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Observational Non-Interventional Study With Spiriva Respimat in COPD Patients

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ClinicalTrials.gov Identifier: NCT00699699
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : March 12, 2010
Last Update Posted : April 10, 2014
Sponsor:
Information provided by:

Study Description
Brief Summary:
This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients on treatment with Spiriva Respimat and allows adverse events to be recorded and evaluated.

Condition or disease
Pulmonary Disease, Chronic Obstructive

Study Design

Study Type : Observational
Actual Enrollment : 1280 participants
Time Perspective: Prospective
Official Title: Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®
Study Start Date : June 2008
Primary Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks [ Time Frame: Baseline and after 6 weeks of treatment ]
    Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)


Secondary Outcome Measures :
  1. Change From Baseline in the PF-10 Score After 6 Weeks [ Time Frame: Baseline and after 6 weeks of treatment ]
    Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)

  2. Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety [ Time Frame: Baseline and after 6 weeks of treatment ]
    Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications "poor" (1, 2), "satisfactory" (3, 4), "good" (5, 6), and "excellent" (7, 8))

  3. Patients' Satisfaction After 6 Weeks of Treatment [ Time Frame: 6 weeks ]
    Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment ("very satisfied", "satisfied", "rather satisfied", "neither satisfied nor "unsatisfied", "rather unsatisfied", "unsatisfied", and "very unsatisfied")


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients
Criteria

Inclusion Criteria:

COPD patients who require treatment with longacting anticholinergic

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. Spiriva® Respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.

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): NCT00699699


  Show 188 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00699699     History of Changes
Other Study ID Numbers: 205.426
First Posted: June 18, 2008    Key Record Dates
Results First Posted: March 12, 2010
Last Update Posted: April 10, 2014
Last Verified: March 2014

Keywords provided by Boehringer Ingelheim:
Chronic Obstructive Pulmonary Disease (COPD)

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