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Trial record 1 of 1 for:    NCT01036763
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Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example

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ClinicalTrials.gov Identifier: NCT01036763
Recruitment Status : Completed
First Posted : December 21, 2009
Results First Posted : March 22, 2012
Last Update Posted : March 27, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date December 18, 2009
First Posted Date December 21, 2009
Results First Submitted Date February 15, 2012
Results First Posted Date March 22, 2012
Last Update Posted Date March 27, 2014
Study Start Date January 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2012)
  • Success of Treatment With Tiotropium According to Physician's Assessment [ Time Frame: 6 - 12 weeks ]
    Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful
  • Assessment of Efficacy According to Physician [ Time Frame: 6 - 12 weeks ]
    Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
  • Assessment of Tolerability According to Physician [ Time Frame: 6 - 12 weeks ]
    Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
  • Assessment of Efficacy According to Patient [ Time Frame: 6 - 12 weeks ]
    patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
  • Assessment of Tolerability According to Patient [ Time Frame: 6 - 12 weeks ]
    Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Original Primary Outcome Measures
 (submitted: December 18, 2009)
Documentation of the most important outcome parameters used to assess the success of treatment with tiotropium according to physicians assessment [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures
 (submitted: April 5, 2012)
  • Physician's Global Evaluation at Visit 1 [ Time Frame: 0 weeks ]
    Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores "Poor (1, 2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)" prior to treatment with Spiriva.
  • Physician's Global Evaluation at Visit 2 [ Time Frame: after 6 - 12 weeks ]
    Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva.
Original Secondary Outcome Measures
 (submitted: December 18, 2009)
Collection of physicians assessments and patients assessments of efficacy and tolerability [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example
Official Title Assessment of COPD Therapy From the Physicians Perspective Using Tiotropium as an Example
Brief Summary

Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18 mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. Such data are not yet available.

Also collection of physicians assessments and patients assessments of efficacy and tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).

Detailed Description

Study Design:

observational

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients
Condition Pulmonary Disease, Chronic Obstructive
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • Rau-Berger H, Kroker A, Mitfessel H, Schmidt H, Glaab T Assessment of COPD-therapy with tiotropium by the treating pneumologist. 53rd Cong of the German Respiratory Society, Nuremberg, 29 Mar - 1 Apr 2012 (Poster), (2012)
  • Glaab T, Kroker A, Mitfessel H, Schmdit H, Rau-Berger H Evaluation of COPD treatment success by office-based pneumologists using the example of tiotropium. 21st Ann Cong of the European Respiratory Society (ERS), Amsterdam, 24 - 28 Sep 2011 (Poster), (2011)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Estimated Enrollment
 (submitted: December 18, 2009)
2500
Study Completion Date Not Provided
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria COPD patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01036763
Other Study ID Numbers 205.455
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Pfizer
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date February 2014