Pulmonary Disease, Chronic ObstructiveNCT02173769

Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 701 sites in Germany.

Completed

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

Trial summary

The decrease in physical activity due to increasing dyspnoea that over time leads to a steadily worsening condition and increasing restriction of physical functioning is a key problem for COPD patients and affects even the early stages. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Spiriva® Respimat® and Striverdi® Respimat®
How many people: 1,845 participants
Where: 701 sitesGermany
Study dates: Jun 2014to Mar 2015
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients

Who may be able to join

Female and male patients >= 40 years
COPD GOLD 2014 B - D
Treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat® acc. to the Summary of Product Characteristics (SmPC), no change of routine diagnostics and treatment
Signed informed consent form before inclusion into the non-interventional study (NIS)

Who cannot join

Patients with contraindications acc. to the Summary of Product Characteristics (SmPC)
pregnant and breastfeeding women
patients who are taking part in a different non-interventional study (NIS) or an interventional clinical study at the same time are not to be enrolled

Trial locations and contacts

701 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Germany300 sites

Boehringer Ingelheim Investigational Site 1
Aachen
Boehringer Ingelheim Investigational Site 2
Ahaus
Boehringer Ingelheim Investigational Site 3
Aichtal
Boehringer Ingelheim Investigational Site 4
Aldenhoven
Boehringer Ingelheim Investigational Site 5
Alfeld
Boehringer Ingelheim Investigational Site 6
Altötting
Boehringer Ingelheim Investigational Site 7
Ansbach
Boehringer Ingelheim Investigational Site 10
Asbach-Bäumenheim
Boehringer Ingelheim Investigational Site 8
Asbach-Bäumenheim
Boehringer Ingelheim Investigational Site 9
Asbach-Bäumenheim
Boehringer Ingelheim Investigational Site 11
Aßlar
Boehringer Ingelheim Investigational Site 12
Auerbach
Boehringer Ingelheim Investigational Site 13
Auerbach
Boehringer Ingelheim Investigational Site 14
Auerbach
Boehringer Ingelheim Investigational Site 15
Augsburg
Boehringer Ingelheim Investigational Site 16
Augsburg
Boehringer Ingelheim Investigational Site 17
Bacharach
Boehringer Ingelheim Investigational Site 18
Bad Friedrichshall
Boehringer Ingelheim Investigational Site 19
Bad Krozingen
Boehringer Ingelheim Investigational Site 20
Bad Langensalza
Boehringer Ingelheim Investigational Site 21
Bad Lippspringe
Boehringer Ingelheim Investigational Site 22
Bad Lippspringe
Boehringer Ingelheim Investigational Site 23
Bad Reichenhall
Boehringer Ingelheim Investigational Site 24
Bad Sachsa
Boehringer Ingelheim Investigational Site 25
Bad Soden
Boehringer Ingelheim Investigational Site 26
Bad Soden-Salmünster
Boehringer Ingelheim Investigational Site 27
Bad Windsheim
Boehringer Ingelheim Investigational Site 28
Bad Wörishofen
Boehringer Ingelheim Investigational Site 29
Baden-Baden
Boehringer Ingelheim Investigational Site 30
Balingen
Boehringer Ingelheim Investigational Site 31
Beelitz-Heilstätten
Boehringer Ingelheim Investigational Site 32
Beelitz-Heilstätten
Boehringer Ingelheim Investigational Site 33
Bensheim
Boehringer Ingelheim Investigational Site 34
Bensheim
Boehringer Ingelheim Investigational Site 35
Berkatal-Frankershausen
Boehringer Ingelheim Investigational Site 36
Berlin
Boehringer Ingelheim Investigational Site 37
Berlin
Boehringer Ingelheim Investigational Site 38
Berlin
Boehringer Ingelheim Investigational Site 39
Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Berlin
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Bernkastel
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Biberach
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Biberach
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Biberach
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Bielefeld
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Bielefeld
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Blankenheim
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Bocholt
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Bocholt
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Bochum
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Bockenheim
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Bodenwerder
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Bonn
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Bonn
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Bonn
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Bonn
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Bonn
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Bottrop
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Bottrop
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Brandenburg
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Braunschweig
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Bremen
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Bremen
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Bremen
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Bremen
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Bremen
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Bruchsal
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Bruchweiler-Bärenbach
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Buchbach
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Bünde
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Bünde
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Burg
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Burg
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Burgheim
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Burgstädt
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Cham
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Chemnitz
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Chemnitz
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Chemnitz
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Claußnitz
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Cloppenburg
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Coburg
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Cologne
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Cologne
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Cottbus
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Cottbus
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Cottbus
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Darmstadt
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Deggendorf
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Delitzsch
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Delitzsch
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Dessau
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Dessau
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Dessau
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Dortmund
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Dortmund
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Dortmund
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Dortmund
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Dortmund
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Dortmund
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Drensteinfurt
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Dresden
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Dudenhofen
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Duisburg
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Duisburg
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Duisburg
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Duisburg
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Duisburg
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Duisburg
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Duisburg
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Düsseldorf
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Düsseldorf
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Düsseldorf
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Düsseldorf
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Düsseldorf
