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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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01388166
First received: July 1, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


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 & Eastern European Region

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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 ]

Enrollment: 1261
Study Start Date: September 2011
Study Completion Date: December 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01388166     History of Changes
Other Study ID Numbers: 205.483
Study First Received: July 1, 2011
Last Updated: January 20, 2014
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014