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

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: tiotropium (Drug); ipratropium bromide / albuterol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

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.

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

Study design: Treatment, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Trough and AUC0-6 FEV1 after 12 weeks.

Secondary outcome: Peak FEV1, FVC (trough, peak, AUC0-6), FEV1 and FVC at each timepoint, trough FEV1 at 6 weeks, albuterol use, Patient and Physician Global Evaluations, daily PEFR

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

Inclusion_Criteria:? 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)

Exclusion Criteria:

Exclusion_Criteria:

- 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 fr om

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

Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States

Boehringer Ingelheim Investigational Site, Tucson, Arizona, United States

Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States

Boehringer Ingelheim Investigational Site, Palo Alto, California, United States

Boehringer Ingelheim Investigational Site, Long Beach, California, United States

Boehringer Ingelheim Investigational Site, Fort Collins, Colorado, United States

Boehringer Ingelheim Investigational Site, West Haven, Connecticut, United States

Boehringer Ingelheim Investigational Site, Bay Pines, Florida, United States

Boehringer Ingelheim Investigational Site, Decatur, Georgia, United States

Boehringer Ingelheim Investigational Site, North Chicago, Illinois, United States

Boehringer Ingelheim Investigational Site, Indiananapolis, Indiana, United States

Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States

Boehringer Ingelheim Investigational Site, Baltimore, Maryland, United States

Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States

Boehringer Ingelheim Investigational Site, Ann Arbor, Michigan, United States

Boehringer Ingelheim Investigational Site, Minneapolis, Minnesota, United States

Boehringer Ingelheim Investigational Site, Kansas City, Missouri, United States

Boehringer Ingelheim Investigational Site, Reno, Nevada, United States

Boehringer Ingelheim Investigational Site, East Orange, New Jersey, United States

Boehringer Ingelheim Investigational Site, Buffalo, New York, United States

Boehringer Ingelheim Investigational Site, Brooklyn, New York, United States

Boehringer Ingelheim Investigational Site, Cleveland, Ohio, United States

Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States

Boehringer Ingelheim Investigational Site, Portland, Oregon, United States

Boehringer Ingelheim Investigational Site, Providence, Rhode Island, United States

Boehringer Ingelheim Investigational Site, Greenville, South Carolina, United States

Boehringer Ingelheim Investigational Site, Houston, Texas, United States

Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States

Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States

Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States

Starting date: July 2006
Last updated: June 10, 2008