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Ehrenkirchen
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Eisenach
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Eisenhüttenstadt
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Ellhofen
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Emmerich
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Erding
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Erfurt
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Erfurt
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Erfurt
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Erkelenz
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Erkelenz
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Erlangen
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Erlensee
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Eschborn
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Eschwege
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Essen
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Essen
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Essen
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Essen
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Essen
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Essen
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Essen-Werden
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Euskirchen
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Euskirchen
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Eutin
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Eutin
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Eutin
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Falkensee
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Filderstadt
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Finsterwalde
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Flensburg
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Forchheim
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Forchheim
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Forchheim
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Forchheim
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Forchheim
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Framersheim
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Frankfurt
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Frankfurt
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Frankfurt
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Frankfurt
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Frankfurt
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Frankfurt
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Frankfurt am Main
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Freiberg
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Freiberg
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Freising
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Freising
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Freital
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Freital
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Friedrichshafen
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Friedrichsthal
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Friedrichsthal
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Fürstenwalde
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Fürstenwalde
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Fürth
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Gailsdorf
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Gangkofen
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Garmisch-Partenkirchen
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Garmisch-Partenkirchen
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Gauting
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Gelnhausen
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Gelsenkirchen
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Gelsenkirchen
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Gelsenkirchen
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Geltow
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Geretsried
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Germersheim
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Gevelsberg
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Goslar
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Gräfeling
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Greußen
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Grevesmühlen
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Grimma
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Großrosseln
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Gummersbach
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Gundelfingen
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Gütersloh
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Hagen
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Hagen
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Hagen
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Halberstadt
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Haldensleben I
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Haldensleben I
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Halle
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Hallstadt
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamburg
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Hamelin
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Hanerau-Hademarschen
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Hanover
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Hanover
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Hanover
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Hartha
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Hartha
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Heide
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Heidelberg
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Heidelberg
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Heidelberg
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Heidelberg
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Heidelberg
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Heilbronn
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Heilbronn
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Heilbronn
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Heilbronn
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Heilbronn
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Heinsberg-Karken
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Hellenthal
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Hellersdorf
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Hellersdorf
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Helmstedt
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Hemmingen
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Hemmingen
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Hemmingen
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Hemmingen
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Hemsbach
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Hemsbach

Other trials in Germany

About this study

Official title: AKTIV: Changes in Physical Functioning in Patients With COPD During Therapy With a Combination of Spiriva® Respimat® + Striverdi® Respimat® or Spiriva® 18 Mikrogramm + Striverdi® Respimat®

Clinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a marked improvement in physical exercise capacity.

However, there have so far been no data from the daily practice setting about everyday functioning on combination treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in patients requiring treatment with 2 long-acting bronchodilators.

The objective of this NIS is to measure changes in physical functioning as a surrogate for physical activity and exercise capacity in COPD patients on treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in routine daily treatment (so-called real life setting).

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Spiriva® Respimat®, Striverdi® Respimat®
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.

Spiriva® Respimat®Drug
Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®
Striverdi® Respimat®Drug
Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®

Study groups in NCT02173769
Study group	Role	What they receive
Adults with COPD		Not described Receives: Drug: Spiriva® Respimat®; Drug: Striverdi® Respimat®

What is being measured

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

Percentage of Participants With "Therapeutic Success"
Percentage of participants with "therapeutic success" defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks.
The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.
Measured: Baseline and 4-6 weeks

Secondary outcomes (6)

Absolute Changes in the PF-10 Score
Absolute changes in the PF-10 score.
The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.
Measured: 4-6 weeks
General Health of the Patient at Baseline
General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination.
The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent).
Measured: Baseline
General Health of the Patient After 4-6 Weeks
General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks.
The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent).
Measured: 4-6 weeks
Patient Satisfaction: Overall Satisfaction
Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.
Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).
Measured: 4-6 weeks
Patient Satisfaction: Satisfaction With Inhaler
Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.
Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).
Measured: 4-6 weeks
Patient Satisfaction: Satisfaction With Handling of Inhaler
Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.
Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).
Measured: 4-6 weeks

Timeline

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

Jun 2014Mar 2015

First posted25 Jun 2014 (estimated)
Study startJun 2014
Primary completionMar 2015
Study completionMar 2015

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.
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: 1,845 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02173769
Sponsor's protocol ID: 1222.56
Status last verified: Apr 2017
First submitted: 24 Jun 2014
Last updated: 5 Jun 2017
Results posted: Yes, on ClinicalTrials.gov

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?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AKTIV: Changes in Physical Functioning in Patients With COPD During Therapy With a Combination of Spiriva® Respimat® + Striverdi® Respimat® or Spiriva® 18 Mikrogramm + Striverdi® Respimat®
ClinicalTrials.gov ID: NCT02173769
Acronym / sponsor ID: 1222.56
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 1,845 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 25 Jun 2014 (estimated)
Results: Posted 1 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Clinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a marked improvement in physical exercise capacity.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Adults with COPD	–	Drug: Spiriva® Respimat®, Drug: Striverdi® Respimat®

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients

Key inclusion criteria (4 listed)

Female and male patients >= 40 years
COPD GOLD 2014 B - D
Treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat® acc. to the Summary of Product Characteristics (SmPC), no change of routine diagnostics and treatment
Signed informed consent form before inclusion into the non-interventional study (NIS)

Key exclusion criteria (3 listed)

Patients with contraindications acc. to the Summary of Product Characteristics (SmPC)
pregnant and breastfeeding women
patients who are taking part in a different non-interventional study (NIS) or an interventional clinical study at the same time are not to be enrolled

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
Spiriva® Respimat®Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®	Drug	Adults with COPD
Striverdi® Respimat®Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®	Drug	Adults with COPD

Primary outcome

Percentage of Participants With "Therapeutic Success"
Time frame: Baseline and 4-6 weeks
Percentage of participants with "therapeutic success" defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks. The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.

6 secondary outcomes

Absolute Changes in the PF-10 Score
Time frame: 4-6 weeks
General Health of the Patient at Baseline
Time frame: Baseline
General Health of the Patient After 4-6 Weeks
Time frame: 4-6 weeks
Patient Satisfaction: Overall Satisfaction
Time frame: 4-6 weeks
Patient Satisfaction: Satisfaction With Inhaler
Time frame: 4-6 weeks
Patient Satisfaction: Satisfaction With Handling of Inhaler
Time frame: 4-6 weeks

Results and safety

Results posted to the registry on 1 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients	1,858	1,854

Primary outcome: Percentage of Participants With "Therapeutic Success"

Time frame: Baseline and 4-6 weeks. Number. Unit: Percentage of participants

Measure	All Patients n = 1726
Therapy successful	48.90
Therapy not successful	51.10

Population analysed: Full analysis (FAS) which includes all patients enrolled in the study who did not violated any inclusion or exclusion criteria.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spiriva Respimat + Striverdi Respimat	30 of 1,298 (2.3%)	0 of 1,298 (0%)	Not reported
Spiriva 18 mcg + Striverdi Respimat	12 of 560 (2.1%)	0 of 560 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 701 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 4 inclusion and 3 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 701 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?

Yes. Results are posted in the registry (first posted 1 Apr 2016). 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?

Percentage of Participants With "Therapeutic Success" (time frame: Baseline and 4-6 weeks). 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 NCT02173769.

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 5 Jun 2017.