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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
327
Trough FEV1
Time frame: after 12 weeks of treatment
FEV1 AUC0-6 hours
Time frame: after 12 weeks of treatment
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
205.346.107 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
205.346.104 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
205.346.108 Boehringer Ingelheim Investigational Site
Sepulveda, California, United States
205.346.101 Boehringer Ingelheim Investigational Site
Torrance, California, United States
205.346.106 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
205.346.102 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
205.346.109 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
205.346.110 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
205.346.105 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
205.346.103 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
...and 30 more locations
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