Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00388882
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 327
- 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)
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Trough FEV1 after 12 weeks of treatment FEV1 AUC0-6 hours after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Trough FVC at 6 and 12 weeks Individual FVC measurements 12 weeks FEV1 AUC0-6 hours after first dose and 6 weeks Peak FEV1 after first dose and 6 week Individual FEV1 measurements 12 weeks Use of Albuterol (scheduled and rescue) 12 weeks Patient Global Evaluation 12 weeks Physician Global Evaluation 12 weeks Occurrence of adverse events 12 weeks Vital Signs 12 weeks Trough FEV1 at 6 weeks Peak FVC at all clinic visits 12 weeks AUC0-6 hours FVC at all clinic visits 12 weeks PEFR (Peak expiratory flow rate) measured by the patient at home twice daily 12 weeks
Trial Locations
- Locations (40)
205.346.105 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
205.346.509
🇦🇷Rosario, Santa Fe, Argentina
205.346.511
🇦🇷Rosario, Santa Fé, Argentina
205.346.109 Boehringer Ingelheim Investigational Site
🇺🇸Shreveport, Louisiana, United States
205.346.510
🇦🇷Bs As, Argentina
205.346.110 Boehringer Ingelheim Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States
205.346.103 Boehringer Ingelheim Investigational Site
🇺🇸Spartanburg, South Carolina, United States
205.346.411 Boehringer Ingelheim Investigational Site
🇱🇹Klaipeda, Lithuania
205.346.406 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
205.346.508
🇦🇷Buenos Airess, Argentina
205.346.505
🇦🇷Mendoza, Argentina
205.346.101 Boehringer Ingelheim Investigational Site
🇺🇸Torrance, California, United States
205.346.502
🇦🇷Buenos Aires, Argentina
205.346.503
🇦🇷Buenos Aires, Argentina
205.346.107 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
205.346.108 Boehringer Ingelheim Investigational Site
🇺🇸Sepulveda, California, United States
205.346.104 Boehringer Ingelheim Investigational Site
🇺🇸Lakewood, California, United States
205.346.106 Boehringer Ingelheim Investigational Site
🇺🇸Wheat Ridge, Colorado, United States
205.346.401 Boehringer Ingelheim Investigational Site
🇱🇹Alytus, Lithuania
205.346.302 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
205.346.405 Boehringer Ingelheim Investigational Site
🇱🇹Kaunas, Lithuania
205.346.409 Boehringer Ingelheim Investigational Site
🇱🇹Siauliai, Lithuania
205.346.402 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
205.346.209 Boehringer Ingelheim Investigational Site
🇬🇧Swansea, United Kingdom
205.346.301 Boehringer Ingelheim Investigational Site
🇸🇰Kosice, Slovakia
205.346.203 Boehringer Ingelheim Investigational Site
🇬🇧Greenisland, United Kingdom
205.346.205 Boehringer Ingelheim Investigational Site
🇬🇧Windsor, United Kingdom
205.346.407 Boehringer Ingelheim Investigational Site
🇱🇹Vilnius, Lithuania
205.346.306 Boehringer Ingelheim Investigational Site
🇸🇰Sturovo, Slovakia
205.346.408 Boehringer Ingelheim Investigational Site
🇱🇹Utena, Lithuania
205.346.303 Boehringer Ingelheim Investigational Site
🇸🇰Levica, Slovakia
205.346.304 Boehringer Ingelheim Investigational Site
🇸🇰Lucenec, Slovakia
205.346.305 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
205.346.204 Boehringer Ingelheim Investigational Site
🇬🇧Aylesbury, United Kingdom
205.346.102 Boehringer Ingelheim Investigational Site
🇺🇸Coeur d'Alene, Idaho, United States
205.346.404 Boehringer Ingelheim Investigational Site
🇱🇹Kaunas, Lithuania
205.346.504 Instituto de Patologías Respiratorias
🇦🇷San Miguel de Tucumán, Argentina
205.346.201 Boehringer Ingelheim Investigational Site
🇬🇧Nottingham, United Kingdom
205.346.207 Boehringer Ingelheim Investigational Site
🇬🇧Soham, United Kingdom
205.346.206 Boehringer Ingelheim Investigational Site
🇬🇧Westbury On Trym, United Kingdom