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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359788
• Other study ID #: 205.325
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2006
• Last updated: May 7, 2014
• Start date: July 2006

Study information

• Verified date: September 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• tiotropium

• Combivent (Ipratropium/Albuterol)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	FEV1 at 15 Minutes on Day 1		15 minutes
Secondary	FEV1 at 30 Minutes on Day 1		30 minutes
Secondary	FEV1 at 1 Hour on Day 1		1 hour
Secondary	FEV1 at 2 Hours on Day 1		2 hour
Secondary	FEV1 at 3 Hours on Day 1		3 hour
Secondary	FEV1 at 4 Hours on Day 1		4 hour
Secondary	FEV1 at 6 Hours on Day 1		6 hours
Secondary	FEV1 at -10 Minutes at Week 6		10 minutes before dosing
Secondary	FEV1 at 15 Minutes at Week 6		15 minutes
Secondary	FEV1 at 30 Minutes at Week 6		30 minutes
Secondary	FEV1 at 1 Hour at Week 6		1 hour
Secondary	FEV1 at 2 Hours at Week 6		2 hour
Secondary	FEV1 at 3 Hours at Week 6		3 hour
Secondary	FEV1 at 4 Hours at Week 6		4 hour
Secondary	FEV1 at 6 Hours at Week 6		6 hour
Secondary	FEV1 at -10 Minutes at Week 12		10 minutes before dosing
Secondary	FEV1 at 15 Minutes at Week 12		15 minutes
Secondary	FEV1 at 30 Minutes at Week 12		30 minutes
Secondary	FEV1 at 1 Hour at Week 12		1 hour
Secondary	FEV1 at 2 Hours at Week 12		2 hour
Secondary	FEV1 at 3 Hours at Week 12		3 hour
Secondary	FEV1 at 4 Hours at Week 12		4 hour
Secondary	FEV1 at 6 Hours at Week 12		6 hour
Secondary	FVC at 15 Minutes on Day 1		15 minutes
Secondary	FVC at 30 Minutes on Day 1		30 minutes
Secondary	FVC at 1 Hour on Day 1		1 hour
Secondary	FVC at 2 Hours on Day 1		2 hour
Secondary	FVC at 3 Hours on Day 1		3 hour
Secondary	FVC at 4 Hours on Day 1		4 hour
Secondary	FVC at 6 Hours on Day 1		6 hour
Secondary	FVC at -10 Minutes at Week 6		10 minutes before dosing
Secondary	FVC at 15 Minutes at Week 6		15 minutes
Secondary	FVC at 30 Minutes at Week 6		30 minutes
Secondary	FVC at 1 Hour at Week 6		1 hour
Secondary	FVC at 2 Hours at Week 6		2 hour
Secondary	FVC at 3 Hours at Week 6		3 hour
Secondary	FVC at 4 Hours at Week 6		4 hour
Secondary	FVC at 6 Hours at Week 6		6 hour
Secondary	FVC at -10 Minutes at Week 12		10 minutes before dosing
Secondary	FVC at 15 Minutes at Week 12		15 minutes
Secondary	FVC at 30 Minutes at Week 12		30 minutes
Secondary	FVC at 1 Hour at Week 12		1 hour
Secondary	FVC at 2 Hours at Week 12		2 hour
Secondary	FVC at 3 Hours at Week 12		3 hour
Secondary	FVC at 4 Hours at Week 12		4 hour
Secondary	FVC at 6 Hours at Week 12		6 hour
Secondary	Day Time Albuterol Use During Week 1	Puffs of rescue albuterol used during the day in week 1	Week 1
Secondary	Day Time Albuterol Use During Week 2	Puffs of rescue albuterol used during the day in week 2	Week 2
Secondary	Day Time Albuterol Use During Week 3	Puffs of rescue albuterol used during the day in week 3	Week 3
Secondary	Day Time Albuterol Use During Week 4	Puffs of rescue albuterol used during the day in week 4	Week 4
Secondary	Day Time Albuterol Use During Week 5	Puffs of rescue albuterol used during the day in week 5	Week 5
Secondary	Day Time Albuterol Use During Week 6	Puffs of rescue albuterol used during the day in week 6	Week 6
Secondary	Day Time Albuterol Use During Week 7	Puffs of rescue albuterol used during the day in week 7	Week 7
Secondary	Day Time Albuterol Use During Week 8	Puffs of rescue albuterol used during the day in week 8	Week 8
