Chronic Obstructive Pulmonary DiseaseNCT00540163

Observational Non-interventional Study With Spiriva in Chronic Obstructive Pulmonary Disease Patients With Exercise-induced Dyspnoea

An observational study of Chronic Obstructive Pulmonary Disease, run by Boehringer Ingelheim at 177 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 with exercise-induced dyspnoea on treatment with Spiriva (tiotropium 18 µg capsules) 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: Chronic Obstructive Pulmonary Disease
How many people: 1,296 participants
Where: 177 sitesGermany
Study dates: Apr 2007to Nov 2007
Phase: Observational
Are there results?: None posted in the registry

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 of office-based pulmonology practices

Who may be able to join

Men or women with COPD and a thoracic gas volume (TGV) of < 140% at rest, MRC value of 2 or more.

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.
Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.

Trial locations and contacts

177 sites in 1 country.

City, postcode or hospital

177 sites in 1 country

Germany177 sites

Boehringer Ingelheim Investigational Site
Amberg
Boehringer Ingelheim Investigational Site
Anklam
Boehringer Ingelheim Investigational Site
Aschau
Boehringer Ingelheim Investigational Site
Auerbach
Boehringer Ingelheim Investigational Site
Augsburg
Boehringer Ingelheim Investigational Site
Backnang
Boehringer Ingelheim Investigational Site
Bad Doberan
Boehringer Ingelheim Investigational Site
Bad Lippspringe
Boehringer Ingelheim Investigational Site
Bad Oeynhausen
Boehringer Ingelheim Investigational Site
Bad Soden
Boehringer Ingelheim Investigational Site
Bad Wörishofen
Boehringer Ingelheim Investigational Site
Beelitz
Boehringer Ingelheim Investigational Site
Bensheim
Boehringer Ingelheim Investigational Site
Bergisch Gladbach
Boehringer Ingelheim Investigational Site
Berlin
Boehringer Ingelheim Investigational Site
Biberach
Boehringer Ingelheim Investigational Site
Bochum
Boehringer Ingelheim Investigational Site
Bonn
Boehringer Ingelheim Investigational Site
Braunschweig
Boehringer Ingelheim Investigational Site
Breisach
Boehringer Ingelheim Investigational Site
Bremen
Boehringer Ingelheim Investigational Site
Bremerhaven
Boehringer Ingelheim Investigational Site
Bruchsal
Boehringer Ingelheim Investigational Site
Buchholz
Boehringer Ingelheim Investigational Site
Bünde
Boehringer Ingelheim Investigational Site
Calw
Boehringer Ingelheim Investigational Site
Castrop-Rauxel
Boehringer Ingelheim Investigational Site
Celle
Boehringer Ingelheim Investigational Site
Chemnitz
Boehringer Ingelheim Investigational Site
Coburg
Boehringer Ingelheim Investigational Site
Cologne
Boehringer Ingelheim Investigational Site
Cottbus
Boehringer Ingelheim Investigational Site
Darmstadt
Boehringer Ingelheim Investigational Site
Dillenburg
Boehringer Ingelheim Investigational Site
Dinslaken
Boehringer Ingelheim Investigational Site
Dortmund
Boehringer Ingelheim Investigational Site
Dresden
Boehringer Ingelheim Investigational Site
Duisburg
Boehringer Ingelheim Investigational Site
Düren
Boehringer Ingelheim Investigational Site
Düsseldorf
Boehringer Ingelheim Investigational Site
Eisenhüttenstadt
Boehringer Ingelheim Investigational Site
Emden
Boehringer Ingelheim Investigational Site
Erbach im Odenwald
Boehringer Ingelheim Investigational Site
Erfurt
Boehringer Ingelheim Investigational Site
Essen
Boehringer Ingelheim Investigational Site
Esslingen am Neckar
Boehringer Ingelheim Investigational Site
Euskirchen
Boehringer Ingelheim Investigational Site
Fellbach
Boehringer Ingelheim Investigational Site
Flensburg
Boehringer Ingelheim Investigational Site
Forchheim
Boehringer Ingelheim Investigational Site
Frankfurt
Boehringer Ingelheim Investigational Site
Freising
Boehringer Ingelheim Investigational Site
Fürstenfeldbruck
Boehringer Ingelheim Investigational Site
Fürth
Boehringer Ingelheim Investigational Site
Gadebusch
Boehringer Ingelheim Investigational Site
Geilenkirchen
Boehringer Ingelheim Investigational Site
Gelnhausen
Boehringer Ingelheim Investigational Site
Gelsenkirchen
Boehringer Ingelheim Investigational Site
Germering
Boehringer Ingelheim Investigational Site
Giessen
Boehringer Ingelheim Investigational Site
Gifhorn
Boehringer Ingelheim Investigational Site
Göppingen
Boehringer Ingelheim Investigational Site
Gotha
Boehringer Ingelheim Investigational Site
Greiz
Boehringer Ingelheim Investigational Site
Gummersbach
Boehringer Ingelheim Investigational Site
Gütersloh
Boehringer Ingelheim Investigational Site
Halberstadt
Boehringer Ingelheim Investigational Site
Halle
Boehringer Ingelheim Investigational Site
Hamburg
Boehringer Ingelheim Investigational Site
Hamelin
Boehringer Ingelheim Investigational Site
Hamm
Boehringer Ingelheim Investigational Site
Hanover
Boehringer Ingelheim Investigational Site
Heidelberg
Boehringer Ingelheim Investigational Site
Heilbronn
Boehringer Ingelheim Investigational Site
Herne
Boehringer Ingelheim Investigational Site
Hilden
Boehringer Ingelheim Investigational Site
Hildesheim
Boehringer Ingelheim Investigational Site
