ADESPI: Adherence to Spiriva® in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice

NCT01388166

Last updated date
Study Location
Boehringer Ingelheim Investigational Site 58
Baja, , , Hungary
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
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
 (submitted: November 28, 2014)
1253
Original Estimated Enrollment
 (submitted: July 4, 2011)
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:

  • 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

Exclusion criteria:

  • 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.
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 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
Study Chair:Boehringer IngelheimBoehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date November 2014