Pulmonary Disease, Chronic ObstructiveNCT00699699

Observational Non-Interventional Study With Spiriva Respimat in COPD Patients

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 188 sites in Germany.

Completed

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

Trial summary

This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients on treatment with Spiriva Respimat and allows adverse events to be recorded and evaluated. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
How many people: 1,280 participants
Where: 188 sitesGermany
Study dates: Jun 2008to Jan 2009
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: Patients

Who may be able to join

COPD patients who require treatment with longacting anticholinergic

Who cannot join

Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies. Spiriva® Respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.

Trial locations and contacts

188 sites in 1 country.

City, postcode or hospital

188 sites in 1 country

Germany188 sites

Boehringer Ingelheim Investigational Site
Aachen
Boehringer Ingelheim Investigational Site
Amberg
Boehringer Ingelheim Investigational Site
Auerbach
Boehringer Ingelheim Investigational Site 1
Augsburg
Boehringer Ingelheim Investigational Site 2
Augsburg
Boehringer Ingelheim Investigational Site 3
Augsburg
Boehringer Ingelheim Investigational Site
Backnang
Boehringer Ingelheim Investigational Site
Bad Doberan
Boehringer Ingelheim Investigational Site
Bad Kötzing
Boehringer Ingelheim Investigational Site
Bad Lippspringe
Boehringer Ingelheim Investigational Site
Bad Nauheim
Boehringer Ingelheim Investigational Site
Bad Reichenhall
Boehringer Ingelheim Investigational Site
Baden-Baden
Boehringer Ingelheim Investigational Site 1
Bergisch Gladbach
Boehringer Ingelheim Investigational Site 2
Bergisch Gladbach
Boehringer Ingelheim Investigational Site 1
Berlin
Boehringer Ingelheim Investigational Site 2
Berlin
Boehringer Ingelheim Investigational Site 3
Berlin
Boehringer Ingelheim Investigational Site 4
Berlin
Boehringer Ingelheim Investigational Site 5
Berlin
Boehringer Ingelheim Investigational Site 6
Berlin
Boehringer Ingelheim Investigational Site 7
Berlin
Boehringer Ingelheim Investigational Site 8
Berlin
Boehringer Ingelheim Investigational Site
Bochum
Boehringer Ingelheim Investigational Site 1
Bonn
Boehringer Ingelheim Investigational Site 2
Bonn
Boehringer Ingelheim Investigational Site
Bottrop
Boehringer Ingelheim Investigational Site 1
Braunschweig
Boehringer Ingelheim Investigational Site 2
Braunschweig
Boehringer Ingelheim Investigational Site 3
Braunschweig
Boehringer Ingelheim Investigational Site 1
Bremen
Boehringer Ingelheim Investigational Site 2
Bremen
Boehringer Ingelheim Investigational Site 1
Bremerhaven
Boehringer Ingelheim Investigational Site 2
Bremerhaven
Boehringer Ingelheim Investigational Site
Burg
Boehringer Ingelheim Investigational Site
Castrop-Rauxel
Boehringer Ingelheim Investigational Site
Celle
Boehringer Ingelheim Investigational Site
Cottbus
Boehringer Ingelheim Investigational Site
Detmold
Boehringer Ingelheim Investigational Site
Dillenburg
Boehringer Ingelheim Investigational Site
Donauwörth
Boehringer Ingelheim Investigational Site
Dormagen
Boehringer Ingelheim Investigational Site
Dorsten
Boehringer Ingelheim Investigational Site
Dortmund
Boehringer Ingelheim Investigational Site 1
Dresden
Boehringer Ingelheim Investigational Site 2
Dresden
Boehringer Ingelheim Investigational Site 3
Dresden
Boehringer Ingelheim Investigational Site
Duisburg
Boehringer Ingelheim Investigational Site
Düren
Boehringer Ingelheim Investigational Site 1
Düsseldorf
