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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: tiotropium; Drug: Combivent (Ipratropium/Albuterol)

• Study Type: Interventional
• Enrollment (Actual): 349
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • 205.325.904 Boehringer Ingelheim Investigational Site
  • Arizona
    • Phoenix, Arizona, United States
      • 205.325.925 Boehringer Ingelheim Investigational Site
    • Tucson, Arizona, United States
      • 205.325.909 Boehringer Ingelheim Investigational Site
  • California
    • Long Beach, California, United States
      • 205.325.912 Boehringer Ingelheim Investigational Site
    • Palo Alto, California, United States
      • 205.325.911 Boehringer Ingelheim Investigational Site
  • Colorado
    • Fort Collins, Colorado, United States
      • 205.325.935 Boehringer Ingelheim Investigational Site
  • Connecticut
    • West Haven, Connecticut, United States
      • 205.325.903 Boehringer Ingelheim Investigational Site
  • Florida
    • Bay Pines, Florida, United States
      • 205.325.905 Boehringer Ingelheim Investigational Site
  • Georgia
    • Decatur, Georgia, United States
      • 205.325.922 Boehringer Ingelheim Investigational Site
  • Illinois
    • North Chicago, Illinois, United States
      • 205.325.907 Boehringer Ingelheim Investigational Site
  • Indiana
    • Indiananapolis, Indiana, United States
      • 205.325.928 Boehringer Ingelheim Investigational Site
  • Kansas
    • Wichita, Kansas, United States
      • 205.325.923 Boehringer Ingelheim Investigational Site
  • Maryland
    • Baltimore, Maryland, United States
      • 205.325.902 Boehringer Ingelheim Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States
      • 205.325.908 Boehringer Ingelheim Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States
      • 205.325.920 Boehringer Ingelheim Investigational Site
    • Ann Arbor, Michigan, United States
      • 205.325.932 Boehringer Ingelheim Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States
      • 205.325.915 Boehringer Ingelheim Investigational Site
  • Missouri
    • Kansas City, Missouri, United States
      • 205.325.914 Boehringer Ingelheim Investigational Site
  • Nevada
    • Reno, Nevada, United States
      • 205.325.910 Boehringer Ingelheim Investigational Site
  • New Jersey
    • East Orange, New Jersey, United States
      • 205.325.924 Boehringer Ingelheim Investigational Site
  • New York
    • Brooklyn, New York, United States
      • 205.325.921 Boehringer Ingelheim Investigational Site
    • Buffalo, New York, United States
      • 205.325.917 Boehringer Ingelheim Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States
      • 205.325.926 Boehringer Ingelheim Investigational Site
    • Cleveland, Ohio, United States
      • 205.325.901 Boehringer Ingelheim Investigational Site
  • Oregon
    • Portland, Oregon, United States
      • 205.325.931 Boehringer Ingelheim Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States
      • 205.325.929 Boehringer Ingelheim Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States
      • 205.325.936 Boehringer Ingelheim Investigational Site
  • Texas
    • Houston, Texas, United States
      • 205.325.918 Boehringer Ingelheim Investigational Site
    • San Antonio, Texas, United States
      • 205.325.927 Boehringer Ingelheim Investigational Site
  • Utah
    • Salt Lake City, Utah, United States
      • 205.325.919 Boehringer Ingelheim Investigational Site
  • Virginia
    • Richmond, Virginia, United States
      • 205.325.906 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks	Trough FEV1 is measured 10 minutes before drug administration	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	Average hourly FEV1 AUC0-6 minus baseline FEV1	Baseline and 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks	Trough FEV1 is measured 10 minutes before drug administration	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	Average hourly FEV1 AUC0-6 minus baseline FEV1	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	Average hourly FEV1 AUC0-6 minus baseline FEV1	Baseline and week 6
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1	Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication	Day 1
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6	Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication	Baseline and 6 weeks
Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12	Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication	Baseline and 12 weeks
Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks	Trough FVC is measured 10 minutes before drug administration	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	Average hourly FVC AUC0-6 minus baseline FVC	Baseline and 12 Weeks
Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks	Trough FVC is measured 10 minutes before drug administration	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	Average hourly FVC AUC0-6 minus baseline FVC	Day 1
Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks	Average hourly FVC AUC0-6 minus baseline FVC	Baseline and 6 Weeks
Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1	Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication	Day 1
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6	Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication	baseline and 6 Weeks (after first dose)
Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12	Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication	Baseline and 12 Weeks
FEV1 at 15 Minutes on Day 1		15 minutes
FEV1 at 30 Minutes on Day 1		30 minutes
FEV1 at 1 Hour on Day 1		1 hour
FEV1 at 2 Hours on Day 1		2 hour
FEV1 at 3 Hours on Day 1		3 hour
FEV1 at 4 Hours on Day 1		4 hour
FEV1 at 6 Hours on Day 1		6 hours
FEV1 at -10 Minutes at Week 6		10 minutes before dosing
FEV1 at 15 Minutes at Week 6		15 minutes
FEV1 at 30 Minutes at Week 6		30 minutes
FEV1 at 1 Hour at Week 6		1 hour
FEV1 at 2 Hours at Week 6		2 hour
FEV1 at 3 Hours at Week 6		3 hour
FEV1 at 4 Hours at Week 6		4 hour
FEV1 at 6 Hours at Week 6		6 hour
FEV1 at -10 Minutes at Week 12		10 minutes before dosing
FEV1 at 15 Minutes at Week 12		15 minutes
FEV1 at 30 Minutes at Week 12		30 minutes
FEV1 at 1 Hour at Week 12		1 hour
FEV1 at 2 Hours at Week 12		2 hour
FEV1 at 3 Hours at Week 12		3 hour
FEV1 at 4 Hours at Week 12		4 hour
FEV1 at 6 Hours at Week 12		6 hour
FVC at 15 Minutes on Day 1		15 minutes
FVC at 30 Minutes on Day 1		30 minutes
FVC at 1 Hour on Day 1		1 hour
FVC at 2 Hours on Day 1		2 hour
FVC at 3 Hours on Day 1		3 hour
FVC at 4 Hours on Day 1		4 hour
FVC at 6 Hours on Day 1		6 hour
FVC at -10 Minutes at Week 6		10 minutes before dosing
FVC at 15 Minutes at Week 6		15 minutes
FVC at 30 Minutes at Week 6		30 minutes
FVC at 1 Hour at Week 6		1 hour
FVC at 2 Hours at Week 6		2 hour
FVC at 3 Hours at Week 6		3 hour
FVC at 4 Hours at Week 6		4 hour
FVC at 6 Hours at Week 6		6 hour
FVC at -10 Minutes at Week 12		10 minutes before dosing
FVC at 15 Minutes at Week 12		15 minutes
FVC at 30 Minutes at Week 12		30 minutes
FVC at 1 Hour at Week 12		1 hour
FVC at 2 Hours at Week 12		2 hour
FVC at 3 Hours at Week 12		3 hour
FVC at 4 Hours at Week 12		4 hour
FVC at 6 Hours at Week 12		6 hour
Day Time Albuterol Use During Week 1	Puffs of rescue albuterol used during the day in week 1	Week 1
Day Time Albuterol Use During Week 2	Puffs of rescue albuterol used during the day in week 2	Week 2
Day Time Albuterol Use During Week 3	Puffs of rescue albuterol used during the day in week 3	Week 3
Day Time Albuterol Use During Week 4	Puffs of rescue albuterol used during the day in week 4	Week 4
Day Time Albuterol Use During Week 5	Puffs of rescue albuterol used during the day in week 5	Week 5
Day Time Albuterol Use During Week 6	Puffs of rescue albuterol used during the day in week 6	Week 6
