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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: tiotropium
• Drug: Combivent (Ipratropium/Albuterol)

Primary Measures

• Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks
  • Time Frame: Baseline and 12 Weeks
    
• Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
  • Time Frame: Baseline and 12 Weeks
    

Secondary Measures

• Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks
  • Time Frame: Baseline and 6 Weeks
    
• Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
  • Time Frame: Day 1 (after first dose)
    
• Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6
  • Time Frame: Baseline and week 6
    
• Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1
  • Time Frame: Day 1
    
• Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6
  • Time Frame: Baseline and 6 weeks
    
• Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12
  • Time Frame: Baseline and 12 weeks
    
• Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks
  • Time Frame: Baseline and 12 weeks
    
• Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
  • Time Frame: Baseline and 12 Weeks
    
• Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks
  • Time Frame: Baseline and 6 weeks
    
• Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
  • Time Frame: Day 1
    
• Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks
  • Time Frame: Baseline and 6 Weeks
    
• Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1
  • Time Frame: Day 1
    
• Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6
  • Time Frame: baseline and 6 Weeks (after first dose)
    
• Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12
  • Time Frame: Baseline and 12 Weeks
    
• FEV1 at 15 Minutes on Day 1
  • Time Frame: 15 minutes
    
• FEV1 at 30 Minutes on Day 1
  • Time Frame: 30 minutes
    
• FEV1 at 1 Hour on Day 1
  • Time Frame: 1 hour
    
• FEV1 at 2 Hours on Day 1
  • Time Frame: 2 hour
    
• FEV1 at 3 Hours on Day 1
  • Time Frame: 3 hour
    
• FEV1 at 4 Hours on Day 1
  • Time Frame: 4 hour
    
• FEV1 at 6 Hours on Day 1
  • Time Frame: 6 hours
    
• FEV1 at -10 Minutes at Week 6
  • Time Frame: 10 minutes before dosing
    
• FEV1 at 15 Minutes at Week 6
  • Time Frame: 15 minutes
    
• FEV1 at 30 Minutes at Week 6
  • Time Frame: 30 minutes
    
• FEV1 at 1 Hour at Week 6
  • Time Frame: 1 hour
    
• FEV1 at 2 Hours at Week 6
  • Time Frame: 2 hour
    
• FEV1 at 3 Hours at Week 6
  • Time Frame: 3 hour
    
• FEV1 at 4 Hours at Week 6
  • Time Frame: 4 hour
    
• FEV1 at 6 Hours at Week 6
  • Time Frame: 6 hour
    
• FEV1 at -10 Minutes at Week 12
  • Time Frame: 10 minutes before dosing
    
• FEV1 at 15 Minutes at Week 12
  • Time Frame: 15 minutes
    
• FEV1 at 30 Minutes at Week 12
  • Time Frame: 30 minutes
    
• FEV1 at 1 Hour at Week 12
  • Time Frame: 1 hour
    
• FEV1 at 2 Hours at Week 12
  • Time Frame: 2 hour
    
• FEV1 at 3 Hours at Week 12
  • Time Frame: 3 hour
    
• FEV1 at 4 Hours at Week 12
  • Time Frame: 4 hour
    
• FEV1 at 6 Hours at Week 12
  • Time Frame: 6 hour
    
• FVC at 15 Minutes on Day 1
  • Time Frame: 15 minutes
    
• FVC at 30 Minutes on Day 1
  • Time Frame: 30 minutes
    
• FVC at 1 Hour on Day 1
  • Time Frame: 1 hour
    
• FVC at 2 Hours on Day 1
  • Time Frame: 2 hour
    
• FVC at 3 Hours on Day 1
  • Time Frame: 3 hour
    
• FVC at 4 Hours on Day 1
  • Time Frame: 4 hour
    
• FVC at 6 Hours on Day 1
  • Time Frame: 6 hour
    
• FVC at -10 Minutes at Week 6
  • Time Frame: 10 minutes before dosing
    
• FVC at 15 Minutes at Week 6
  • Time Frame: 15 minutes
    
• FVC at 30 Minutes at Week 6
  • Time Frame: 30 minutes
    
• FVC at 1 Hour at Week 6
  • Time Frame: 1 hour
    
• FVC at 2 Hours at Week 6
  • Time Frame: 2 hour
    
• FVC at 3 Hours at Week 6
  • Time Frame: 3 hour
    
• FVC at 4 Hours at Week 6
  • Time Frame: 4 hour
    
