A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

Completed · Phase 4

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00359788

Run by

Boehringer Ingelheim

People needed

349

Starts

2006-07-01

Last updated by the study team

2014-05-16

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• 205.325.904 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 205.325.925 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 205.325.909 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• 205.325.912 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
• 205.325.911 Boehringer Ingelheim Investigational Site — Palo Alto, California, United States
• 205.325.935 Boehringer Ingelheim Investigational Site — Fort Collins, Colorado, 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
• 205.325.922 Boehringer Ingelheim Investigational Site — Decatur, Georgia, United States
• 205.325.907 Boehringer Ingelheim Investigational Site — North Chicago, Illinois, United States
• 205.325.928 Boehringer Ingelheim Investigational Site — Indiananapolis, Indiana, United States
• 205.325.923 Boehringer Ingelheim Investigational Site — Wichita, Kansas, United States
• 205.325.902 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• 205.325.908 Boehringer Ingelheim Investigational Site — Boston, Massachusetts, United States
• 205.325.920 Boehringer Ingelheim Investigational Site — Ann Arbor, Michigan, United States
• 205.325.932 Boehringer Ingelheim Investigational Site — Ann Arbor, Michigan, United States
• 205.325.915 Boehringer Ingelheim Investigational Site — Minneapolis, Minnesota, United States
• 205.325.914 Boehringer Ingelheim Investigational Site — Kansas City, Missouri, United States
• 205.325.910 Boehringer Ingelheim Investigational Site — Reno, Nevada, United States
• 205.325.924 Boehringer Ingelheim Investigational Site — East Orange, New Jersey, United States
• 205.325.921 Boehringer Ingelheim Investigational Site — Brooklyn, New York, United States
• 205.325.917 Boehringer Ingelheim Investigational Site — Buffalo, New York, 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

Full record on ClinicalTrials.gov

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