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ADESPI: Adherence to Spiriva in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice in Central 6 Eastern European Region

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01388166
First received: July 1, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

Patients having varying severities of COPD will be recruited nationally in CEE (Central and Eastern European) countries and will be observed in a real life setting over 12 months. Their MMAS-8 questionnaire results will be evaluated with regard to additional educational and disease management activities.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
 Procedure: Education

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ADESPI: Adherence to Spiriva in Patients With COPD, Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice in Central 6 Eastern European Region

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is mean change of Morisky Medication Adherence Scale -8 (MMAS-8) score at the end of the educational period after app. 6 months (Visit 3) from baseline (Visit 1) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change of Morisky Medication Adherence Scale -8 (MMAS-8) score at the end of the observational period after app. 6 months (Visit 4) from end of educational period (Visit 3). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean change of Morisky Medication Adherence Scale -8 (MMAS-8) score at the end of the observational period after app. 12 months (Visit 4) from baseline (Visit 1). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1320
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with COPD Procedure: Education
Education

Detailed Description:

Purpose:

  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

COPD

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388166

  Show 90 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Pfizer
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01388166     History of Changes
Other Study ID Numbers: 205.483
Study First Received: July 1, 2011
Last Updated: May 2, 2013
Health Authority: Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013