Boehringer Ingelheim Investigational Site 2
Düsseldorf
Boehringer Ingelheim Investigational Site 3
Düsseldorf
Boehringer Ingelheim Investigational Site 4
Düsseldorf
Boehringer Ingelheim Investigational Site 1
Emden
Boehringer Ingelheim Investigational Site 2
Emden
Boehringer Ingelheim Investigational Site
Erbach im Odenwald
Boehringer Ingelheim Investigational Site
Erfurt
Boehringer Ingelheim Investigational Site
Esslingen am Neckar
Boehringer Ingelheim Investigational Site
Euskirchen
Boehringer Ingelheim Investigational Site 2
Flensbrug
Boehringer Ingelheim Investigational Site 1
Flensburg
Boehringer Ingelheim Investigational Site
Frankenthal
Boehringer Ingelheim Investigational Site 1
Frankfurt
Boehringer Ingelheim Investigational Site 2
Frankfurt
Boehringer Ingelheim Investigational Site 3
Frankfurt
Boehringer Ingelheim Investigational Site 4
Frankfurt
Boehringer Ingelheim Investigational Site
Fürstenfeldbruck
Boehringer Ingelheim Investigational Site
Fürstenwalde
Boehringer Ingelheim Investigational Site
Fürth
Boehringer Ingelheim Investigational Site
Geilenkirchen
Boehringer Ingelheim Investigational Site 1
Giessen
Boehringer Ingelheim Investigational Site 2
Giessen
Boehringer Ingelheim Investigational Site
Grimma
Boehringer Ingelheim Investigational Site 1
Gütersloh
Boehringer Ingelheim Investigational Site 2
Gütersloh
Boehringer Ingelheim Investigational Site
Hainburg
Boehringer Ingelheim Investigational Site 1
Hamburg
Boehringer Ingelheim Investigational Site 2
Hamburg
Boehringer Ingelheim Investigational Site 3
Hamburg
Boehringer Ingelheim Investigational Site 4
Hamburg
Boehringer Ingelheim Investigational Site 5
Hamburg
Boehringer Ingelheim Investigational Site 6
Hamburg
Boehringer Ingelheim Investigational Site
Hamm
Boehringer Ingelheim Investigational Site 1
Hanover
Boehringer Ingelheim Investigational Site 2
Hanover
Boehringer Ingelheim Investigational Site 3
Hanover
Boehringer Ingelheim Investigational Site 1
Heidelberg
Boehringer Ingelheim Investigational Site 2
Heidelberg
Boehringer Ingelheim Investigational Site 1
Heilbronn
Boehringer Ingelheim Investigational Site 2
Heilbronn
Boehringer Ingelheim Investigational Site
Herne
Boehringer Ingelheim Investigational Site
Hildburghausen
Boehringer Ingelheim Investigational Site
Hilden
Boehringer Ingelheim Investigational Site
Hoyerswerda
Boehringer Ingelheim Investigational Site
Ibbenbueren
Boehringer Ingelheim Investigational Site
Karlsruhe
Boehringer Ingelheim Investigational Site 1
Kiel
Boehringer Ingelheim Investigational Site 2
Kiel
Boehringer Ingelheim Investigational Site 1
Koblenz
Boehringer Ingelheim Investigational Site 2
Koblenz
Boehringer Ingelheim Investigational Site
Königs Wusterhausen
Boehringer Ingelheim Investigational Site
Konstanz
Boehringer Ingelheim Investigational Site
Kyritz
Boehringer Ingelheim Investigational Site
Leipzig
Boehringer Ingelheim Investigational Site 1
Leverkusen
Boehringer Ingelheim Investigational Site 2
Leverkusen
Boehringer Ingelheim Investigational Site
Limbach-Oberfrohna
Boehringer Ingelheim Investigational Site
Lüdenscheid
Boehringer Ingelheim Investigational Site
Lüneburg
Boehringer Ingelheim Investigational Site 1
Magdeburg
Boehringer Ingelheim Investigational Site 2
Magdeburg
Boehringer Ingelheim Investigational Site 3
Magdeburg
Boehringer Ingelheim Investigational Site
Mannheim
Boehringer Ingelheim Investigational Site
Markkleeberg
Boehringer Ingelheim Investigational Site
Menden
Boehringer Ingelheim Investigational Site
Moers
Boehringer Ingelheim Investigational Site
Mönchengladbach
Boehringer Ingelheim Investigational Site
Mühlheim
Boehringer Ingelheim Investigational Site 1
