Pulmonary Disease, Chronic ObstructivePhase 4NCT00359788
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
A Phase 4 study testing tiotropium and Combivent (Ipratropium/Albuterol) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 31 sites in United States.
Trial summary
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients… 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 Combivent (Ipratropium/Albuterol)
- How many people
- 349 participants
- Where
- 31 sitesUnited States
- Study dates
- Jul 2006to Apr 2008
- Phase
- Phase 4
- 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
Who may be able to join
None listed.
Who cannot join
- Clinical history of asthma
- History of thoracotomy with pulmonary resection
- History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease
- Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests
- Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
- Recent history 6 months or less of Myocardial Infarction
Show all 15Show fewer
- Unstable or life-threatening cardiac arrhythmias
- Hospitalization for Congestive Heart Failure 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
31 sites in 1 country.
31 sites in 1 country
United States31 sites
205.325.920 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan
205.325.932 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan
205.325.902 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
205.325.905 Boehringer Ingelheim Investigational Site
Bay Pines, Florida
205.325.904 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
205.325.908 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
205.325.921 Boehringer Ingelheim Investigational Site
Brooklyn, New York
205.325.917 Boehringer Ingelheim Investigational Site
Buffalo, New York
205.325.926 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.325.901 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
205.325.922 Boehringer Ingelheim Investigational Site
Decatur, Georgia
205.325.924 Boehringer Ingelheim Investigational Site
East Orange, New Jersey
205.325.935 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado
205.325.936 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
205.325.918 Boehringer Ingelheim Investigational Site
Houston, Texas
205.325.928 Boehringer Ingelheim Investigational Site
Indiananapolis, Indiana
205.325.914 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
205.325.912 Boehringer Ingelheim Investigational Site
Long Beach, California
205.325.915 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
205.325.907 Boehringer Ingelheim Investigational Site
North Chicago, Illinois
205.325.911 Boehringer Ingelheim Investigational Site
Palo Alto, California
205.325.925 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
205.325.931 Boehringer Ingelheim Investigational Site
Portland, Oregon
205.325.929 Boehringer Ingelheim Investigational Site
Providence, Rhode Island
205.325.910 Boehringer Ingelheim Investigational Site
Reno, Nevada
205.325.906 Boehringer Ingelheim Investigational Site
Richmond, Virginia
205.325.919 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
205.325.927 Boehringer Ingelheim Investigational Site
San Antonio, Texas
205.325.909 Boehringer Ingelheim Investigational Site
Tucson, Arizona
205.325.903 Boehringer Ingelheim Investigational Site
West Haven, Connecticut
205.325.923 Boehringer Ingelheim Investigational Site
Wichita, Kansas
About this study
Official title: A Randomized, Double-blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 mcg Daily to Combivent MDI 2 Actuations Qid in COPD Patients Previously Prescribed Combivent MDI
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium, Combivent (Ipratropium/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
Combivent (Ipratropium/Albuterol)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks
Trough FEV1 is measured 10 minutes before drug administration
Measured: Baseline and 12 Weeks
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Average hourly FEV1 AUC0-6 minus baseline FEV1
Measured: Baseline and 12 Weeks
Secondary outcomes (112)
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks
Trough FEV1 is measured 10 minutes before drug administration
Measured: Baseline and 6 Weeks
