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

Boehringer Ingelheim349 enrolled

Overview

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

349

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropiumDRUG

Combivent (Ipratropium/Albuterol)DRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (31)

Outcomes

Primary Outcomes

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks

Trough FEV1 is measured 10 minutes before drug administration

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

Average hourly FEV1 AUC0-6 minus baseline FEV1

Time frame: Baseline and 12 Weeks

Secondary Outcomes

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks

Trough FEV1 is measured 10 minutes before drug administration

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

Average hourly FEV1 AUC0-6 minus baseline FEV1

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

Average hourly FEV1 AUC0-6 minus baseline FEV1

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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205.325.904 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

205.325.925 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

205.325.909 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

205.325.912 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

205.325.911 Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

205.325.935 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

205.325.903 Boehringer Ingelheim Investigational Site

West Haven, Connecticut, United States

205.325.905 Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

205.325.922 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

205.325.907 Boehringer Ingelheim Investigational Site

North Chicago, Illinois, United States

...and 21 more locations

Time frame: 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

Time frame: 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

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

Average hourly FVC AUC0-6 minus baseline FVC

Time frame: 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

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

Average hourly FVC AUC0-6 minus baseline FVC

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

Average hourly FVC AUC0-6 minus baseline FVC

Time frame: 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

Time frame: 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

Time frame: 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

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

Puffs of rescue albuterol used during the day in week 1

Time frame: Week 1

Day Time Albuterol Use During Week 2

Puffs of rescue albuterol used during the day in week 2

Time frame: Week 2

Day Time Albuterol Use During Week 3

Puffs of rescue albuterol used during the day in week 3

Time frame: Week 3

Day Time Albuterol Use During Week 4

Puffs of rescue albuterol used during the day in week 4

Time frame: Week 4

Day Time Albuterol Use During Week 5

Puffs of rescue albuterol used during the day in week 5

Time frame: Week 5

Day Time Albuterol Use During Week 6

Puffs of rescue albuterol used during the day in week 6

Time frame: Week 6

Day Time Albuterol Use During Week 7

Puffs of rescue albuterol used during the day in week 7

Time frame: Week 7

Day Time Albuterol Use During Week 8

Puffs of rescue albuterol used during the day in week 8

Time frame: Week 8

Day Time Albuterol Use During Week 9

Puffs of rescue albuterol used during the day in week 9

Time frame: Week 9

Day Time Albuterol Use During Week 10

Puffs of rescue albuterol used during the day in week 10

Time frame: Week 10

Day Time Albuterol Use During Week 11

Puffs of rescue albuterol used during the day in week 11

Time frame: Week 11

Day Time Albuterol Use During Week 12

Puffs of rescue albuterol used during the day in week 12

Time frame: Week 12

Night Time Albuterol Use During Week 1

Time frame: Week 1

Night Time Albuterol Use During Week 2

Puffs of rescue albuterol used during the night in week 2

Time frame: Week 2

Night Time Albuterol Use During Week 3

Puffs of rescue albuterol used during the night in week 3

Time frame: Week 3

Night Time Albuterol Use During Week 4

Puffs of rescue albuterol used during the night in week 4

Time frame: Week 4

Night Time Albuterol Use During Week 5

Puffs of rescue albuterol used during the night in week 5

Time frame: Week 5

Night Time Albuterol Use During Week 6

Puffs of rescue albuterol used during the night in week 6

Time frame: Week 6

Night Time Albuterol Use During Week 7

Puffs of rescue albuterol used during the night in week 7

Time frame: Week 7

Night Time Albuterol Use During Week 8

Puffs of rescue albuterol used during the night in week 8

Time frame: Week 8

Night Time Albuterol Use During Week 9

Puffs of rescue albuterol used during the night in week 9

Time frame: Week 9

Night Time Albuterol Use During Week 10

Puffs of rescue albuterol used during the night in week 10

Time frame: Week 10

Night Time Albuterol Use During Week 11

Puffs of rescue albuterol used during the night in week 11

Time frame: Week 11

Night Time Albuterol Use During Week 12

Puffs of rescue albuterol used during the night in week 12

Time frame: Week 12

Morning Peak Expiratory Flow Rate (PEFR) at Week 1

Time frame: Week 1

Morning PEFR at Week 2

Weekly means for morning PEFR

Time frame: Week 2

Morning PEFR at Week 3

Weekly means for morning PEFR

Time frame: Week 3

Morning PEFR at Week 4

Weekly means for morning PEFR

Time frame: Week 4

Morning PEFR at Week 5

Weekly means for morning PEFR

Time frame: Week 5

Morning PEFR at Week 6

Weekly means for morning PEFR

Time frame: Week 6

Morning PEFR at Week 7

Weekly means for morning PEFR

Time frame: Week 7

Morning PEFR at Week 8

Weekly means for morning PEFR

Time frame: Week 8

Morning PEFR at Week 9

Weekly means for morning PEFR

Time frame: Week 9

Morning PEFR at Week 10

Weekly means for morning PEFR

Time frame: Week 10

Morning PEFR at Week 11

Weekly means for morning PEFR

Time frame: Week 11

Morning PEFR at Week 12

Weekly means for morning PEFR

Time frame: Week 12

Evening PEFR at Week 1

Weekly means for evening PEFR

Time frame: Week 1

Evening PEFR at Week 2

Weekly means for evening PEFR

Time frame: Week 2

Evening PEFR at Week 3

Weekly means for evening PEFR

Time frame: Week 3

Evening PEFR at Week 4

Weekly means for evening PEFR

Time frame: Week 4

Evening PEFR at Week 5

Weekly means for evening PEFR

Time frame: Week 5

Evening PEFR at Week 6

Weekly means for evening PEFR

Time frame: Week 6

Evening PEFR at Week 7

Weekly means for evening PEFR

Time frame: Week 7

Evening PEFR at Week 8

Weekly means for evening PEFR

Time frame: Week 8

Evening PEFR at Week 9

Weekly means for evening PEFR

Time frame: Week 9

Evening PEFR at Week 10

Weekly means for evening PEFR

Time frame: Week 10

Evening PEFR at Week 11

Weekly means for evening PEFR

Time frame: Week 11

Evening PEFR at Week 12

Weekly means for evening PEFR

Time frame: 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)

Time frame: 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).

Time frame: 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).

Time frame: Week 6

Physician Global Evaluation

Time frame: Week 12