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NCT01388166 Clinical Trial

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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01388166
Other study ID # 205.483
Secondary ID
Status Completed
Phase N/A
First received July 1, 2011
Last updated November 28, 2014
Start date September 2011
Est. completion date December 2013

Study information
Verified date November 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Hungary: National Institute of PharmacySlovakia: State Institute for Drug ControlSlovenia: Agency for Medicinal Products - Ministry of Health
Study type Observational

Clinical Trial 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.

Description:

Purpose:

Recruitment information / eligibility
Status Completed
Enrollment 1253
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Education
Education

Locations
Country Name City State
Hungary Boehringer Ingelheim Investigational Site 58 Baja
Hungary Boehringer Ingelheim Investigational Site 85 Békéscsaba
Hungary Boehringer Ingelheim Investigational Site 61 Budapest
Hungary Boehringer Ingelheim Investigational Site 62 Budapest
Hungary Boehringer Ingelheim Investigational Site 63 Budapest
Hungary Boehringer Ingelheim Investigational Site 66 Budapest
Hungary Boehringer Ingelheim Investigational Site 67 Budapest
Hungary Boehringer Ingelheim Investigational Site 68 Budapest
Hungary Boehringer Ingelheim Investigational Site 89 Budapest
Hungary Boehringer Ingelheim Investigational Site 90 Budapest
Hungary Boehringer Ingelheim Investigational Site 55 Cegléd
Hungary Boehringer Ingelheim Investigational Site 51 Debrecen
Hungary Boehringer Ingelheim Investigational Site 64 Dunakeszi
Hungary Boehringer Ingelheim Investigational Site 77 Dunaújváros
Hungary Boehringer Ingelheim Investigational Site 56 Edelény
Hungary Boehringer Ingelheim Investigational Site 86 Érd
Hungary Boehringer Ingelheim Investigational Site 78 Esztergom
Hungary Boehringer Ingelheim Investigational Site 60 Gyöngyös
Hungary Boehringer Ingelheim Investigational Site 52 Hajdúnánás
Hungary Boehringer Ingelheim Investigational Site 81 Kaposvár
Hungary Boehringer Ingelheim Investigational Site 54 Kecskemét
Hungary Boehringer Ingelheim Investigational Site 59 Kistokaj
Hungary Boehringer Ingelheim Investigational Site 71 Komárom
Hungary Boehringer Ingelheim Investigational Site 74 Komló
Hungary Boehringer Ingelheim Investigational Site 65 Mátraháza
Hungary Boehringer Ingelheim Investigational Site 72 Mosonmagyaróvár
Hungary Boehringer Ingelheim Investigational Site 83 Nyírbátor
Hungary Boehringer Ingelheim Investigational Site 53 Nyíregyháza
Hungary Boehringer Ingelheim Investigational Site 88 Nyíregyháza
Hungary Boehringer Ingelheim Investigational Site 73 Pécs
Hungary Boehringer Ingelheim Investigational Site 87 Szeged
Hungary Boehringer Ingelheim Investigational Site 84 Szentes
Hungary Boehringer Ingelheim Investigational Site 69 Szigetszentmiklós
Hungary Boehringer Ingelheim Investigational Site 82 Szombathely
Hungary Boehringer Ingelheim Investigational Site 76 Tapolca
Hungary Boehringer Ingelheim Investigational Site 79 Tatabánya
Hungary Boehringer Ingelheim Investigational Site 57 Tiszaújváros
Hungary Boehringer Ingelheim Investigational Site 70 Törökszentmiklós
Hungary Boehringer Ingelheim Investigational Site 75 Várpalota
Hungary Boehringer Ingelheim Investigational Site 80 Zalaegerszeg
Slovakia Boehringer Ingelheim Investigational Site 29 Banská Bystrica
Slovakia Boehringer Ingelheim Investigational Site 41 Bardejov
Slovakia Boehringer Ingelheim Investigational Site 42 Bardejov
Slovakia Boehringer Ingelheim Investigational Site 32 Bojnice
Slovakia Boehringer Ingelheim Investigational Site 1 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 9 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 45 Cadca
Slovakia Boehringer Ingelheim Investigational Site 28 Galanta
Slovakia Boehringer Ingelheim Investigational Site 17 Gelnica
Slovakia Boehringer Ingelheim Investigational Site 26 Hurbanovo
Slovakia Boehringer Ingelheim Investigational Site 12 Kosice
Slovakia Boehringer Ingelheim Investigational Site 13 Kosice
Slovakia Boehringer Ingelheim Investigational Site 14 Kosice
Slovakia Boehringer Ingelheim Investigational Site 15 Kosice
Slovakia Boehringer Ingelheim Investigational Site 16 Kosice
Slovakia Boehringer Ingelheim Investigational Site 25 Levice
Slovakia Boehringer Ingelheim Investigational Site 33 Lucenec
Slovakia Boehringer Ingelheim Investigational Site 35 Lucenec
Slovakia Boehringer Ingelheim Investigational Site 36 Lucenec
Slovakia Boehringer Ingelheim Investigational Site 44 Martin
Slovakia Boehringer Ingelheim Investigational Site 38 Michalovce
Slovakia Boehringer Ingelheim Investigational Site 4 Myjava
Slovakia Boehringer Ingelheim Investigational Site 22 Nitra
Slovakia Boehringer Ingelheim Investigational Site 23 Nitra
Slovakia Boehringer Ingelheim Investigational Site 24 Nitra
Slovakia Boehringer Ingelheim Investigational Site 30 Nová Bana
Slovakia Boehringer Ingelheim Investigational Site 48 Nové Mesto n. Váhom
Slovakia Boehringer Ingelheim Investigational Site 19 Nové Zámky
Slovakia Boehringer Ingelheim Investigational Site 20 Nové Zámky
Slovakia Boehringer Ingelheim Investigational Site 21 Nové Zámky
Slovakia Boehringer Ingelheim Investigational Site 5 Piestany
Slovakia Boehringer Ingelheim Investigational Site 47 Povazská Bystrica
Slovakia Boehringer Ingelheim Investigational Site 39 Presov
Slovakia Boehringer Ingelheim Investigational Site 40 Presov
Slovakia Boehringer Ingelheim Investigational Site 31 Prievidza
Slovakia Boehringer Ingelheim Investigational Site 11 Rimavská Sobota
Slovakia Boehringer Ingelheim Investigational Site 34 Rimavská Sobota
Slovakia Boehringer Ingelheim Investigational Site 10 Roznava
Slovakia Boehringer Ingelheim Investigational Site 2 Senec
Slovakia Boehringer Ingelheim Investigational Site 3 Senica
Slovakia Boehringer Ingelheim Investigational Site 18 Spisská Nová Ves
Slovakia Boehringer Ingelheim Investigational Site 37 Stropkov
Slovakia Boehringer Ingelheim Investigational Site 27 Topolcany
Slovakia Boehringer Ingelheim Investigational Site 6 Trnava
Slovakia Boehringer Ingelheim Investigational Site 7 Trnava
Slovakia Boehringer Ingelheim Investigational Site 8 Trnava
Slovakia Boehringer Ingelheim Investigational Site 46 Trstená
Slovakia Boehringer Ingelheim Investigational Site 43 Zilina
Slovenia Boehringer Ingelheim Investigational Site 49 Golnik
Slovenia Boehringer Ingelheim Investigational Site 50 Maribor-Pohorje

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Pfizer

Countries where clinical trial is conducted

Hungary,  Slovakia,  Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence. Baseline and 6 months No
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. The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence. 6 months and 12 months No
Secondary Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence. 12 months and baseline No
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