ADESPI: Adherence to Spiriva® in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice
NCT01388166
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- Male and female ambulatory outpatients being seen in a participating physicians office for routine care,
- Patients with a clinical diagnosis of COPD and already being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium (Spiriva® HandiHaler® or Respimat®) at least 1 month and within product label
- Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone
- Uncooperative patients as judged by the physician
- Patients with any conditions excluded as per Country specific package insert
- Patients currently enrolled in any clinical trial which requires a change in
medication for their respiratory problems.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title | ADESPI: Adherence to Spiriva® in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice | |||
Official Title | ADESPI: Adherence to Spiriva® in Patients With COPD, Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice in Central & Eastern European Region | |||
Brief Summary | The objective of this observational study is to collect and evaluate data on medication adherence of patients on maintenance COPD therapy with long-acting anticholinergic (e.g. Spiriva® delivered by HandiHaler® or Respimat®) using the MMAS-8 questionnaire. | |||
Detailed Description | Purpose: | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | COPD | |||
Condition | Pulmonary Disease, Chronic Obstructive | |||
Intervention | Procedure: Education
Education | |||
Study Groups/Cohorts | Patients with COPD
Intervention: Procedure: Education | |||
Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment | 1253 | |||
Original Estimated Enrollment | 1250 | |||
Actual Study Completion Date | December 2013 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion criteria:
Exclusion criteria:
| |||
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 | Hungary, Slovakia, Slovenia | |||
Removed Location Countries | Ukraine | |||
Administrative Information | ||||
NCT Number | NCT01388166 | |||
Other Study ID Numbers | 205.483 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Boehringer Ingelheim | |||
Study Sponsor | Boehringer Ingelheim | |||
Collaborators | Pfizer | |||
Investigators |
| |||
PRS Account | Boehringer Ingelheim | |||
Verification Date | November 2014 |