Clinical trial NCT01388166: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2011-07-06
Enrollment: 1253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD

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:

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.

Primary outcomes:
measure: Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months and 12 months
measure: Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline
timeFrame: 12 months and baseline
Other outcomes:
Locations:
city: Baja
country: Hungary
facility: Boehringer Ingelheim Investigational Site 58
city: Budapest
country: Hungary
facility: Boehringer Ingelheim Investigational Site 61
city: Budapest
country: Hungary
facility: Boehringer Ingelheim Investigational Site 62
city: Budapest
country: Hungary
facility: Boehringer Ingelheim Investigational Site 63
city: Budapest
country: Hungary
facility: Boehringer Ingelheim Investigational Site 66
city: Budapest
country: Hungary
facility: Boehringer Ingelheim Investigational Site 67
city: Budapest
country: Hungary
facility: Boehringer Ingelheim Investigational Site 68
city: Budapest
country: Hungary
facility: Boehringer Ingelheim Investigational Site 89
city: Budapest
country: Hungary
facility: Boehringer Ingelheim Investigational Site 90
city: Békéscsaba
country: Hungary
facility: Boehringer Ingelheim Investigational Site 85
city: Cegléd
country: Hungary
facility: Boehringer Ingelheim Investigational Site 55
city: Debrecen
country: Hungary
facility: Boehringer Ingelheim Investigational Site 51
city: Dunakeszi
country: Hungary
facility: Boehringer Ingelheim Investigational Site 64
city: Dunaújváros
country: Hungary
facility: Boehringer Ingelheim Investigational Site 77
city: Edelény
country: Hungary
facility: Boehringer Ingelheim Investigational Site 56
city: Esztergom
country: Hungary
facility: Boehringer Ingelheim Investigational Site 78
city: Gyöngyös
country: Hungary
facility: Boehringer Ingelheim Investigational Site 60
city: Hajdúnánás
country: Hungary
facility: Boehringer Ingelheim Investigational Site 52
city: Kaposvár
country: Hungary
facility: Boehringer Ingelheim Investigational Site 81
city: Kecskemét
country: Hungary
facility: Boehringer Ingelheim Investigational Site 54
city: Kistokaj
country: Hungary
facility: Boehringer Ingelheim Investigational Site 59
city: Komló
country: Hungary
facility: Boehringer Ingelheim Investigational Site 74
city: Komárom
country: Hungary
facility: Boehringer Ingelheim Investigational Site 71
city: Mosonmagyaróvár
country: Hungary
facility: Boehringer Ingelheim Investigational Site 72
city: Mátraháza
country: Hungary
facility: Boehringer Ingelheim Investigational Site 65
city: Nyírbátor
country: Hungary
facility: Boehringer Ingelheim Investigational Site 83
city: Nyíregyháza
country: Hungary
facility: Boehringer Ingelheim Investigational Site 53
city: Nyíregyháza
country: Hungary
facility: Boehringer Ingelheim Investigational Site 88
city: Pécs
country: Hungary
facility: Boehringer Ingelheim Investigational Site 73
city: Szeged
country: Hungary
facility: Boehringer Ingelheim Investigational Site 87
city: Szentes
country: Hungary
facility: Boehringer Ingelheim Investigational Site 84
city: Szigetszentmiklós
country: Hungary
facility: Boehringer Ingelheim Investigational Site 69
city: Szombathely
country: Hungary
facility: Boehringer Ingelheim Investigational Site 82
city: Tapolca
country: Hungary
facility: Boehringer Ingelheim Investigational Site 76
city: Tatabánya
country: Hungary
facility: Boehringer Ingelheim Investigational Site 79
city: Tiszaújváros
country: Hungary
facility: Boehringer Ingelheim Investigational Site 57
city: Törökszentmiklós
country: Hungary
facility: Boehringer Ingelheim Investigational Site 70
city: Várpalota
country: Hungary
facility: Boehringer Ingelheim Investigational Site 75
city: Zalaegerszeg
country: Hungary
facility: Boehringer Ingelheim Investigational Site 80
city: Érd
country: Hungary
facility: Boehringer Ingelheim Investigational Site 86
city: Banská Bystrica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 29
city: Bardejov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 41
city: Bardejov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 42
city: Bojnice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 32
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 1
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 9
city: Cadca
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 45
city: Galanta
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 28
city: Gelnica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 17
city: Hurbanovo
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 26
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 12
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 13
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 14
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 15
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 16
city: Levice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 25
city: Lucenec
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 33
city: Lucenec
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 35
city: Lucenec
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 36
city: Martin
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 44
city: Michalovce
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 38
city: Myjava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 4
city: Nitra
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 22
city: Nitra
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 23
city: Nitra
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 24
city: Nová Bana
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 30
city: Nové Mesto n. Váhom
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 48
city: Nové Zámky
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 19
city: Nové Zámky
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 20
city: Nové Zámky
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 21
city: Piestany
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 5
city: Povazská Bystrica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 47
city: Presov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 39
city: Presov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 40
city: Prievidza
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 31
city: Rimavská Sobota
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 11
city: Rimavská Sobota
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 34
city: Roznava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 10
city: Senec
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 2
city: Senica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 3
city: Spisská Nová Ves
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 18
city: Stropkov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 37
city: Topolcany
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 27
city: Trnava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 6
city: Trnava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 7
city: Trnava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 8
city: Trstená
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 46
city: Zilina
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 43
city: Golnik
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 49
city: Maribor-Pohorje
country: Slovenia
facility: Boehringer Ingelheim Investigational Site 50
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: