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state: D6570r00001
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state: D6570r00001
city: Witten
country: Germany
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country: Germany
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state: D6570r00001
city: Wuppertal
country: Germany
facility: Research Site
state: D6570r00001
city: Zwoenitz
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facility: Research Site
state: D6570r00001
Study officials:
References: