Pulmonary Disease, Chronic Obstructive Clinical Trial
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®
Verified date | April 2015 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
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).
Status | Completed |
Enrollment | 1845 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion criteria: - 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) Exclusion criteria: - 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 |
Observational Model: Cohort, Time Perspective: Prospective
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Germany | Boehringer Ingelheim Investigational Site 1 | Aachen | |
Germany | Boehringer Ingelheim Investigational Site 2 | Ahaus | |
Germany | Boehringer Ingelheim Investigational Site 3 | Aichtal | |
Germany | Boehringer Ingelheim Investigational Site 4 | Aldenhoven | |
Germany | Boehringer Ingelheim Investigational Site 5 | Alfeld | |
Germany | Boehringer Ingelheim Investigational Site 6 | Altötting | |
Germany | Boehringer Ingelheim Investigational Site 7 | Ansbach | |
Germany | Boehringer Ingelheim Investigational Site 10 | Asbach-Bäumenheim | |
Germany | Boehringer Ingelheim Investigational Site 8 | Asbach-Bäumenheim | |
Germany | Boehringer Ingelheim Investigational Site 9 | Asbach-Bäumenheim | |
Germany | Boehringer Ingelheim Investigational Site 11 | Aßlar | |
Germany | Boehringer Ingelheim Investigational Site 12 | Auerbach | |
Germany | Boehringer Ingelheim Investigational Site 13 | Auerbach | |
Germany | Boehringer Ingelheim Investigational Site 14 | Auerbach | |
Germany | Boehringer Ingelheim Investigational Site 15 | Augsburg | |
Germany | Boehringer Ingelheim Investigational Site 16 | Augsburg | |
Germany | Boehringer Ingelheim Investigational Site 17 | Bacharach | |
Germany | Boehringer Ingelheim Investigational Site 18 | Bad Friedrichshall | |
Germany | Boehringer Ingelheim Investigational Site 19 | Bad Krozingen | |
Germany | Boehringer Ingelheim Investigational Site 20 | Bad Langensalza | |
Germany | Boehringer Ingelheim Investigational Site 21 | Bad Lippspringe | |
Germany | Boehringer Ingelheim Investigational Site 22 | Bad Lippspringe | |
Germany | Boehringer Ingelheim Investigational Site 23 | Bad Reichenhall | |
Germany | Boehringer Ingelheim Investigational Site 24 | Bad Sachsa | |
Germany | Boehringer Ingelheim Investigational Site 25 | Bad Soden | |
Germany | Boehringer Ingelheim Investigational Site 26 | Bad Soden-Salmünster | |
Germany | Boehringer Ingelheim Investigational Site 27 | Bad Windsheim | |
Germany | Boehringer Ingelheim Investigational Site 28 | Bad Wörishofen | |
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Germany | Boehringer Ingelheim Investigational Site 31 | Beelitz-Heilstätten | |
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Germany | Boehringer Ingelheim Investigational Site 189 | Frankfurt | |
Germany | Boehringer Ingelheim Investigational Site 190 | Frankfurt | |
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Germany | Boehringer Ingelheim Investigational Site 192 | Frankfurt | |
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Germany | Boehringer Ingelheim Investigational Site 200 | Friedrichshafen | |
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Germany | Boehringer Ingelheim Investigational Site 203 | Fürstenwalde | |
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Germany | Boehringer Ingelheim Investigational Site 205 | Fürth | |
Germany | Boehringer Ingelheim Investigational Site 206 | Gailsdorf | |
Germany | Boehringer Ingelheim Investigational Site 207 | Gangkofen | |
Germany | Boehringer Ingelheim Investigational Site 208 | Garmisch-Partenkirchen | |
Germany | Boehringer Ingelheim Investigational Site 209 | Garmisch-Partenkirchen | |
Germany | Boehringer Ingelheim Investigational Site 210 | Gauting | |
Germany | Boehringer Ingelheim Investigational Site 211 | Gelnhausen | |
Germany | Boehringer Ingelheim Investigational Site 212 | Gelsenkirchen | |
Germany | Boehringer Ingelheim Investigational Site 213 | Gelsenkirchen | |
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Germany | Boehringer Ingelheim Investigational Site 215 | Gelsenkirchen | |
Germany | Boehringer Ingelheim Investigational Site 216 | Gelsenkirchen | |
Germany | Boehringer Ingelheim Investigational Site 217 | Gelsenkirchen | |
Germany | Boehringer Ingelheim Investigational Site 218 | Gelsenkirchen | |
Germany | Boehringer Ingelheim Investigational Site 219 | Geltow | |
Germany | Boehringer Ingelheim Investigational Site 220 | Geretsried | |
Germany | Boehringer Ingelheim Investigational Site 221 | Germersheim | |
Germany | Boehringer Ingelheim Investigational Site 222 | Gevelsberg | |
Germany | Boehringer Ingelheim Investigational Site 223 | Goslar | |
Germany | Boehringer Ingelheim Investigational Site 224 | Gräfeling | |
Germany | Boehringer Ingelheim Investigational Site 225 | Greußen | |
Germany | Boehringer Ingelheim Investigational Site 226 | Grevesmühlen | |
Germany | Boehringer Ingelheim Investigational Site 227 | Grimma | |