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Average hourly FEV1 AUC0-6 minus baseline FEV1
Measured: Day 1 (after first dose)
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6
Average hourly FEV1 AUC0-6 minus baseline FEV1
Measured: Baseline and week 6
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Measured: Day 1
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Measured: Baseline and 6 weeks
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12
Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Measured: Baseline and 12 weeks
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks
Trough FVC is measured 10 minutes before drug administration
Measured: Baseline and 12 weeks
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Average hourly FVC AUC0-6 minus baseline FVC
Measured: Baseline and 12 Weeks
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks
Trough FVC is measured 10 minutes before drug administration
Measured: Baseline and 6 weeks
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Average hourly FVC AUC0-6 minus baseline FVC
Measured: Day 1
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks
Average hourly FVC AUC0-6 minus baseline FVC
Measured: Baseline and 6 Weeks
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Measured: Day 1
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Measured: baseline and 6 Weeks (after first dose)
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12
Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Measured: Baseline and 12 Weeks
FEV1 at 15 Minutes on Day 1
Measured: 15 minutes
FEV1 at 30 Minutes on Day 1
Measured: 30 minutes
FEV1 at 1 Hour on Day 1
Measured: 1 hour
FEV1 at 2 Hours on Day 1
Measured: 2 hour
FEV1 at 3 Hours on Day 1
Measured: 3 hour
FEV1 at 4 Hours on Day 1
Measured: 4 hour
FEV1 at 6 Hours on Day 1
Measured: 6 hours
FEV1 at -10 Minutes at Week 6
Measured: 10 minutes before dosing
FEV1 at 15 Minutes at Week 6
Measured: 15 minutes
FEV1 at 30 Minutes at Week 6
Measured: 30 minutes
FEV1 at 1 Hour at Week 6
Measured: 1 hour
FEV1 at 2 Hours at Week 6
Measured: 2 hour
FEV1 at 3 Hours at Week 6
Measured: 3 hour
FEV1 at 4 Hours at Week 6
Measured: 4 hour
FEV1 at 6 Hours at Week 6
Measured: 6 hour
FEV1 at -10 Minutes at Week 12
Measured: 10 minutes before dosing
FEV1 at 15 Minutes at Week 12
Measured: 15 minutes
FEV1 at 30 Minutes at Week 12
Measured: 30 minutes
FEV1 at 1 Hour at Week 12
Measured: 1 hour
FEV1 at 2 Hours at Week 12
Measured: 2 hour
FEV1 at 3 Hours at Week 12
Measured: 3 hour
FEV1 at 4 Hours at Week 12
Measured: 4 hour
FEV1 at 6 Hours at Week 12
Measured: 6 hour
FVC at 15 Minutes on Day 1
Measured: 15 minutes
FVC at 30 Minutes on Day 1
Measured: 30 minutes
FVC at 1 Hour on Day 1
Measured: 1 hour
FVC at 2 Hours on Day 1
Measured: 2 hour
FVC at 3 Hours on Day 1
Measured: 3 hour
FVC at 4 Hours on Day 1
Measured: 4 hour
FVC at 6 Hours on Day 1
Measured: 6 hour
FVC at -10 Minutes at Week 6
Measured: 10 minutes before dosing
FVC at 15 Minutes at Week 6
Measured: 15 minutes
FVC at 30 Minutes at Week 6
Measured: 30 minutes
FVC at 1 Hour at Week 6
Measured: 1 hour
FVC at 2 Hours at Week 6
Measured: 2 hour
FVC at 3 Hours at Week 6
Measured: 3 hour
FVC at 4 Hours at Week 6
Measured: 4 hour
FVC at 6 Hours at Week 6
Measured: 6 hour
FVC at -10 Minutes at Week 12
Measured: 10 minutes before dosing
FVC at 15 Minutes at Week 12
Measured: 15 minutes
FVC at 30 Minutes at Week 12
Measured: 30 minutes
FVC at 1 Hour at Week 12
Measured: 1 hour
FVC at 2 Hours at Week 12
Measured: 2 hour
FVC at 3 Hours at Week 12
Measured: 3 hour
FVC at 4 Hours at Week 12
Measured: 4 hour
FVC at 6 Hours at Week 12
Measured: 6 hour
Day Time Albuterol Use During Week 1
Puffs of rescue albuterol used during the day in week 1
Measured: Week 1
Day Time Albuterol Use During Week 2
Puffs of rescue albuterol used during the day in week 2
Measured: Week 2
Day Time Albuterol Use During Week 3
Puffs of rescue albuterol used during the day in week 3
Measured: Week 3
Day Time Albuterol Use During Week 4
Puffs of rescue albuterol used during the day in week 4
Measured: Week 4
Day Time Albuterol Use During Week 5
Puffs of rescue albuterol used during the day in week 5
Measured: Week 5
Day Time Albuterol Use During Week 6
