A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00359788
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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 currently prescribed Combivent® MDI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 349
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)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks 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 Baseline and 12 Weeks Average hourly FEV1 AUC0-6 minus baseline FEV1
- Secondary Outcome Measures
Name Time Method Day Time Albuterol Use During Week 11 Week 11 Puffs of rescue albuterol used during the day in week 11
Night Time Albuterol Use During Week 1 Week 1 Morning Peak Expiratory Flow Rate (PEFR) at Week 1 Week 1 Morning PEFR at Week 2 Week 2 Weekly means for morning PEFR
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1 Day 1 Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6 Baseline and 6 weeks Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12 Baseline and 12 weeks Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks Baseline and 12 weeks Trough FVC is measured 10 minutes before drug administration
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks Baseline and 12 Weeks Average hourly FVC AUC0-6 minus baseline FVC
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks Baseline and 6 weeks Trough FVC is measured 10 minutes before drug administration
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1 Day 1 Average hourly FVC AUC0-6 minus baseline FVC
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks Baseline and 6 Weeks Average hourly FVC AUC0-6 minus baseline FVC
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks Baseline and 6 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) on Day 1 Day 1 (after first dose) Average hourly FEV1 AUC0-6 minus baseline FEV1
Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6 Baseline and week 6 Average hourly FEV1 AUC0-6 minus baseline FEV1
Morning PEFR at Week 3 Week 3 Weekly means for morning PEFR
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1 Day 1 Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6 baseline and 6 Weeks (after first dose) Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12 Baseline and 12 Weeks Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication
FEV1 at 15 Minutes on Day 1 15 minutes FEV1 at 30 Minutes on Day 1 30 minutes FEV1 at 1 Hour on Day 1 1 hour FEV1 at 2 Hours on Day 1 2 hour FEV1 at 3 Hours on Day 1 3 hour FEV1 at 4 Hours on Day 1 4 hour FEV1 at 6 Hours on Day 1 6 hours Morning PEFR at Week 4 Week 4 Weekly means for morning PEFR
FEV1 at -10 Minutes at Week 6 10 minutes before dosing FEV1 at 15 Minutes at Week 6 15 minutes FEV1 at 30 Minutes at Week 6 30 minutes FEV1 at 1 Hour at Week 6 1 hour FEV1 at 2 Hours at Week 6 2 hour FEV1 at 3 Hours at Week 6 3 hour FEV1 at 4 Hours at Week 6 4 hour FEV1 at 6 Hours at Week 6 6 hour FEV1 at -10 Minutes at Week 12 10 minutes before dosing FEV1 at 15 Minutes at Week 12 15 minutes FEV1 at 30 Minutes at Week 12 30 minutes FEV1 at 1 Hour at Week 12 1 hour FEV1 at 2 Hours at Week 12 2 hour FEV1 at 3 Hours at Week 12 3 hour FEV1 at 4 Hours at Week 12 4 hour FEV1 at 6 Hours at Week 12 6 hour FVC at 15 Minutes on Day 1 15 minutes FVC at 30 Minutes on Day 1 30 minutes FVC at 1 Hour on Day 1 1 hour FVC at 2 Hours on Day 1 2 hour FVC at 3 Hours on Day 1 3 hour FVC at 4 Hours on Day 1 4 hour FVC at 6 Hours on Day 1 6 hour FVC at -10 Minutes at Week 6 10 minutes before dosing FVC at 15 Minutes at Week 6 15 minutes Morning PEFR at Week 5 Week 5 Weekly means for morning PEFR
Morning PEFR at Week 6 Week 6 Weekly means for morning PEFR
FVC at 30 Minutes at Week 6 30 minutes FVC at 1 Hour at Week 6 1 hour FVC at 2 Hours at Week 6 2 hour FVC at 3 Hours at Week 6 3 hour FVC at 4 Hours at Week 6 4 hour FVC at 6 Hours at Week 6 6 hour FVC at -10 Minutes at Week 12 10 minutes before dosing FVC at 15 Minutes at Week 12 15 minutes FVC at 30 Minutes at Week 12 30 minutes FVC at 1 Hour at Week 12 1 hour FVC at 2 Hours at Week 12 2 hour FVC at 3 Hours at Week 12 3 hour FVC at 4 Hours at Week 12 4 hour FVC at 6 Hours at Week 12 6 hour Day Time Albuterol Use During Week 1 Week 1 Puffs of rescue albuterol used during the day in week 1
Day Time Albuterol Use During Week 2 Week 2 Puffs of rescue albuterol used during the day in week 2
Day Time Albuterol Use During Week 3 Week 3 Puffs of rescue albuterol used during the day in week 3
Day Time Albuterol Use During Week 4 Week 4 Puffs of rescue albuterol used during the day in week 4
Day Time Albuterol Use During Week 5 Week 5 Puffs of rescue albuterol used during the day in week 5
Day Time Albuterol Use During Week 6 Week 6 Puffs of rescue albuterol used during the day in week 6
Night Time Albuterol Use During Week 3 Week 3 Puffs of rescue albuterol used during the night in week 3
Night Time Albuterol Use During Week 4 Week 4 Puffs of rescue albuterol used during the night in week 4
Night Time Albuterol Use During Week 5 Week 5 Puffs of rescue albuterol used during the night in week 5
Night Time Albuterol Use During Week 11 Week 11 Puffs of rescue albuterol used during the night in week 11
