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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615992
First received: January 24, 2008
Last updated: May 18, 2012
Last verified: May 2012

January 24, 2008
May 18, 2012
April 2007
April 2008   (final data collection date for primary outcome measure)
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)
Activities of daily living score after 21 to 28 days of treatment with Tiotropium [ Time Frame: 21 to 28 days ]
Complete list of historical versions of study NCT00615992 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
dyspnea score after 21 to 28 days of treatment with Tiotropium assessment of efficacy and tolerability on 4 point scale [ Time Frame: 21 to 28 days ]
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Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
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.

Not Provided
Observational
Observational Model: Cohort
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Probability Sample

primary care

Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
754
Not Provided
April 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00615992
205.398
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP