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

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ClinicalTrials.gov Identifier: NCT02173769
Recruitment Status : Completed
First Posted : June 25, 2014
Results First Posted : April 1, 2016
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief 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.

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).


Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Spiriva® Respimat® Drug: Striverdi® Respimat®

Study Design
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Study Type : Observational
Actual Enrollment : 1845 participants
Observational Model: Cohort
Time Perspective: Prospective
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®
Study Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Adults with COPD Drug: Spiriva® Respimat®
Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Absolute Changes in the PF-10 Score [ Time Frame: 4-6 weeks ]

    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.


  2. General Health of the Patient at Baseline [ Time Frame: 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).


  3. General Health of the Patient After 4-6 Weeks [ Time Frame: 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).


  4. Patient Satisfaction: Overall Satisfaction [ Time Frame: 4-6 weeks ]

    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).


  5. Patient Satisfaction: Satisfaction With Inhaler [ Time Frame: 4-6 weeks ]

    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).


  6. Patient Satisfaction: Satisfaction With Handling of Inhaler [ Time Frame: 4-6 weeks ]

    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).



Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173769


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02173769    
Other Study ID Numbers: 1222.56
First Posted: June 25, 2014    Key Record Dates
Results First Posted: April 1, 2016
Last Update Posted: June 5, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium Bromide
Olodaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action