Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example
NCT01036763
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COPD patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines
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.
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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 * |
| |||
* 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 | 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 |
| |||
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 |
| |||
PRS Account | Boehringer Ingelheim | |||
Verification Date | February 2014 |