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

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Combivent (Ipratropium/Albuterol); Drug: tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359788

205.325

Details and patient eligibility

About

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.

Enrollment: 349 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: 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)

Exclusion Criteria:

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