Pulmonary Disease, Chronic ObstructiveNCT01388166

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 90 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Education
Type of treatment: Surgery or procedure
How many people: 1,253 participants
Where: 90 sitesin 3 countries
Study dates: Sep 2011to Dec 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: COPD

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

90 sites in 3 countries.

Country

City, postcode or hospital

90 sites in 3 countries

Slovakia48 sites

Boehringer Ingelheim Investigational Site 29
Banská Bystrica
Boehringer Ingelheim Investigational Site 41
Bardejov
Boehringer Ingelheim Investigational Site 42
Bardejov
Boehringer Ingelheim Investigational Site 32
Bojnice
Boehringer Ingelheim Investigational Site 1
Bratislava
Boehringer Ingelheim Investigational Site 9
Bratislava
Boehringer Ingelheim Investigational Site 45
Čadca
Boehringer Ingelheim Investigational Site 28
Galanta
Boehringer Ingelheim Investigational Site 17
Gelnica
Boehringer Ingelheim Investigational Site 26
Hurbanovo
Boehringer Ingelheim Investigational Site 12
Košice
Boehringer Ingelheim Investigational Site 13
Košice
Boehringer Ingelheim Investigational Site 14
Košice
Boehringer Ingelheim Investigational Site 15
Košice
Boehringer Ingelheim Investigational Site 16
Košice
Boehringer Ingelheim Investigational Site 25
Levice
Boehringer Ingelheim Investigational Site 33
Lučenec
Boehringer Ingelheim Investigational Site 35
Lučenec
Boehringer Ingelheim Investigational Site 36
Lučenec
Boehringer Ingelheim Investigational Site 44
Martin
Boehringer Ingelheim Investigational Site 38
Michalovce
Boehringer Ingelheim Investigational Site 4
Myjava
Boehringer Ingelheim Investigational Site 22
Nitra
Boehringer Ingelheim Investigational Site 23
Nitra
Boehringer Ingelheim Investigational Site 24
Nitra
Boehringer Ingelheim Investigational Site 30
Nová Bana
Boehringer Ingelheim Investigational Site 48
Nové Mesto N. Váhom
Boehringer Ingelheim Investigational Site 19
Nové Zámky
Boehringer Ingelheim Investigational Site 20
Nové Zámky
Boehringer Ingelheim Investigational Site 21
Nové Zámky
Boehringer Ingelheim Investigational Site 5
Piešťany
Boehringer Ingelheim Investigational Site 47
Povazská Bystrica
Boehringer Ingelheim Investigational Site 39
Prešov
Boehringer Ingelheim Investigational Site 40
Prešov
Boehringer Ingelheim Investigational Site 31
Prievidza
Boehringer Ingelheim Investigational Site 11
Rimavská Sobota
Boehringer Ingelheim Investigational Site 34
Rimavská Sobota
Boehringer Ingelheim Investigational Site 10
Rožňava
Boehringer Ingelheim Investigational Site 2
Senec
Boehringer Ingelheim Investigational Site 3
Senica
Boehringer Ingelheim Investigational Site 18
Spisská Nová Ves
Boehringer Ingelheim Investigational Site 37
Stropkov
Boehringer Ingelheim Investigational Site 27
Topoľčany
Boehringer Ingelheim Investigational Site 6
Trnava
Boehringer Ingelheim Investigational Site 7
Trnava
Boehringer Ingelheim Investigational Site 8
Trnava
Boehringer Ingelheim Investigational Site 46
Trstená
Boehringer Ingelheim Investigational Site 43
Žilina

