Pulmonary Disease, Chronic ObstructivePhase 4NCT00388882

Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.

A Phase 4 study testing tiotropium and ipratropium bromide / albuterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 40 sites in 5 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 study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI. 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 and ipratropium bromide / albuterol
How many people: 327 participants
Where: 40 sitesin 5 countries
Study dates: 4 Oct 2006to 8 Oct 2007
Phase: Phase 4
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

Who may be able to join

Diagnosis of COPD
Age: >= 40 years
Current or ex-smoker with a >= 10 pack-year smoking history
Use of Combivent® MDI for >= 1 month prior to Visit 1 Spirometric criteria (determined at study visits):
Post-bronchodilator FEV1 <= 70% (Visit 1)
Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/FVC <= 70% (Visit 2)

Who cannot join

Clinical history of asthma
History of thoracotomy with pulmonary resection
History of CF, alpha 1 antitrypsin deficiency or interstitial lung disease
Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain from using oxygen during PFTs
Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
Recent history 6 months or less of MI

Show all 15Show fewer

Unstable or life-threatening cardiac arrhythmias
Hospitalization for CHF during past year
Malignancy for which patient is receiving chemo or radiation therapy
Pregnant or nursing women
Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose
Use of SPIRIVA® 3 months prior to Visit 1
Symptomatic of prostatic hypertrophy or bladder neck obstruction
Known narrow- angle glaucoma
Participating in a pulmonary rehab program within 4 weeks of Visit 1

Trial locations and contacts

40 sites in 5 countries.

Country

City, postcode or hospital

40 sites in 5 countries

United States10 sites

205.346.105 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.346.102 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho
205.346.104 Boehringer Ingelheim Investigational Site
Lakewood, California
205.346.110 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
205.346.107 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
205.346.108 Boehringer Ingelheim Investigational Site
Sepulveda, California
205.346.109 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
205.346.103 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
205.346.101 Boehringer Ingelheim Investigational Site
Torrance, California
205.346.106 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado

Other trials in United States

Lithuania9 sites

205.346.401 Boehringer Ingelheim Investigational Site
Alytus
205.346.404 Boehringer Ingelheim Investigational Site
Kaunas
205.346.405 Boehringer Ingelheim Investigational Site
Kaunas
205.346.411 Boehringer Ingelheim Investigational Site
Klaipėda
205.346.409 Boehringer Ingelheim Investigational Site
Šiauliai
205.346.408 Boehringer Ingelheim Investigational Site
Utena
205.346.402 Boehringer Ingelheim Investigational Site
Vilnius
205.346.406 Boehringer Ingelheim Investigational Site
Vilnius
205.346.407 Boehringer Ingelheim Investigational Site
Vilnius

Other trials in Lithuania

Argentina8 sites

205.346.510
Bs As
205.346.502
Buenos Aires
205.346.503
Buenos Aires
205.346.508
Buenos Airess
205.346.505
Mendoza
205.346.509
Rosario, Santa Fe
205.346.511
Rosario, Santa Fé
205.346.504 Instituto de Patologías Respiratorias
San Miguel de Tucumán

Other trials in Argentina

United Kingdom7 sites

205.346.204 Boehringer Ingelheim Investigational Site
Aylesbury
205.346.203 Boehringer Ingelheim Investigational Site
Greenisland
205.346.201 Boehringer Ingelheim Investigational Site
Nottingham
205.346.207 Boehringer Ingelheim Investigational Site
Soham
205.346.209 Boehringer Ingelheim Investigational Site
Swansea
205.346.206 Boehringer Ingelheim Investigational Site
Westbury on Trym
205.346.205 Boehringer Ingelheim Investigational Site
Windsor

Other trials in United Kingdom

Slovakia6 sites

205.346.302 Boehringer Ingelheim Investigational Site
Bratislava
205.346.305 Boehringer Ingelheim Investigational Site
Bratislava
205.346.301 Boehringer Ingelheim Investigational Site
Košice
205.346.303 Boehringer Ingelheim Investigational Site
Levica
205.346.304 Boehringer Ingelheim Investigational Site
Lučenec
205.346.306 Boehringer Ingelheim Investigational Site
Štúrovo

Other trials in Slovakia

About this study

Official title: A Randomized, Double-blind, Double-dummy, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium Inhalation Capsules 18 mcg Via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations q.i.d. in COPD Patients Currently Prescribed Combivent® Inhalation Aerosol CFC MDI