• FVC at 6 Hours at Week 6
  • Time Frame: 6 hour
    
• FVC at -10 Minutes at Week 12
  • Time Frame: 10 minutes before dosing
    
• FVC at 15 Minutes at Week 12
  • Time Frame: 15 minutes
    
• FVC at 30 Minutes at Week 12
  • Time Frame: 30 minutes
    
• FVC at 1 Hour at Week 12
  • Time Frame: 1 hour
    
• FVC at 2 Hours at Week 12
  • Time Frame: 2 hour
    
• FVC at 3 Hours at Week 12
  • Time Frame: 3 hour
    
• FVC at 4 Hours at Week 12
  • Time Frame: 4 hour
    
• FVC at 6 Hours at Week 12
  • Time Frame: 6 hour
    
• Day Time Albuterol Use During Week 1
  • Time Frame: Week 1
    
• Day Time Albuterol Use During Week 2
  • Time Frame: Week 2
    
• Day Time Albuterol Use During Week 3
  • Time Frame: Week 3
    
• Day Time Albuterol Use During Week 4
  • Time Frame: Week 4
    
• Day Time Albuterol Use During Week 5
  • Time Frame: Week 5
    
• Day Time Albuterol Use During Week 6
  • Time Frame: Week 6
    
• Day Time Albuterol Use During Week 7
  • Time Frame: Week 7
    
• Day Time Albuterol Use During Week 8
  • Time Frame: Week 8
    
• Day Time Albuterol Use During Week 9
  • Time Frame: Week 9
    
• Day Time Albuterol Use During Week 10
  • Time Frame: Week 10
    
• Day Time Albuterol Use During Week 11
  • Time Frame: Week 11
    
• Day Time Albuterol Use During Week 12
  • Time Frame: Week 12
    
• Night Time Albuterol Use During Week 1
  • Time Frame: Week 1
    
• Night Time Albuterol Use During Week 2
  • Time Frame: Week 2
    
• Night Time Albuterol Use During Week 3
  • Time Frame: Week 3
    
• Night Time Albuterol Use During Week 4
  • Time Frame: Week 4
    
• Night Time Albuterol Use During Week 5
  • Time Frame: Week 5
    
• Night Time Albuterol Use During Week 6
  • Time Frame: Week 6
    
• Night Time Albuterol Use During Week 7
  • Time Frame: Week 7
    
• Night Time Albuterol Use During Week 8
  • Time Frame: Week 8
    
• Night Time Albuterol Use During Week 9
  • Time Frame: Week 9
    
• Night Time Albuterol Use During Week 10
  • Time Frame: Week 10
    
• Night Time Albuterol Use During Week 11
  • Time Frame: Week 11
    
• Night Time Albuterol Use During Week 12
  • Time Frame: Week 12
    
• Morning Peak Expiratory Flow Rate (PEFR) at Week 1
  • Time Frame: Week 1
    
• Morning PEFR at Week 2
  • Time Frame: Week 2
    
• Morning PEFR at Week 3
  • Time Frame: Week 3
    
• Morning PEFR at Week 4
  • Time Frame: Week 4
    
• Morning PEFR at Week 5
  • Time Frame: Week 5
    
• Morning PEFR at Week 6
  • Time Frame: Week 6
    
• Morning PEFR at Week 7
  • Time Frame: Week 7
    
• Morning PEFR at Week 8
  • Time Frame: Week 8
    
• Morning PEFR at Week 9
  • Time Frame: Week 9
    
• Morning PEFR at Week 10
  • Time Frame: Week 10
    
• Morning PEFR at Week 11
  • Time Frame: Week 11
    
• Morning PEFR at Week 12
  • Time Frame: Week 12
    
• Evening PEFR at Week 1
  • Time Frame: Week 1
    
• Evening PEFR at Week 2
  • Time Frame: Week 2
    
• Evening PEFR at Week 3
  • Time Frame: Week 3
    
• Evening PEFR at Week 1
  • Time Frame: Week 4
    
• Evening PEFR at Week 5
  • Time Frame: Week 5
    
• Evening PEFR at Week 6
  • Time Frame: Week 6
    
• Evening PEFR at Week 7
  • Time Frame: Week 7
    
• Evening PEFR at Week 8
  • Time Frame: Week 8
    
• Evening PEFR at Week 9
  • Time Frame: Week 9
    
• Evening PEFR at Week 10
  • Time Frame: Week 10
    
• Evening PEFR at Week 11
  • Time Frame: Week 11
    
• Evening PEFR at Week 12
  • Time Frame: Week 12
    
• Patient Global Evaluation
  • Time Frame: Week 6
    
• Patient Global Evaluation
  • Time Frame: Week 12
    
• Physician Global Evaluation
  • Time Frame: Week 6
    
• Physician Global Evaluation
  • Time Frame: Week 12
    

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00359788

Study ID Number: 205.325

ClinicalTrials.gov Identifier: NCT00359788

Health Authority: United States: Food and Drug Administration