Hoyerswerda
Boehringer Ingelheim Investigational Site
Ibbenbueren
Boehringer Ingelheim Investigational Site
Ingolstadt
Boehringer Ingelheim Investigational Site
Iserlohn
Boehringer Ingelheim Investigational Site
Kaiserslautern
Boehringer Ingelheim Investigational Site
Kamen
Boehringer Ingelheim Investigational Site
Karlsruhe
Boehringer Ingelheim Investigational Site
Kaufbeuren
Boehringer Ingelheim Investigational Site
Kempten
Boehringer Ingelheim Investigational Site
Kevelaer
Boehringer Ingelheim Investigational Site
Kiel
Boehringer Ingelheim Investigational Site
Konstanz
Boehringer Ingelheim Investigational Site
Krefeld
Boehringer Ingelheim Investigational Site
Landshut
Boehringer Ingelheim Investigational Site
Langenfeld
Boehringer Ingelheim Investigational Site
Leipzig
Boehringer Ingelheim Investigational Site
Limburg
Boehringer Ingelheim Investigational Site
Lindenberg
Boehringer Ingelheim Investigational Site
Linz
Boehringer Ingelheim Investigational Site
Lippstadt
Boehringer Ingelheim Investigational Site
Loerrach
Boehringer Ingelheim Investigational Site
Lüdenscheid
Boehringer Ingelheim Investigational Site
Ludwigsburg
Boehringer Ingelheim Investigational Site
Lüneburg
Boehringer Ingelheim Investigational Site
Magdeburg
Boehringer Ingelheim Investigational Site
Mainz
Boehringer Ingelheim Investigational Site
Marburg
Boehringer Ingelheim Investigational Site
Markkleeberg
Boehringer Ingelheim Investigational Site
Memmingen
Boehringer Ingelheim Investigational Site
Menden
Boehringer Ingelheim Investigational Site
Minden
Boehringer Ingelheim Investigational Site
Moers
Boehringer Ingelheim Investigational Site
Mönchengladbach
Boehringer Ingelheim Investigational Site
Mühldorf
Boehringer Ingelheim Investigational Site
Mülheim
Boehringer Ingelheim Investigational Site
München
Boehringer Ingelheim Investigational Site
Neu-Ulm
Boehringer Ingelheim Investigational Site
Neunkirchen
Boehringer Ingelheim Investigational Site
Norderstedt
Boehringer Ingelheim Investigational Site
Nordhausen
Boehringer Ingelheim Investigational Site
Nuremberg
Boehringer Ingelheim Investigational Site
Oberursel
Boehringer Ingelheim Investigational Site
Olpe
Boehringer Ingelheim Investigational Site
Oschersleben
Boehringer Ingelheim Investigational Site
Osnabrück
Boehringer Ingelheim Investigational Site
Papenburg
Boehringer Ingelheim Investigational Site
Peine
Boehringer Ingelheim Investigational Site
Plauen
Boehringer Ingelheim Investigational Site
Potsdam
Boehringer Ingelheim Investigational Site
Pulheim
Boehringer Ingelheim Investigational Site
Rastatt
Boehringer Ingelheim Investigational Site
Rathenow
Boehringer Ingelheim Investigational Site
Regensburg
Boehringer Ingelheim Investigational Site
Remscheid
Boehringer Ingelheim Investigational Site
Rendsburg
Boehringer Ingelheim Investigational Site
Rostock
Boehringer Ingelheim Investigational Site
Rüdersdorf
Boehringer Ingelheim Investigational Site
Rüsselsheim am Main
Boehringer Ingelheim Investigational Site
Saarbrücken
Boehringer Ingelheim Investigational Site
Saarlouis
Boehringer Ingelheim Investigational Site
Salzgitter
Boehringer Ingelheim Investigational Site
Schenefeld
Boehringer Ingelheim Investigational Site
Schleswig
Boehringer Ingelheim Investigational Site
Schmölln
Boehringer Ingelheim Investigational Site
Schwalmstadt
Boehringer Ingelheim Investigational Site
Schwalmtal
Boehringer Ingelheim Investigational Site
Schwerin
Boehringer Ingelheim Investigational Site
Sebnitz
Boehringer Ingelheim Investigational Site
Seevetal
Boehringer Ingelheim Investigational Site
Siegen
Boehringer Ingelheim Investigational Site
Singen
Boehringer Ingelheim Investigational Site
Sinsheim
Boehringer Ingelheim Investigational Site
Solingen
Boehringer Ingelheim Investigational Site
Sonneberg
Boehringer Ingelheim Investigational Site
Spremberg
Boehringer Ingelheim Investigational Site
Stade
Boehringer Ingelheim Investigational Site
Starnberg
Boehringer Ingelheim Investigational Site
Steinbach
Boehringer Ingelheim Investigational Site
Straelen
Boehringer Ingelheim Investigational Site
Strausberg
Boehringer Ingelheim Investigational Site
Stuttgart
Boehringer Ingelheim Investigational Site
Teltow
Boehringer Ingelheim Investigational Site
Teterow
Boehringer Ingelheim Investigational Site
Troisdorf
Boehringer Ingelheim Investigational Site
Unna
Boehringer Ingelheim Investigational Site
Uttenreuth
Boehringer Ingelheim Investigational Site
Verden an der Aller
Boehringer Ingelheim Investigational Site
Waiblingen
Boehringer Ingelheim Investigational Site
Waren
Boehringer Ingelheim Investigational Site
Warendorf
Boehringer Ingelheim Investigational Site
Weiden
Boehringer Ingelheim Investigational Site
Weißenhorn
Boehringer Ingelheim Investigational Site
Wetzlar
Boehringer Ingelheim Investigational Site
Wiesloch
Boehringer Ingelheim Investigational Site
Wilhelmshaven
Boehringer Ingelheim Investigational Site
Witten
Boehringer Ingelheim Investigational Site
Worms
Boehringer Ingelheim Investigational Site
Wuppertal
Boehringer Ingelheim Investigational Site
Zella-Mehlis
Boehringer Ingelheim Investigational Site
Zossen

