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Completed

NCT Number: NCT02173769

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

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).

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 1, Aachen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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®

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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®

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2014
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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