N/A
Completed N=1,253
ADESPI: Adherence to Spiriva® in Patients With COPD (Chronic Obstructive Pulmonary Disease), Measured by Morisky-8 (MMAS-8) Scale, in Routine Medical Practice
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01388166 ↗
Enrolled (actual)
1,253
Serious AEs
4.7%
Results posted
Dec 2014
Primary outcomePrimary: Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline — 0.6 units on a scale — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline |
0.6 | <0.0001 sig |
| SECONDARY Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months. |
0.2 | 0.0002 sig |
| SECONDARY Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline |
0.7 | <0.0001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01388166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.