Secondary	Day Time Albuterol Use During Week 9	Puffs of rescue albuterol used during the day in week 9	Week 9
Secondary	Day Time Albuterol Use During Week 10	Puffs of rescue albuterol used during the day in week 10	Week 10
Secondary	Day Time Albuterol Use During Week 11	Puffs of rescue albuterol used during the day in week 11	Week 11
Secondary	Day Time Albuterol Use During Week 12	Puffs of rescue albuterol used during the day in week 12	Week 12
Secondary	Night Time Albuterol Use During Week 1		Week 1
Secondary	Night Time Albuterol Use During Week 2	Puffs of rescue albuterol used during the night in week 2	Week 2
Secondary	Night Time Albuterol Use During Week 3	Puffs of rescue albuterol used during the night in week 3	Week 3
Secondary	Night Time Albuterol Use During Week 4	Puffs of rescue albuterol used during the night in week 4	Week 4
Secondary	Night Time Albuterol Use During Week 5	Puffs of rescue albuterol used during the night in week 5	Week 5
Secondary	Night Time Albuterol Use During Week 6	Puffs of rescue albuterol used during the night in week 6	Week 6
Secondary	Night Time Albuterol Use During Week 7	Puffs of rescue albuterol used during the night in week 7	Week 7
Secondary	Night Time Albuterol Use During Week 8	Puffs of rescue albuterol used during the night in week 8	Week 8
Secondary	Night Time Albuterol Use During Week 9	Puffs of rescue albuterol used during the night in week 9	Week 9
Secondary	Night Time Albuterol Use During Week 10	Puffs of rescue albuterol used during the night in week 10	Week 10
Secondary	Night Time Albuterol Use During Week 11	Puffs of rescue albuterol used during the night in week 11	Week 11
Secondary	Night Time Albuterol Use During Week 12	Puffs of rescue albuterol used during the night in week 12	Week 12
Secondary	Morning Peak Expiratory Flow Rate (PEFR) at Week 1		Week 1
Secondary	Morning PEFR at Week 2	Weekly means for morning PEFR	Week 2
Secondary	Morning PEFR at Week 3	Weekly means for morning PEFR	Week 3
Secondary	Morning PEFR at Week 4	Weekly means for morning PEFR	Week 4
Secondary	Morning PEFR at Week 5	Weekly means for morning PEFR	Week 5
Secondary	Morning PEFR at Week 6	Weekly means for morning PEFR	Week 6
Secondary	Morning PEFR at Week 7	Weekly means for morning PEFR	Week 7
Secondary	Morning PEFR at Week 8	Weekly means for morning PEFR	Week 8
Secondary	Morning PEFR at Week 9	Weekly means for morning PEFR	Week 9
Secondary	Morning PEFR at Week 10	Weekly means for morning PEFR	Week 10
Secondary	Morning PEFR at Week 11	Weekly means for morning PEFR	Week 11
Secondary	Morning PEFR at Week 12	Weekly means for morning PEFR	Week 12
Secondary	Evening PEFR at Week 1	Weekly means for evening PEFR	Week 1
Secondary	Evening PEFR at Week 2	Weekly means for evening PEFR	Week 2
Secondary	Evening PEFR at Week 3	Weekly means for evening PEFR	Week 3
Secondary	Evening PEFR at Week 4	Weekly means for evening PEFR	Week 4
Secondary	Evening PEFR at Week 5	Weekly means for evening PEFR	Week 5
Secondary	Evening PEFR at Week 6	Weekly means for evening PEFR	Week 6
Secondary	Evening PEFR at Week 7	Weekly means for evening PEFR	Week 7
Secondary	Evening PEFR at Week 8	Weekly means for evening PEFR	Week 8
Secondary	Evening PEFR at Week 9	Weekly means for evening PEFR	Week 9
Secondary	Evening PEFR at Week 10	Weekly means for evening PEFR	Week 10
Secondary	Evening PEFR at Week 11	Weekly means for evening PEFR	Week 11
Secondary	Evening PEFR at Week 12	Weekly means for evening PEFR	Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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