Pulmonary Disease, Chronic ObstructiveNCT00615992

Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 73 sites in Austria.

Completed

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

Trial summary

The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium
How many people: 754 participants
Where: 73 sitesAustria
Study dates: Apr 2007to Apr 2008
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: primary care

Who may be able to join

Patients with suspected chronic obstructive pulmonary disease (COPD)
3 or more positive answers in COPD questionnaire
Age over 40 years

Who cannot join

Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
Patient treated with Spiriva in the past year
Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics

Trial locations and contacts

73 sites in 1 country.

City, postcode or hospital

73 sites in 1 country

Austria73 sites

Boehringer Ingelheim Investigational Site
Admont
Boehringer Ingelheim Investigational Site
Afritz Am See
Boehringer Ingelheim Investigational Site
Altenmarkt
Boehringer Ingelheim Investigational Site
Altmünster
Boehringer Ingelheim Investigational Site
Bad Gleichenberg
Boehringer Ingelheim Investigational Site
Bad Goisern am Hallstättersee
Boehringer Ingelheim Investigational Site
Bad Hall
Boehringer Ingelheim Investigational Site
Bad Häring
Boehringer Ingelheim Investigational Site
Bleiburg
Boehringer Ingelheim Investigational Site
Bludenz
Boehringer Ingelheim Investigational Site
Brixlegg
Boehringer Ingelheim Investigational Site
Drasenhofen
Boehringer Ingelheim Investigational Site
Enns
Boehringer Ingelheim Investigational Site
Fohnsdorf
Boehringer Ingelheim Investigational Site
Gänserndorf
Boehringer Ingelheim Investigational Site
Gmunden
Boehringer Ingelheim Investigational Site
Grafenstein
Boehringer Ingelheim Investigational Site
Graz
Boehringer Ingelheim Investigational Site
Grünbach
Boehringer Ingelheim Investigational Site
Gunskirchen
Boehringer Ingelheim Investigational Site
Gutenstein
Boehringer Ingelheim Investigational Site
Haid
Boehringer Ingelheim Investigational Site
Hainburg/a.d. Donau
Boehringer Ingelheim Investigational Site
Herzogenburg
Boehringer Ingelheim Investigational Site
Hürm
Boehringer Ingelheim Investigational Site
Innsbruck
Boehringer Ingelheim Investigational Site
Jenbach
Boehringer Ingelheim Investigational Site
Judenburg
Boehringer Ingelheim Investigational Site
Kindberg
Boehringer Ingelheim Investigational Site
Kirchberg Wechsel
Boehringer Ingelheim Investigational Site
Klagenfurt
Boehringer Ingelheim Investigational Site
Klein-Pöchlarn
Boehringer Ingelheim Investigational Site
Knittelfeld
Boehringer Ingelheim Investigational Site
Königswiesen
Boehringer Ingelheim Investigational Site
Kuchl
Boehringer Ingelheim Investigational Site
Langenrohr
Boehringer Ingelheim Investigational Site
Lebring
Boehringer Ingelheim Investigational Site
Leobersdorf
Boehringer Ingelheim Investigational Site
Linz
Boehringer Ingelheim Investigational Site
Lustenau
Boehringer Ingelheim Investigational Site
Mank
Boehringer Ingelheim Investigational Site
Mödling
Boehringer Ingelheim Investigational Site
Neuberg/Mürz
Boehringer Ingelheim Investigational Site
Neumarkt a.W.
Boehringer Ingelheim Investigational Site
Neunkirchen
Boehringer Ingelheim Investigational Site
Niederhollabrunn
Boehringer Ingelheim Investigational Site
Oberschützen
Boehringer Ingelheim Investigational Site
Ollersdorf
Boehringer Ingelheim Investigational Site
Passail
Boehringer Ingelheim Investigational Site
Peesen
Boehringer Ingelheim Investigational Site
Pfarrkirchen bei Bad Hall
Boehringer Ingelheim Investigational Site
Pichl bei Wels
Boehringer Ingelheim Investigational Site
Pischeldorf
Boehringer Ingelheim Investigational Site
Rattenberg
Boehringer Ingelheim Investigational Site
Saint Johann
Boehringer Ingelheim Investigational Site
Saint Stefan O Stainz
Boehringer Ingelheim Investigational Site
Saint Veit Glan
Boehringer Ingelheim Investigational Site
Salzburg
Boehringer Ingelheim Investigational Site
Sankt Valentin
Boehringer Ingelheim Investigational Site
Schwechat
Boehringer Ingelheim Investigational Site
St.Georgen/Judenburg 12
Boehringer Ingelheim Investigational Site
Stainach
Boehringer Ingelheim Investigational Site
Stasshof
Boehringer Ingelheim Investigational Site
Traismauer
Boehringer Ingelheim Investigational Site
Tulln
Boehringer Ingelheim Investigational Site
Vienna
Boehringer Ingelheim Investigational Site
Vöcklabruck
Boehringer Ingelheim Investigational Site
Wallern an der Trattnach
Boehringer Ingelheim Investigational Site
Weißtrach
Boehringer Ingelheim Investigational Site
Weiz
Boehringer Ingelheim Investigational Site
Wilhelmsburg
Boehringer Ingelheim Investigational Site
Wolfsberg
Boehringer Ingelheim Investigational Site
Wolkersdorf

Other trials in Austria

About this study

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium
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.

TiotropiumDrug

What is being measured

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

Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Measured: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Secondary outcomes (5)

Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Measured: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Efficacy by Patient
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Measured: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Tolerability by Patient
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Measured: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Efficacy by Physician
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Measured: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Tolerability by Physician
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Measured: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Timeline

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

Apr 2007Apr 2008

First posted14 Feb 2008 (estimated)
Study startApr 2007
Primary completionApr 2008

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
Enrolment: 754 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00615992
Sponsor's protocol ID: 205.398
Status last verified: Jan 2016
First submitted: 24 Jan 2008
Last updated: 8 Feb 2016
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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
ClinicalTrials.gov ID: NCT00615992
Acronym / sponsor ID: 205.398
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 754 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Apr 2008 (actual)
First posted: 14 Feb 2008 (estimated)
Results: Posted 24 Dec 2009

Clinical summary

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

Study design

Observational model: Cohort

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: primary care

Key inclusion criteria (3 listed)

Patients with suspected chronic obstructive pulmonary disease (COPD)
3 or more positive answers in COPD questionnaire
Age over 40 years

Key exclusion criteria (3 listed)

Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
Patient treated with Spiriva in the past year
Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics

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
Tiotropium	Drug	–

Primary outcome

Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva
Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)

5 secondary outcomes

Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva
Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Efficacy by Patient
Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Tolerability by Patient
Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Efficacy by Physician
Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Global Assessment of Tolerability by Physician
Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Results and safety

Results posted to the registry on 24 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spiriva® (Tiotropium Bromide)	754	687

Primary outcome: Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva

Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days). Mean (Standard Deviation). Unit: points on a scale

Measure	Spiriva® (Tiotropium Bromide) n = 687
Value	1.1 (0.7)

Population analysed: The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spiriva® (Tiotropium Bromide)	0 of 754 (0%)	0 of 754 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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

73 sites in 1 country: 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 73 sites in Austria.

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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Austria. 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 24 Dec 2009). 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?

Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva (time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)). 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 NCT00615992.

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 8 Feb 2016.