Day Time Albuterol Use During Week 7	Puffs of rescue albuterol used during the day in week 7	Week 7
Day Time Albuterol Use During Week 8	Puffs of rescue albuterol used during the day in week 8	Week 8
Day Time Albuterol Use During Week 9	Puffs of rescue albuterol used during the day in week 9	Week 9
Day Time Albuterol Use During Week 10	Puffs of rescue albuterol used during the day in week 10	Week 10
Day Time Albuterol Use During Week 11	Puffs of rescue albuterol used during the day in week 11	Week 11
Day Time Albuterol Use During Week 12	Puffs of rescue albuterol used during the day in week 12	Week 12
Night Time Albuterol Use During Week 1		Week 1
Night Time Albuterol Use During Week 2	Puffs of rescue albuterol used during the night in week 2	Week 2
Night Time Albuterol Use During Week 3	Puffs of rescue albuterol used during the night in week 3	Week 3
Night Time Albuterol Use During Week 4	Puffs of rescue albuterol used during the night in week 4	Week 4
Night Time Albuterol Use During Week 5	Puffs of rescue albuterol used during the night in week 5	Week 5
Night Time Albuterol Use During Week 6	Puffs of rescue albuterol used during the night in week 6	Week 6
Night Time Albuterol Use During Week 7	Puffs of rescue albuterol used during the night in week 7	Week 7
Night Time Albuterol Use During Week 8	Puffs of rescue albuterol used during the night in week 8	Week 8
Night Time Albuterol Use During Week 9	Puffs of rescue albuterol used during the night in week 9	Week 9
Night Time Albuterol Use During Week 10	Puffs of rescue albuterol used during the night in week 10	Week 10
Night Time Albuterol Use During Week 11	Puffs of rescue albuterol used during the night in week 11	Week 11
Night Time Albuterol Use During Week 12	Puffs of rescue albuterol used during the night in week 12	Week 12
Morning Peak Expiratory Flow Rate (PEFR) at Week 1		Week 1
Morning PEFR at Week 2	Weekly means for morning PEFR	Week 2
Morning PEFR at Week 3	Weekly means for morning PEFR	Week 3
Morning PEFR at Week 4	Weekly means for morning PEFR	Week 4
Morning PEFR at Week 5	Weekly means for morning PEFR	Week 5
Morning PEFR at Week 6	Weekly means for morning PEFR	Week 6
Morning PEFR at Week 7	Weekly means for morning PEFR	Week 7
Morning PEFR at Week 8	Weekly means for morning PEFR	Week 8
Morning PEFR at Week 9	Weekly means for morning PEFR	Week 9
Morning PEFR at Week 10	Weekly means for morning PEFR	Week 10
Morning PEFR at Week 11	Weekly means for morning PEFR	Week 11
Morning PEFR at Week 12	Weekly means for morning PEFR	Week 12
Evening PEFR at Week 1	Weekly means for evening PEFR	Week 1
Evening PEFR at Week 2	Weekly means for evening PEFR	Week 2
Evening PEFR at Week 3	Weekly means for evening PEFR	Week 3
Evening PEFR at Week 4	Weekly means for evening PEFR	Week 4
Evening PEFR at Week 5	Weekly means for evening PEFR	Week 5
Evening PEFR at Week 6	Weekly means for evening PEFR	Week 6
Evening PEFR at Week 7	Weekly means for evening PEFR	Week 7
Evening PEFR at Week 8	Weekly means for evening PEFR	Week 8
Evening PEFR at Week 9	Weekly means for evening PEFR	Week 9
Evening PEFR at Week 10	Weekly means for evening PEFR	Week 10
Evening PEFR at Week 11	Weekly means for evening PEFR	Week 11
Evening PEFR at Week 12	Weekly means for evening PEFR	Week 12
Patient Global Evaluation	The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)	Week 6
Patient Global Evaluation	The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).	Week 12
Physician Global Evaluation	The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).	Week 6
Physician Global Evaluation	The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).	Week 12

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: August 1, 2006
• First Submitted That Met QC Criteria: August 1, 2006
• First Posted (Estimate): August 2, 2006

Study Record Updates

• Last Update Posted (Estimate): May 16, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Tiotropium Bromide; Ipratropium
• Other Study ID Numbers: 205.325