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Completed

NCT Number: NCT00615992

Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.

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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, Admont, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with suspected chronic obstructive pulmonary disease (COPD)
  • 3 or more positive answers in COPD questionnaire
  • Age over 40 years

Exclusion criteria

  • Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
  • Patient treated with Spiriva in the past year
  • Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics

Treatment and study plan

Tiotropium

Drug

Primary outcomes

  1. Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva

    Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

    The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)

Secondary outcomes

  1. Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva

    Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

    The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)

  2. Global Assessment of Efficacy by Patient

    Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

    Rating scale ranging from very good (best value) to not satisfactory (worst value)

  3. Global Assessment of Tolerability by Patient

    Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

    Rating scale ranging from very good (best value) to not satisfactory (worst value)

  4. Global Assessment of Efficacy by Physician

    Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

    Rating scale ranging from very good (best value) to not satisfactory (worst value)

  5. Global Assessment of Tolerability by Physician

    Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

    Rating scale ranging from very good (best value) to not satisfactory (worst value)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
First posted
Feb 14, 2008
Registry last updated
Feb 8, 2016

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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