München
Boehringer Ingelheim Investigational Site 2
München
Boehringer Ingelheim Investigational Site 3
München
Boehringer Ingelheim Investigational Site 4
München
Boehringer Ingelheim Investigational Site 5
München
Boehringer Ingelheim Investigational Site
Nauen
Boehringer Ingelheim Investigational Site
Norderstedt
Boehringer Ingelheim Investigational Site
Nordhausen
Boehringer Ingelheim Investigational Site
Nordhorn
Boehringer Ingelheim Investigational Site 1
Nuremberg
Boehringer Ingelheim Investigational Site 2
Nuremberg
Boehringer Ingelheim Investigational Site 3
Nuremberg
Boehringer Ingelheim Investigational Site 1
Oberhausen
Boehringer Ingelheim Investigational Site 2
Oberhausen
Boehringer Ingelheim Investigational Site
Oberursel
Boehringer Ingelheim Investigational Site 1
Offenbach
Boehringer Ingelheim Investigational Site 2
Offenbach
Boehringer Ingelheim Investigational Site
Offenburg
Boehringer Ingelheim Investigational Site
Olpe
Boehringer Ingelheim Investigational Site
Oranienburg
Boehringer Ingelheim Investigational Site
Osnabrück
Boehringer Ingelheim Investigational Site
Peine
Boehringer Ingelheim Investigational Site
Pforzheim
Boehringer Ingelheim Investigational Site
Rastatt
Boehringer Ingelheim Investigational Site 1
Ratingen
Boehringer Ingelheim Investigational Site 2
Ratingen
Boehringer Ingelheim Investigational Site
Recklinghausen
Boehringer Ingelheim Investigational Site
Remscheid
Boehringer Ingelheim Investigational Site
Rostock
Boehringer Ingelheim Investigational Site
Roth
Boehringer Ingelheim Investigational Site
Rottach-Egern
Boehringer Ingelheim Investigational Site
Rudolstadt
Boehringer Ingelheim Investigational Site
Rüsselsheim am Main
Boehringer Ingelheim Investigational Site 1
Saarbrücken
Boehringer Ingelheim Investigational Site 2
Saarbrücken
Boehringer Ingelheim Investigational Site 3
Saarbrücken
Boehringer Ingelheim Investigational Site
Saarlouis
Boehringer Ingelheim Investigational Site
Saint Ingbert
Boehringer Ingelheim Investigational Site
Salzgitter
Boehringer Ingelheim Investigational Site
Schleswig
Boehringer Ingelheim Investigational Site
Schmölln
Boehringer Ingelheim Investigational Site
Schwandorf in Bayern
Boehringer Ingelheim Investigational Site
Sebnitz
Boehringer Ingelheim Investigational Site
Siegen
Boehringer Ingelheim Investigational Site
Singen
Boehringer Ingelheim Investigational Site 1
Solingen
Boehringer Ingelheim Investigational Site 2
Solingen
Boehringer Ingelheim Investigational Site 3
Solingen
Boehringer Ingelheim Investigational Site 4
Solingen
Boehringer Ingelheim Investigational Site
Stadthagen
Boehringer Ingelheim Investigational Site
Steinhagen
Boehringer Ingelheim Investigational Site
Strausberg
Boehringer Ingelheim Investigational Site
Stremberg
Boehringer Ingelheim Investigational Site
Stuttgart
Boehringer Ingelheim Investigational Site
Tauberbischofsheim
Boehringer Ingelheim Investigational Site
Tübingen
Boehringer Ingelheim Investigational Site 1
Ulm
Boehringer Ingelheim Investigational Site 2
Ulm
Boehringer Ingelheim Investigational Site 3
Ulm
Boehringer Ingelheim Investigational Site
Velbert
Boehringer Ingelheim Investigational Site
Waren
Boehringer Ingelheim Investigational Site 1
Wiesbaden
Boehringer Ingelheim Investigational Site 2
Wiesbaden
Boehringer Ingelheim Investigational Site
Wiesloch
Boehringer Ingelheim Investigational Site 1
Wilhelmshaven
Boehringer Ingelheim Investigational Site 2
Wilhelmshaven
Boehringer Ingelheim Investigational Site
Witten
Boehringer Ingelheim Investigational Site
Wittstock
Boehringer Ingelheim Investigational Site
Wolfsburg
Boehringer Ingelheim Investigational Site
Zirndorf

