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: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Rating scale ranging from very good (best value) to not satisfactory (worst value)


Enrollment: 754
Study Start Date: April 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615992

  Show 74 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00615992     History of Changes
Other Study ID Numbers: 205.398
Study First Received: January 24, 2008
Results First Received: June 30, 2009
Last Updated: April 24, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on September 22, 2014