Day Time Albuterol Use During Week 7 Week 7 Puffs of rescue albuterol used during the day in week 7
Day Time Albuterol Use During Week 8 Week 8 Puffs of rescue albuterol used during the day in week 8
Day Time Albuterol Use During Week 12 Week 12 Puffs of rescue albuterol used during the day in week 12
Night Time Albuterol Use During Week 7 Week 7 Puffs of rescue albuterol used during the night in week 7
Night Time Albuterol Use During Week 8 Week 8 Puffs of rescue albuterol used during the night in week 8
Day Time Albuterol Use During Week 9 Week 9 Puffs of rescue albuterol used during the day in week 9
Day Time Albuterol Use During Week 10 Week 10 Puffs of rescue albuterol used during the day in week 10
Night Time Albuterol Use During Week 2 Week 2 Puffs of rescue albuterol used during the night in week 2
Night Time Albuterol Use During Week 9 Week 9 Puffs of rescue albuterol used during the night in week 9
Night Time Albuterol Use During Week 10 Week 10 Puffs of rescue albuterol used during the night in week 10
Morning PEFR at Week 7 Week 7 Weekly means for morning PEFR
Night Time Albuterol Use During Week 6 Week 6 Puffs of rescue albuterol used during the night in week 6
Night Time Albuterol Use During Week 12 Week 12 Puffs of rescue albuterol used during the night in week 12
Morning PEFR at Week 8 Week 8 Weekly means for morning PEFR
Morning PEFR at Week 9 Week 9 Weekly means for morning PEFR
Morning PEFR at Week 10 Week 10 Weekly means for morning PEFR
Morning PEFR at Week 11 Week 11 Weekly means for morning PEFR
Morning PEFR at Week 12 Week 12 Weekly means for morning PEFR
Evening PEFR at Week 1 Week 1 Weekly means for evening PEFR
Evening PEFR at Week 2 Week 2 Weekly means for evening PEFR
Evening PEFR at Week 3 Week 3 Weekly means for evening PEFR
Evening PEFR at Week 4 Week 4 Weekly means for evening PEFR
Evening PEFR at Week 5 Week 5 Weekly means for evening PEFR
Evening PEFR at Week 6 Week 6 Weekly means for evening PEFR
Evening PEFR at Week 7 Week 7 Weekly means for evening PEFR
Evening PEFR at Week 8 Week 8 Weekly means for evening PEFR
Evening PEFR at Week 9 Week 9 Weekly means for evening PEFR
Evening PEFR at Week 10 Week 10 Weekly means for evening PEFR
Evening PEFR at Week 11 Week 11 Weekly means for evening PEFR
Evening PEFR at Week 12 Week 12 Weekly means for evening PEFR
Patient Global Evaluation Week 12 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).
Physician Global Evaluation Week 12 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).
Trial Locations
- Locations (31)
205.325.935 Boehringer Ingelheim Investigational Site
🇺🇸Fort Collins, Colorado, United States
205.325.917 Boehringer Ingelheim Investigational Site
🇺🇸Buffalo, New York, United States
205.325.924 Boehringer Ingelheim Investigational Site
🇺🇸East Orange, New Jersey, United States
205.325.903 Boehringer Ingelheim Investigational Site
🇺🇸West Haven, Connecticut, United States
205.325.905 Boehringer Ingelheim Investigational Site
🇺🇸Bay Pines, Florida, United States
205.325.921 Boehringer Ingelheim Investigational Site
🇺🇸Brooklyn, New York, United States
205.325.936 Boehringer Ingelheim Investigational Site
🇺🇸Greenville, South Carolina, United States
205.325.904 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
205.325.925 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
205.325.902 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
205.325.908 Boehringer Ingelheim Investigational Site
🇺🇸Boston, Massachusetts, United States
205.325.915 Boehringer Ingelheim Investigational Site
🇺🇸Minneapolis, Minnesota, United States
205.325.926 Boehringer Ingelheim Investigational Site
🇺🇸Cincinnati, Ohio, United States
205.325.901 Boehringer Ingelheim Investigational Site
🇺🇸Cleveland, Ohio, United States
205.325.931 Boehringer Ingelheim Investigational Site
🇺🇸Portland, Oregon, United States
205.325.918 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
205.325.927 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
205.325.919 Boehringer Ingelheim Investigational Site
🇺🇸Salt Lake City, Utah, United States
205.325.912 Boehringer Ingelheim Investigational Site
🇺🇸Long Beach, California, United States
205.325.909 Boehringer Ingelheim Investigational Site
🇺🇸Tucson, Arizona, United States
205.325.911 Boehringer Ingelheim Investigational Site
🇺🇸Palo Alto, California, United States
205.325.922 Boehringer Ingelheim Investigational Site
🇺🇸Decatur, Georgia, United States
205.325.928 Boehringer Ingelheim Investigational Site
🇺🇸Indiananapolis, Indiana, United States
205.325.907 Boehringer Ingelheim Investigational Site
🇺🇸North Chicago, Illinois, United States
205.325.923 Boehringer Ingelheim Investigational Site
🇺🇸Wichita, Kansas, United States
205.325.910 Boehringer Ingelheim Investigational Site
🇺🇸Reno, Nevada, United States
205.325.914 Boehringer Ingelheim Investigational Site
🇺🇸Kansas City, Missouri, United States
205.325.920 Boehringer Ingelheim Investigational Site
🇺🇸Ann Arbor, Michigan, United States
205.325.906 Boehringer Ingelheim Investigational Site
🇺🇸Richmond, Virginia, United States
205.325.932 Boehringer Ingelheim Investigational Site
🇺🇸Ann Arbor, Michigan, United States
205.325.929 Boehringer Ingelheim Investigational Site
🇺🇸Providence, Rhode Island, United States