Germany | Boehringer Ingelheim Investigational Site 228 | Großrosseln | |
Germany | Boehringer Ingelheim Investigational Site 229 | Gummersbach | |
Germany | Boehringer Ingelheim Investigational Site 230 | Gundelfingen | |
Germany | Boehringer Ingelheim Investigational Site 231 | Gütersloh | |
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Germany | Boehringer Ingelheim Investigational Site 240 | Halberstadt | |
Germany | Boehringer Ingelheim Investigational Site 241 | Haldensleben | |
Germany | Boehringer Ingelheim Investigational Site 242 | Haldensleben | |
Germany | Boehringer Ingelheim Investigational Site 243 | Halle | |
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Germany | Boehringer Ingelheim Investigational Site 246 | Halle | |
Germany | Boehringer Ingelheim Investigational Site 247 | Halle / Saale | |
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Germany | Boehringer Ingelheim Investigational Site 393 | Lübeck | |
Germany | Boehringer Ingelheim Investigational Site 394 | Lübeck-Travemünde | |
Germany | Boehringer Ingelheim Investigational Site 395 | Luckenwalde | |
Germany | Boehringer Ingelheim Investigational Site 396 | Luckenwalde | |
Germany | Boehringer Ingelheim Investigational Site 397 | Lüdenscheid | |
Germany | Boehringer Ingelheim Investigational Site 398 | Lüdenscheid | |
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Germany | Boehringer Ingelheim Investigational Site 413 | Mannheim | |
Germany | Boehringer Ingelheim Investigational Site 414 | Mannheim | |
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Germany | Boehringer Ingelheim Investigational Site 449 | München | |
Germany | Boehringer Ingelheim Investigational Site 450 | München | |
Germany | Boehringer Ingelheim Investigational Site 451 | München | |
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Germany | Boehringer Ingelheim Investigational Site 472 | Nienburg | |
Germany | Boehringer Ingelheim Investigational Site 473 | Niesky | |
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Germany | Boehringer Ingelheim Investigational Site 482 | Nürnberg | |
Germany | Boehringer Ingelheim Investigational Site 483 | Nürnberg | |
Germany | Boehringer Ingelheim Investigational Site 484 | Nürnberg | |
Germany | Boehringer Ingelheim Investigational Site 485 | Nürnberg | |
Germany | Boehringer Ingelheim Investigational Site 486 | Nürnberg | |
Germany | Boehringer Ingelheim Investigational Site 487 | Nürnberg | |
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Germany | Boehringer Ingelheim Investigational Site 674 | Wiesloch | |
Germany | Boehringer Ingelheim Investigational Site 675 | Wiesloch | |
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Germany | Boehringer Ingelheim Investigational Site 680 | Wilhelmshaven | |
Germany | Boehringer Ingelheim Investigational Site 681 | Wilhelmshaven | |
Germany | Boehringer Ingelheim Investigational Site 682 | Willich | |
Germany | Boehringer Ingelheim Investigational Site 683 | Winhönng | |
Germany | Boehringer Ingelheim Investigational Site 684 | Witten | |
Germany | Boehringer Ingelheim Investigational Site 685 | Witten | |
Germany | Boehringer Ingelheim Investigational Site 686 | Witten | |
Germany | Boehringer Ingelheim Investigational Site 687 | Witten | |
Germany | Boehringer Ingelheim Investigational Site 688 | Wittenberg | |
Germany | Boehringer Ingelheim Investigational Site 689 | Wittenberg | |
Germany | Boehringer Ingelheim Investigational Site 690 | Wolfenbüttel | |
Germany | Boehringer Ingelheim Investigational Site 691 | Wolfsburg | |
Germany | Boehringer Ingelheim Investigational Site 692 | Wolfsburg | |
Germany | Boehringer Ingelheim Investigational Site 693 | Wolfsburg | |
Germany | Boehringer Ingelheim Investigational Site 694 | Wolfsburg | |
Germany | Boehringer Ingelheim Investigational Site 695 | Wolfsburg - Fallersleben | |
Germany | Boehringer Ingelheim Investigational Site 696 | Wörth | |
Germany | Boehringer Ingelheim Investigational Site 697 | Wörth | |
Germany | Boehringer Ingelheim Investigational Site 698 | Wuppertal | |
Germany | Boehringer Ingelheim Investigational Site 699 | Zellertal | |
Germany | Boehringer Ingelheim Investigational Site 700 | Zerbst | |
Germany | Boehringer Ingelheim Investigational Site 701 | Zirndorf | |
Germany | Boehringer Ingelheim Investigational Site 702 | Zirndorf | |
Germany | Boehringer Ingelheim Investigational Site 703 | Zweibrücken |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with "therapeutic success" (= 10-point increase in the PF-10 score between Visit 1 (initial examination) and Visit 2 (after 4 to 6 weeks). | up to 6 weeks | No | |
Secondary | Absolute changes in the PF-10 score | up to 6 weeks | No | |
Secondary | General condition of the patient: evaluation by the doctor (PGE score) at Visit 1 (initial examination) and at the end of the study (Visit 2) | up to 6 weeks | No | |
Secondary | Patient satisfaction with Spiriva Repimat plus Striverdi Respimat or Spiriva 18 Mikrogramm plus Striverdi Respimat at the end of the study | up to 6 weeks | No |
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