A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients. - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00359788

Purpose

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.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: tiotropium Drug: Combivent (Ipratropium/Albuterol)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy 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

Resource links provided by NLM:

MedlinePlus related topics: Ataxia Telangiectasia COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Albuterol Ipratropium bromide Ipratropium Tiotropium bromide Tiotropium Combivent

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks [ Time Frame: 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 [ Time Frame: Baseline and 12 Weeks ]

Secondary Outcome Measures:

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 ]
FVC at 2 Hours on Day 1 [ Time Frame: 2 hour ]
FVC at 3 Hours on Day 1 [ Time Frame: 3 hour ]
FVC at 4 Hours on Day 1 [ Time Frame: 4 hour ]
FVC at 6 Hours on Day 1 [ Time Frame: 6 hour ]
FVC at -10 Minutes at Week 6 [ Time Frame: 10 minutes before dosing ]
FVC at 15 Minutes at Week 6 [ Time Frame: 15 minutes ]
FVC at 30 Minutes at Week 6 [ Time Frame: 30 minutes ]
FVC at 1 Hour at Week 6 [ Time Frame: 1 hour ]
FVC at 2 Hours at Week 6 [ Time Frame: 2 hour ]
FVC at 3 Hours at Week 6 [ Time Frame: 3 hour ]
FVC at 4 Hours at Week 6 [ Time Frame: 4 hour ]
FVC at 6 Hours at Week 6 [ Time Frame: 6 hour ]
FVC at -10 Minutes at Week 12 [ Time Frame: 10 minutes before dosing ]
FVC at 15 Minutes at Week 12 [ Time Frame: 15 minutes ]
FVC at 30 Minutes at Week 12 [ Time Frame: 30 minutes ]
FVC at 1 Hour at Week 12 [ Time Frame: 1 hour ]
FVC at 2 Hours at Week 12 [ Time Frame: 2 hour ]
FVC at 3 Hours at Week 12 [ Time Frame: 3 hour ]
FVC at 4 Hours at Week 12 [ Time Frame: 4 hour ]
FVC at 6 Hours at Week 12 [ Time Frame: 6 hour ]
Day Time Albuterol Use During Week 1 [ Time Frame: Week 1 ]
Day Time Albuterol Use During Week 2 [ Time Frame: Week 2 ]
Day Time Albuterol Use During Week 3 [ Time Frame: Week 3 ]
Day Time Albuterol Use During Week 4 [ Time Frame: Week 4 ]
Day Time Albuterol Use During Week 5 [ Time Frame: Week 5 ]
Day Time Albuterol Use During Week 6 [ Time Frame: Week 6 ]
Day Time Albuterol Use During Week 7 [ Time Frame: Week 7 ]
Day Time Albuterol Use During Week 8 [ Time Frame: Week 8 ]
Day Time Albuterol Use During Week 9 [ Time Frame: Week 9 ]
Day Time Albuterol Use During Week 10 [ Time Frame: Week 10 ]
Day Time Albuterol Use During Week 11 [ Time Frame: Week 11 ]
Day Time Albuterol Use During Week 12 [ Time Frame: Week 12 ]
Night Time Albuterol Use During Week 1 [ Time Frame: Week 1 ]
Night Time Albuterol Use During Week 2 [ Time Frame: Week 2 ]
Night Time Albuterol Use During Week 3 [ Time Frame: Week 3 ]
Night Time Albuterol Use During Week 4 [ Time Frame: Week 4 ]
Night Time Albuterol Use During Week 5 [ Time Frame: Week 5 ]
Night Time Albuterol Use During Week 6 [ Time Frame: Week 6 ]
Night Time Albuterol Use During Week 7 [ Time Frame: Week 7 ]
Night Time Albuterol Use During Week 8 [ Time Frame: Week 8 ]
Night Time Albuterol Use During Week 9 [ Time Frame: Week 9 ]
Night Time Albuterol Use During Week 10 [ Time Frame: Week 10 ]
Night Time Albuterol Use During Week 11 [ Time Frame: Week 11 ]
Night Time Albuterol Use During Week 12 [ Time Frame: Week 12 ]
Morning Peak Expiratory Flow Rate (PEFR) at Week 1 [ Time Frame: Week 1 ]
Morning PEFR at Week 2 [ Time Frame: Week 2 ]
Morning PEFR at Week 3 [ Time Frame: Week 3 ]
Morning PEFR at Week 4 [ Time Frame: Week 4 ]
Morning PEFR at Week 5 [ Time Frame: Week 5 ]
Morning PEFR at Week 6 [ Time Frame: Week 6 ]
Morning PEFR at Week 7 [ Time Frame: Week 7 ]
Morning PEFR at Week 8 [ Time Frame: Week 8 ]
Morning PEFR at Week 9 [ Time Frame: Week 9 ]
Morning PEFR at Week 10 [ Time Frame: Week 10 ]
Morning PEFR at Week 11 [ Time Frame: Week 11 ]
Morning PEFR at Week 12 [ Time Frame: Week 12 ]
Evening PEFR at Week 1 [ Time Frame: Week 1 ]
Evening PEFR at Week 2 [ Time Frame: Week 2 ]
Evening PEFR at Week 3 [ Time Frame: Week 3 ]
Evening PEFR at Week 1 [ Time Frame: Week 4 ]
Evening PEFR at Week 5 [ Time Frame: Week 5 ]
Evening PEFR at Week 6 [ Time Frame: Week 6 ]
Evening PEFR at Week 7 [ Time Frame: Week 7 ]
Evening PEFR at Week 8 [ Time Frame: Week 8 ]
Evening PEFR at Week 9 [ Time Frame: Week 9 ]
Evening PEFR at Week 10 [ Time Frame: Week 10 ]
Evening PEFR at Week 11 [ Time Frame: Week 11 ]
Evening PEFR at Week 12 [ Time Frame: Week 12 ]
Patient Global Evaluation [ Time Frame: Week 6 ]
Patient Global Evaluation [ Time Frame: Week 12 ]
Physician Global Evaluation [ Time Frame: Week 6 ]
Physician Global Evaluation [ Time Frame: Week 12 ]

Enrollment:	349
Study Start Date:	July 2006
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years

Current or ex-smoker with a >= 10 pack-year smoking history
Use of Combivent® Metered Dose Inhaler (MDI)for >= 1 month prior to Visit 1

Spirometric criteria (determined at study visits):

Post-bronchodilator Forced Expiratory Volume in one second (FEV1) <= 70% (Visit 1)
Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/Forced Vital Capacity (FVC) <= 70% (Visit 2)

Exclusion Criteria:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359788

Hide Study Locations

Locations

United States, Alabama
205.325.904 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arizona
205.325.909 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
205.325.925 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
205.325.911 Boehringer Ingelheim Investigational Site
Palo Alto, California, United States
205.325.912 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
United States, Colorado
205.325.935 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado, United States
United States, Connecticut
205.325.903 Boehringer Ingelheim Investigational Site
West Haven, Connecticut, United States
United States, Florida
205.325.905 Boehringer Ingelheim Investigational Site
Bay Pines, Florida, United States
United States, Georgia
205.325.922 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
United States, Illinois
205.325.907 Boehringer Ingelheim Investigational Site
North Chicago, Illinois, United States
United States, Indiana
205.325.928 Boehringer Ingelheim Investigational Site
Indiananapolis, Indiana, United States
United States, Kansas
205.325.923 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
United States, Maryland
205.325.902 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
United States, Massachusetts
205.325.908 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, Michigan
205.325.920 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan, United States
205.325.932 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan, United States
United States, Minnesota
205.325.915 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
United States, Missouri
205.325.914 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
United States, Nevada
205.325.910 Boehringer Ingelheim Investigational Site
Reno, Nevada, United States
United States, New Jersey
205.325.924 Boehringer Ingelheim Investigational Site
East Orange, New Jersey, United States
United States, New York
205.325.917 Boehringer Ingelheim Investigational Site
Buffalo, New York, United States
205.325.921 Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
United States, Ohio
205.325.901 Boehringer Ingelheim Investigational Site
Cleveland, Ohio, United States
205.325.926 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oregon
205.325.931 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Rhode Island
205.325.929 Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
United States, South Carolina
205.325.936 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
United States, Texas
205.325.918 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
205.325.927 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Utah
205.325.919 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
United States, Virginia
205.325.906 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	205.325
Study First Received:	August 1, 2006
Results First Received:	April 17, 2009
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00359788 History of Changes
Health Authority:	United States: Food and Drug Administration