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NCT Number: NCT01036763

Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example

Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18 mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. Such data are not yet available.

Also collection of physicians assessments and patients assessments of efficacy and tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).

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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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 1, Ahrensburg, Germany

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About this study

Study Design:

observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

COPD patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines

Exclusion criteria

Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies.

Treatment and study plan

Primary outcomes

  1. Success of Treatment With Tiotropium According to Physician's Assessment

    Time frame: 6 - 12 weeks

    Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful

  2. Assessment of Efficacy According to Physician

    Time frame: 6 - 12 weeks

    Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined

  3. Assessment of Tolerability According to Physician

    Time frame: 6 - 12 weeks

    Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined

  4. Assessment of Efficacy According to Patient

    Time frame: 6 - 12 weeks

    patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)

  5. Assessment of Tolerability According to Patient

    Time frame: 6 - 12 weeks

    Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)

Secondary outcomes

  1. Physician's Global Evaluation at Visit 1

    Time frame: 0 weeks

    Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores "Poor (1, 2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)" prior to treatment with Spiriva.

  2. Physician's Global Evaluation at Visit 2

    Time frame: after 6 - 12 weeks

    Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Pfizer

Registry information

Official study title

Assessment of COPD Therapy From the Physicians Perspective Using Tiotropium as an Example

Important dates

Study start
2010
Primary completion
2010
First posted
Dec 21, 2009
Registry last updated
Mar 27, 2014

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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