Puffs of rescue albuterol used during the day in week 6
Measured: Week 6
Day Time Albuterol Use During Week 7
Puffs of rescue albuterol used during the day in week 7
Measured: Week 7
Day Time Albuterol Use During Week 8
Puffs of rescue albuterol used during the day in week 8
Measured: Week 8
Day Time Albuterol Use During Week 9
Puffs of rescue albuterol used during the day in week 9
Measured: Week 9
Day Time Albuterol Use During Week 10
Puffs of rescue albuterol used during the day in week 10
Measured: Week 10
Day Time Albuterol Use During Week 11
Puffs of rescue albuterol used during the day in week 11
Measured: Week 11
Day Time Albuterol Use During Week 12
Puffs of rescue albuterol used during the day in week 12
Measured: Week 12
Night Time Albuterol Use During Week 1
Measured: Week 1
Night Time Albuterol Use During Week 2
Puffs of rescue albuterol used during the night in week 2
Measured: Week 2
Night Time Albuterol Use During Week 3
Puffs of rescue albuterol used during the night in week 3
Measured: Week 3
Night Time Albuterol Use During Week 4
Puffs of rescue albuterol used during the night in week 4
Measured: Week 4
Night Time Albuterol Use During Week 5
Puffs of rescue albuterol used during the night in week 5
Measured: Week 5
Night Time Albuterol Use During Week 6
Puffs of rescue albuterol used during the night in week 6
Measured: Week 6
Night Time Albuterol Use During Week 7
Puffs of rescue albuterol used during the night in week 7
Measured: Week 7
Night Time Albuterol Use During Week 8
Puffs of rescue albuterol used during the night in week 8
Measured: Week 8
Night Time Albuterol Use During Week 9
Puffs of rescue albuterol used during the night in week 9
Measured: Week 9
Night Time Albuterol Use During Week 10
Puffs of rescue albuterol used during the night in week 10
Measured: Week 10
Night Time Albuterol Use During Week 11
Puffs of rescue albuterol used during the night in week 11
Measured: Week 11
Night Time Albuterol Use During Week 12
Puffs of rescue albuterol used during the night in week 12
Measured: Week 12
Morning Peak Expiratory Flow Rate (PEFR) at Week 1
Measured: Week 1
Morning PEFR at Week 2
Weekly means for morning PEFR
Measured: Week 2
Morning PEFR at Week 3
Weekly means for morning PEFR
Measured: Week 3
Morning PEFR at Week 4
Weekly means for morning PEFR
Measured: Week 4
Morning PEFR at Week 5
Weekly means for morning PEFR
Measured: Week 5
Morning PEFR at Week 6
Weekly means for morning PEFR
Measured: Week 6
Morning PEFR at Week 7
Weekly means for morning PEFR
Measured: Week 7
Morning PEFR at Week 8
Weekly means for morning PEFR
Measured: Week 8
Morning PEFR at Week 9
Weekly means for morning PEFR
Measured: Week 9
Morning PEFR at Week 10
Weekly means for morning PEFR
Measured: Week 10
Morning PEFR at Week 11
Weekly means for morning PEFR
Measured: Week 11
Morning PEFR at Week 12
Weekly means for morning PEFR
Measured: Week 12
Evening PEFR at Week 1
Weekly means for evening PEFR
Measured: Week 1
Evening PEFR at Week 2
Weekly means for evening PEFR
Measured: Week 2
Evening PEFR at Week 3
Weekly means for evening PEFR
Measured: Week 3
Evening PEFR at Week 4
Weekly means for evening PEFR
Measured: Week 4
Evening PEFR at Week 5
Weekly means for evening PEFR
Measured: Week 5
Evening PEFR at Week 6
Weekly means for evening PEFR
Measured: Week 6
Evening PEFR at Week 7
Weekly means for evening PEFR
Measured: Week 7
Evening PEFR at Week 8
Weekly means for evening PEFR
Measured: Week 8
Evening PEFR at Week 9
Weekly means for evening PEFR
Measured: Week 9
Evening PEFR at Week 10
Weekly means for evening PEFR
Measured: Week 10
Evening PEFR at Week 11
Weekly means for evening PEFR
Measured: Week 11
Evening PEFR at Week 12
Weekly means for evening PEFR
Measured: Week 12
Patient Global Evaluation
The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)
Measured: Week 6
Patient Global Evaluation
The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Measured: Week 12
Physician Global Evaluation
The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Measured: Week 6
Physician Global Evaluation
The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startJul 2006
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359788
