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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00615992
First Posted: February 14, 2008
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  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) ]
    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) ]
    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)


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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615992


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

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00615992     History of Changes
Other Study ID Numbers: 205.398
First Submitted: January 24, 2008
First Posted: February 14, 2008
Results First Submitted: June 30, 2009
Results First Posted: December 24, 2009
Last Update Posted: February 8, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action