Pulmonary Disease, Chronic ObstructivePhase 3NCT00239473

12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

A Phase 3 study testing 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler and 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 38 sites in 4 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler and 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
Type of treatment: Medical device
How many people: 429 participants
Where: 38 sitesin 4 countries
Study dates: Nov 2002to Dec 2003
Phase: Phase 3
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)

Trial locations and contacts

38 sites in 4 countries.

Country

City, postcode or hospital

38 sites in 4 countries

Germany17 sites

Boehringer Ingelheim Investigational Site
Berlin
MEDARS GmbH
Berlin
Boehringer Ingelheim Investigational Site
Bonn
Boehringer Ingelheim Investigational Site
Frankfurt am Main
Inamed Research GmbH & Co. KG
Gauting
Pneumologisches Forschungsinstitut GmbH
Großhansdorf
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
Hamburg
Boehringer Ingelheim Investigational Site
Hanover
Universitätsklinikum Schleswig-Holstein
Kiel
ClinPharm International GmbH & Co. KG
Leipzig
Neurologische Klinik der Otto-von-Guericke-Universität
Magdeburg
Johannes-Gutenberg-Universität Mainz
Mainz
Boehringer Ingelheim Investigational Site
Minden
Medizinische Klinik III
Moers
Boehringer Ingelheim Investigational Site
München
Abt. Lungen- und Bronchialheilkunde
Schmallenberg
Boehringer Ingelheim Investigational Site
Steinfurt

Other trials in Germany

Italy9 sites

Ospedale Generale Provinciale Mazzoni
Ascoli Piceno
Dip. di Medicina Interna e Medicina Specialistica
Catania
U. O. di Fisiopatologia Respiratoria
Ferrara
Ospedale S. Martino
Genova
U. O. di Pneumologia e Servizio di Fisiopatologia Resp.
Milan
IRCCS Policlinico San Matteo
Pavia
U. O. C di Pneumologia
Roma
Ospedale Silvestrini
San Sisto (pg)
U. O. di Pneumologia
Trieste

Other trials in Italy

Switzerland8 sites

Universitätskliniken Basel
Basel
Ospedale San Giovanni
Bellinzona
Boehringer Ingelheim Investigational Site
Davos
Boehringer Ingelheim Investigational Site
Laufen
Boehringer Ingelheim Investigational Site
Locarno
Ospedale Regionale
Lugano
Boehringer Ingelheim Investigational Site
Münchenstein
Kantonsspital St. Gallen
Sankt Gallen

Other trials in Switzerland

South Africa4 sites

Hydromed Hospital
Bloemfontein
UCT Lung Institute
Cape Town
1 Military Hospital
Pretoria
Tygerberg Hospital
Tygerberg

Other trials in South Africa

About this study

Official title: A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler, 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
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.

5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhalerDevice
10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhalerDevice

What is being measured

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

Trough FEV1 response
Measured: after 12 weeks

Secondary outcomes (12)

Trough FEV1 response
Measured: after 1, 4 and 8 weeks
Trough FVC response
Measured: after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve (AUC)0-6h and peak response
Measured: after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements
Measured: during 12 weeks
Onset and duration of therapeutic response and percentage of responders
Measured: after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)
Measured: up to 12 weeks
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)
Measured: up to 12 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Measured: up to 15 weeks
Physician's Global Evaluation
Measured: up to 15 weeks
Number of patients with at least one exacerbation of COPD
Measured: up to 15 weeks
Time to first exacerbation
Measured: up to 15 weeks
Number of exacerbations and exacerbation days
Measured: up to 15 weeks

Timeline

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

Nov 2002Dec 2003

First posted17 Oct 2005 (estimated)
Study startNov 2002
Primary completionDec 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 429 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00239473
Sponsor's protocol ID: 205.251
Status last verified: Oct 2013
First submitted: 14 Oct 2005
Last updated: 1 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

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 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT00239473
Acronym / sponsor ID: 205.251
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 429 participants
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2002
Primary completion: Dec 2003 (actual)
First posted: 17 Oct 2005 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

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

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
5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler	Device	–
10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler	Device	–

Primary outcome

Trough FEV1 response
Time frame: after 12 weeks

12 secondary outcomes

Trough FEV1 response
Time frame: after 1, 4 and 8 weeks
Trough FVC response
Time frame: after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve (AUC)0-6h and peak response
Time frame: after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements
Time frame: during 12 weeks
Onset and duration of therapeutic response and percentage of responders
Time frame: after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)
Time frame: up to 12 weeks
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)
Time frame: up to 12 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time frame: up to 15 weeks
Physician's Global Evaluation
Time frame: up to 15 weeks
Number of patients with at least one exacerbation of COPD
Time frame: up to 15 weeks
Time to first exacerbation
Time frame: up to 15 weeks
Number of exacerbations and exacerbation days
Time frame: up to 15 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 1 Nov 2013.
Related InfoLink provided by the sponsor.
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 Coordinator study chair

Boehringer Ingelheim

38 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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

Who may be eligible to take part?

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 1 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 38 sites in Germany, Italy, Switzerland, South Africa. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Trough FEV1 response (time frame: after 12 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 NCT00239473.

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 1 Nov 2013.