- Sponsor's protocol ID
- 205.325
- Status last verified
- Sep 2013
- First submitted
- 1 Aug 2006
- Last updated
- 16 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 mcg Daily to Combivent MDI 2 Actuations Qid in COPD Patients Previously Prescribed Combivent MDI
- ClinicalTrials.gov ID
- NCT00359788
- Acronym / sponsor ID
- 205.325
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Apr 2008 (actual)
- First posted
- 2 Aug 2006 (estimated)
- Results
- Posted 10 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Clinical history of asthma
- History of thoracotomy with pulmonary resection
- History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease
- Daytime use of oxygen therapy for > 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests
- 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 | – |
| Combivent (Ipratropium/Albuterol) | Drug | – |
Primary outcome
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks
Time frame: Baseline and 12 Weeks
Trough FEV1 is measured 10 minutes before drug administration
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Time frame: Baseline and 12 Weeks
Average hourly FEV1 AUC0-6 minus baseline FEV1
112 secondary outcomes
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks
Time frame: Baseline and 6 Weeks
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Time frame: Day 1 (after first dose)
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6
Time frame: Baseline and week 6
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1
Time frame: Day 1
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6
Time frame: Baseline and 6 weeks
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12
Time frame: Baseline and 12 weeks
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
Time frame: Baseline and 12 Weeks
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks
Time frame: Baseline and 6 weeks
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
Time frame: Day 1
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks
Time frame: Baseline and 6 Weeks
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1
Time frame: Day 1
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6
Time frame: baseline and 6 Weeks (after first dose)
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12
Time frame: Baseline and 12 Weeks
FEV1 at 15 Minutes on Day 1
Time frame: 15 minutes
FEV1 at 30 Minutes on Day 1
Time frame: 30 minutes
FEV1 at 1 Hour on Day 1
Time frame: 1 hour
FEV1 at 2 Hours on Day 1
Time frame: 2 hour
FEV1 at 3 Hours on Day 1
Time frame: 3 hour
FEV1 at 4 Hours on Day 1
Time frame: 4 hour
FEV1 at 6 Hours on Day 1
Time frame: 6 hours
FEV1 at -10 Minutes at Week 6
Time frame: 10 minutes before dosing
FEV1 at 15 Minutes at Week 6
Time frame: 15 minutes
FEV1 at 30 Minutes at Week 6
Time frame: 30 minutes
FEV1 at 1 Hour at Week 6
Time frame: 1 hour
FEV1 at 2 Hours at Week 6
Time frame: 2 hour
FEV1 at 3 Hours at Week 6
Time frame: 3 hour
FEV1 at 4 Hours at Week 6
Time frame: 4 hour
FEV1 at 6 Hours at Week 6
Time frame: 6 hour
FEV1 at -10 Minutes at Week 12
Time frame: 10 minutes before dosing
FEV1 at 15 Minutes at Week 12
Time frame: 15 minutes
FEV1 at 30 Minutes at Week 12
Time frame: 30 minutes
FEV1 at 1 Hour at Week 12
Time frame: 1 hour
FEV1 at 2 Hours at Week 12
Time frame: 2 hour
FEV1 at 3 Hours at Week 12
Time frame: 3 hour
FEV1 at 4 Hours at Week 12
Time frame: 4 hour
FEV1 at 6 Hours at Week 12
Time frame: 6 hour
FVC at 15 Minutes on Day 1
Time frame: 15 minutes
FVC at 30 Minutes on Day 1
Time frame: 30 minutes
FVC at 1 Hour on Day 1
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tiotropium and Combivent (Ipratropium/Albuterol) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 31 sites in United States.
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 0 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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?
Yes. Results are posted in the registry (first posted 10 Nov 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?
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks (time frame: Baseline and 12 Weeks). 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?
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 16 May 2014.