Other trials in Germany

About this study

Official title: Improvement in Physical Functioning (SF-36 Activity Score) in COPD Patients With Exercise-induced Dyspnoea on Treatment With Spiriva® 18 Microgram (Capsules Containing 18 μg Tiotropium).

Read the detailed description

Study Design:

Conditions: Chronic Obstructive Pulmonary Disease
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What is being measured

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

The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram
Measured: 6 weeks

Secondary outcomes (1)

The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram
Measured: 6 weeks

Timeline

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

Apr 2007Nov 2007

First posted5 Oct 2007 (estimated)
Study startApr 2007
Primary completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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: 1,296 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00540163
Sponsor's protocol ID: 205.402
Status last verified: Oct 2013
First submitted: 21 Sep 2007
Last updated: 28 Nov 2013
Results posted: No

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

RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improvement in Physical Functioning (SF-36 Activity Score) in COPD Patients With Exercise-induced Dyspnoea on Treatment With Spiriva® 18 Microgram (Capsules Containing 18 μg Tiotropium).
ClinicalTrials.gov ID: NCT00540163
Acronym / sponsor ID: 205.402
Conditions: Chronic Obstructive Pulmonary Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 1,296 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Nov 2007 (actual)
First posted: 5 Oct 2007 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study Design:

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 of office-based pulmonology practices

Key inclusion criteria (1 listed)

Men or women with COPD and a thoracic gas volume (TGV) of < 140% at rest, MRC value of 2 or more.

Key exclusion criteria (2 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.
Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.

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

The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram
Time frame: 6 weeks

1 secondary outcome

The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram
Time frame: 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
Related InfoLink provided by the sponsor.

Related trials for Chronic Obstructive Pulmonary Disease

RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)

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

177 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by Boehringer Ingelheim at 177 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 2 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 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram (time frame: 6 weeks). 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 NCT00540163.

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 28 Nov 2013.