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: tiotropium, ipratropium bromide / albuterol
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
ipratropium bromide / albuterolDrug

What is being measured

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

Trough FEV1
Measured: after 12 weeks of treatment
FEV1 AUC0-6 hours
Measured: after 12 weeks of treatment

Secondary outcomes (15)

Peak FEV1
Measured: 12 weeks
Peak FEV1
Measured: after first dose and 6 week
FEV1 AUC0-6 hours
Measured: after first dose and 6 weeks
Trough FEV1
Measured: at 6 weeks
Peak FVC at all clinic visits
Measured: 12 weeks
AUC0-6 hours FVC at all clinic visits
Measured: 12 weeks
Trough FVC
Measured: at 6 and 12 weeks
Individual FEV1 measurements
Measured: 12 weeks
Individual FVC measurements
Measured: 12 weeks
Use of Albuterol (scheduled and rescue)
Measured: 12 weeks
Patient Global Evaluation
Measured: 12 weeks
Physician Global Evaluation
Measured: 12 weeks
PEFR (Peak expiratory flow rate) measured by the patient at home twice daily
Measured: 12 weeks
Occurrence of adverse events
Measured: 12 weeks
Vital Signs
Measured: 12 weeks

Timeline

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

4 Oct 20068 Oct 2007

First posted17 Oct 2006 (estimated)
Study start4 Oct 2006
Primary completion8 Oct 2007

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 4
Primary purpose: Treatment
Enrolment: 327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00388882
Sponsor's protocol ID: 205.346
Other IDs: EudraCT 2006-000822-30
Status last verified: Nov 2023
First submitted: 16 Oct 2006
Last updated: 1 Dec 2023
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 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Double-dummy, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium Inhalation Capsules 18 mcg Via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations q.i.d. in COPD Patients Currently Prescribed Combivent® Inhalation Aerosol CFC MDI
ClinicalTrials.gov ID: NCT00388882
Acronym / sponsor ID: 205.346
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 327 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 4 Oct 2006 (actual)
Primary completion: 8 Oct 2007 (actual)
First posted: 17 Oct 2006 (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

Who may qualify

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

Key inclusion criteria (6 listed)

Diagnosis of COPD
Age: >= 40 years
Current or ex-smoker with a >= 10 pack-year smoking history
Use of Combivent® MDI for >= 1 month prior to Visit 1 Spirometric criteria (determined at study visits):
Post-bronchodilator FEV1 <= 70% (Visit 1)

Key exclusion criteria (15 listed)

Clinical history of asthma
History of thoracotomy with pulmonary resection
History of CF, alpha 1 antitrypsin deficiency or interstitial lung disease
Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain from using oxygen during PFTs
Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1

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	–
ipratropium bromide / albuterol	Drug	–

Primary outcome

Trough FEV1
Time frame: after 12 weeks of treatment
FEV1 AUC0-6 hours
Time frame: after 12 weeks of treatment

15 secondary outcomes

Peak FEV1
Time frame: 12 weeks
Peak FEV1
Time frame: after first dose and 6 week
FEV1 AUC0-6 hours
Time frame: after first dose and 6 weeks
Trough FEV1
Time frame: at 6 weeks
Peak FVC at all clinic visits
Time frame: 12 weeks
AUC0-6 hours FVC at all clinic visits
Time frame: 12 weeks
Trough FVC
Time frame: at 6 and 12 weeks
Individual FEV1 measurements
Time frame: 12 weeks
Individual FVC measurements
Time frame: 12 weeks
Use of Albuterol (scheduled and rescue)
Time frame: 12 weeks
Patient Global Evaluation
Time frame: 12 weeks
Physician Global Evaluation
Time frame: 12 weeks
PEFR (Peak expiratory flow rate) measured by the patient at home twice daily
Time frame: 12 weeks
Occurrence of adverse events
Time frame: 12 weeks
Vital Signs
Time frame: 12 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 Dec 2023.
Related InfoLink provided by the sponsor.
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 chair

Boehringer Ingelheim

40 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tiotropium and ipratropium bromide / albuterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 40 sites in 5 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 6 inclusion and 15 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Lithuania, Argentina, United Kingdom, Slovakia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 (time frame: after 12 weeks of treatment). The study lists 2 primary outcomes in all. 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 NCT00388882.

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 Dec 2023.