Other trials in Germany

About this study

Official title: Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®

Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What is being measured

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

Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks
Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)
Measured: Baseline and after 6 weeks of treatment

Secondary outcomes (3)

Change From Baseline in the PF-10 Score After 6 Weeks
Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)
Measured: Baseline and after 6 weeks of treatment
Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety
Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications "poor" (1, 2), "satisfactory" (3, 4), "good" (5, 6), and "excellent" (7, 8))
Measured: Baseline and after 6 weeks of treatment
Patients' Satisfaction After 6 Weeks of Treatment
Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment ("very satisfied", "satisfied", "rather satisfied", "neither satisfied nor "unsatisfied", "rather unsatisfied", "unsatisfied", and "very unsatisfied")
Measured: 6 weeks

Timeline

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

Jun 2008Jan 2009

First posted18 Jun 2008 (estimated)
Study startJun 2008
Primary completionJan 2009

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
Time perspective: Prospective
Enrolment: 1,280 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00699699
Sponsor's protocol ID: 205.426
Status last verified: Mar 2014
First submitted: 17 Jun 2008
Last updated: 10 Apr 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

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®
ClinicalTrials.gov ID: NCT00699699
Acronym / sponsor ID: 205.426
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Study type: Observational
Recruitment status: Completed
Enrolment: 1,280 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Jan 2009 (actual)
First posted: 18 Jun 2008 (estimated)
Results: Posted 12 Mar 2010

Clinical summary

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

Study design

Time perspective: Prospective

Who may qualify

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

Key inclusion criteria (1 listed)

COPD patients who require treatment with longacting anticholinergic

Key exclusion criteria (1 listed)

Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies. Spiriva® Respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.

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

Primary outcome

Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks
Time frame: Baseline and after 6 weeks of treatment
Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)

3 secondary outcomes

Change From Baseline in the PF-10 Score After 6 Weeks
Time frame: Baseline and after 6 weeks of treatment
Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety
Time frame: Baseline and after 6 weeks of treatment
Patients' Satisfaction After 6 Weeks of Treatment
Time frame: 6 weeks

Results and safety

Results posted to the registry on 12 Mar 2010, 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® Respimat® 2 Puffs Once Daily at the Same Time	1,280	1,223

Primary outcome: Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks

Time frame: Baseline and after 6 weeks of treatment. Number. Unit: Percentage of participants

Measure	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time n = 1230
Value	61.5

Population analysed: There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spiriva® Respimat® 2 Puffs Once Daily at the Same Time	6 of 1,280 (0.5%)	0 of 1,280 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders

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

188 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 188 sites in Germany.

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 1 inclusion and 1 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 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in Germany. 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 12 Mar 2010). 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?

Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks (time frame: Baseline and after 6 weeks of treatment). 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 NCT00699699.

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 10 Apr 2014.