Other trials in Slovakia

Hungary40 sites

Boehringer Ingelheim Investigational Site 58
Baja
Boehringer Ingelheim Investigational Site 85
Békéscsaba
Boehringer Ingelheim Investigational Site 61
Budapest
Boehringer Ingelheim Investigational Site 62
Budapest
Boehringer Ingelheim Investigational Site 63
Budapest
Boehringer Ingelheim Investigational Site 66
Budapest
Boehringer Ingelheim Investigational Site 67
Budapest
Boehringer Ingelheim Investigational Site 68
Budapest
Boehringer Ingelheim Investigational Site 89
Budapest
Boehringer Ingelheim Investigational Site 90
Budapest
Boehringer Ingelheim Investigational Site 55
Cegléd
Boehringer Ingelheim Investigational Site 51
Debrecen
Boehringer Ingelheim Investigational Site 64
Dunakeszi
Boehringer Ingelheim Investigational Site 77
Dunaújváros
Boehringer Ingelheim Investigational Site 56
Edelény
Boehringer Ingelheim Investigational Site 86
Érd
Boehringer Ingelheim Investigational Site 78
Esztergom
Boehringer Ingelheim Investigational Site 60
Gyöngyös
Boehringer Ingelheim Investigational Site 52
Hajdúnánás
Boehringer Ingelheim Investigational Site 81
Kaposvár
Boehringer Ingelheim Investigational Site 54
Kecskemét
Boehringer Ingelheim Investigational Site 59
Kistokaj
Boehringer Ingelheim Investigational Site 71
Komárom
Boehringer Ingelheim Investigational Site 74
Komló
Boehringer Ingelheim Investigational Site 65
Mátraháza
Boehringer Ingelheim Investigational Site 72
Mosonmagyaróvár
Boehringer Ingelheim Investigational Site 83
Nyírbátor
Boehringer Ingelheim Investigational Site 53
Nyíregyháza
Boehringer Ingelheim Investigational Site 88
Nyíregyháza
Boehringer Ingelheim Investigational Site 73
Pécs
Boehringer Ingelheim Investigational Site 87
Szeged
Boehringer Ingelheim Investigational Site 84
Szentes
Boehringer Ingelheim Investigational Site 69
Szigetszentmiklós
Boehringer Ingelheim Investigational Site 82
Szombathely
Boehringer Ingelheim Investigational Site 76
Tapolca
Boehringer Ingelheim Investigational Site 79
Tatabánya
Boehringer Ingelheim Investigational Site 57
Tiszaújváros
Boehringer Ingelheim Investigational Site 70
Törökszentmiklós
Boehringer Ingelheim Investigational Site 75
Várpalota
Boehringer Ingelheim Investigational Site 80
Zalaegerszeg

Other trials in Hungary

Slovenia2 sites

Boehringer Ingelheim Investigational Site 49
Golnik
Boehringer Ingelheim Investigational Site 50
Maribor-Pohorje

Other trials in Slovenia

About this study

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

Read the detailed description

Purpose:

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Education
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EducationProcedure or surgery
Education

Study groups in NCT01388166
Study group	Role	What they receive
Patients with COPD		Not described Receives: Procedure: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 6 months

Secondary outcomes (2)

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.
Measured: 6 months and 12 months
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.
Measured: 12 months and baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Dec 2013

First posted6 Jul 2011 (estimated)
Study startSep 2011
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,253 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01388166
Sponsor's protocol ID: 205.483
Status last verified: Nov 2014
First submitted: 1 Jul 2011
Last updated: 4 Dec 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01388166
Acronym / sponsor ID: 205.483
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 1,253 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Sep 2011
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 6 Jul 2011 (estimated)
Results: Posted 4 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Purpose:

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with COPD	–	Procedure: Education

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: COPD

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EducationEducation	Procedure or surgery	Patients with COPD

Primary outcome

Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline
Time frame: Baseline and 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 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.

2 secondary outcomes

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.
Time frame: 6 months and 12 months
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline
Time frame: 12 months and baseline

Results and safety

Results posted to the registry on 4 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With COPD	1,253	1,194

Primary outcome: Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Patients With COPD n = 1168
Value	0.6 (1.84)

Patients With COPD: p <0.0001, t-test, 2 sided

Population analysed: This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With COPD	59 of 1,253 (4.7%)	0 of 1,253 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

90 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 90 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in Slovakia, Hungary, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01388166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.