Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Pfizer
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01036763
First received: December 18, 2009
Last updated: July 10, 2012
Last verified: July 2012
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Purpose
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).
| Condition |
|---|
|
Pulmonary Disease, Chronic Obstructive |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Assessment of COPD Therapy From the Physicians Perspective Using Tiotropium as an Example |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Tiotropium bromide
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Success of Treatment With Tiotropium According to Physician's Assessment [ Time Frame: 6 - 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
- Assessment of Tolerability According to Patient [ Time Frame: 6 - 12 weeks ] [ Designated as safety issue: No ]Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Secondary Outcome Measures:
- Physician's Global Evaluation at Visit 1 [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Study Start Date: | January 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Study Design:
observational
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036763
Show 352 Study Locations
Show 352 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Pfizer
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01036763 History of Changes |
| Other Study ID Numbers: | 205.455 |
| Study First Received: | December 18, 2009 |
| Results First Received: | February 15, 2012 |
| Last Updated: | July 10, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Tiotropium Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013