Clinical trial NCT00359788: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 349
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
measure: Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks
timeFrame: Baseline and 6 Weeks
measure: Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
timeFrame: Day 1 (after first dose)
measure: Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6
timeFrame: Baseline and week 6
measure: Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1
timeFrame: Day 1
measure: Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks
timeFrame: Baseline and 12 weeks
measure: Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks
timeFrame: Baseline and 12 Weeks
measure: Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1
timeFrame: Day 1
measure: Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks
timeFrame: Baseline and 6 Weeks
measure: Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1
timeFrame: Day 1
measure: Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6
timeFrame: baseline and 6 Weeks (after first dose)
measure: Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12
timeFrame: Baseline and 12 Weeks
measure: FEV1 at 15 Minutes on Day 1
timeFrame: 15 minutes
measure: FEV1 at 30 Minutes on Day 1
timeFrame: 30 minutes
measure: FEV1 at 1 Hour on Day 1
timeFrame: 1 hour
measure: FEV1 at 2 Hours on Day 1
timeFrame: 2 hour
measure: FEV1 at 3 Hours on Day 1
timeFrame: 3 hour
measure: FEV1 at 4 Hours on Day 1
timeFrame: 4 hour
measure: FEV1 at 6 Hours on Day 1
timeFrame: 6 hours
measure: FEV1 at -10 Minutes at Week 6
timeFrame: 10 minutes before dosing
measure: FEV1 at 15 Minutes at Week 6
timeFrame: 15 minutes
measure: FEV1 at 30 Minutes at Week 6
timeFrame: 30 minutes
measure: FEV1 at 1 Hour at Week 6
timeFrame: 1 hour
measure: FEV1 at 2 Hours at Week 6
timeFrame: 2 hour
measure: FEV1 at 3 Hours at Week 6
timeFrame: 3 hour
measure: FEV1 at 4 Hours at Week 6
timeFrame: 4 hour
measure: FEV1 at 6 Hours at Week 6
timeFrame: 6 hour
measure: FEV1 at -10 Minutes at Week 12
timeFrame: 10 minutes before dosing
measure: FEV1 at 15 Minutes at Week 12
timeFrame: 15 minutes
measure: FEV1 at 30 Minutes at Week 12
timeFrame: 30 minutes
measure: FEV1 at 1 Hour at Week 12
timeFrame: 1 hour
measure: FEV1 at 2 Hours at Week 12
timeFrame: 2 hour
measure: FEV1 at 3 Hours at Week 12
timeFrame: 3 hour
measure: FEV1 at 4 Hours at Week 12
timeFrame: 4 hour
measure: FEV1 at 6 Hours at Week 12
timeFrame: 6 hour
measure: FVC at 15 Minutes on Day 1
timeFrame: 15 minutes
measure: FVC at 30 Minutes on Day 1
timeFrame: 30 minutes
measure: FVC at 1 Hour on Day 1
timeFrame: 1 hour
measure: FVC at 2 Hours on Day 1
timeFrame: 2 hour
measure: FVC at 3 Hours on Day 1
timeFrame: 3 hour
measure: FVC at 4 Hours on Day 1
timeFrame: 4 hour
measure: FVC at 6 Hours on Day 1
timeFrame: 6 hour
measure: FVC at -10 Minutes at Week 6
timeFrame: 10 minutes before dosing
measure: FVC at 15 Minutes at Week 6
timeFrame: 15 minutes
measure: FVC at 30 Minutes at Week 6
timeFrame: 30 minutes
measure: FVC at 1 Hour at Week 6
timeFrame: 1 hour
measure: FVC at 2 Hours at Week 6
timeFrame: 2 hour
measure: FVC at 3 Hours at Week 6
timeFrame: 3 hour
measure: FVC at 4 Hours at Week 6
timeFrame: 4 hour
measure: FVC at 6 Hours at Week 6
timeFrame: 6 hour
measure: FVC at -10 Minutes at Week 12
timeFrame: 10 minutes before dosing
measure: FVC at 15 Minutes at Week 12
timeFrame: 15 minutes
measure: FVC at 30 Minutes at Week 12
timeFrame: 30 minutes
measure: FVC at 1 Hour at Week 12
timeFrame: 1 hour
measure: FVC at 2 Hours at Week 12
timeFrame: 2 hour
measure: FVC at 3 Hours at Week 12
timeFrame: 3 hour
measure: FVC at 4 Hours at Week 12
timeFrame: 4 hour
measure: FVC at 6 Hours at Week 12
timeFrame: 6 hour
measure: Day Time Albuterol Use During Week 1
timeFrame: Week 1
measure: Day Time Albuterol Use During Week 2
timeFrame: Week 2
measure: Day Time Albuterol Use During Week 3
timeFrame: Week 3
measure: Day Time Albuterol Use During Week 4
timeFrame: Week 4
measure: Day Time Albuterol Use During Week 5
timeFrame: Week 5
measure: Day Time Albuterol Use During Week 6
timeFrame: Week 6
measure: Day Time Albuterol Use During Week 7
timeFrame: Week 7
measure: Day Time Albuterol Use During Week 8
timeFrame: Week 8
measure: Day Time Albuterol Use During Week 9
timeFrame: Week 9
measure: Day Time Albuterol Use During Week 10
timeFrame: Week 10
measure: Day Time Albuterol Use During Week 11
timeFrame: Week 11
measure: Day Time Albuterol Use During Week 12
timeFrame: Week 12
measure: Night Time Albuterol Use During Week 1
timeFrame: Week 1
measure: Night Time Albuterol Use During Week 2
timeFrame: Week 2
measure: Night Time Albuterol Use During Week 3
timeFrame: Week 3
measure: Night Time Albuterol Use During Week 4
timeFrame: Week 4
measure: Night Time Albuterol Use During Week 5
timeFrame: Week 5
measure: Night Time Albuterol Use During Week 6
timeFrame: Week 6
measure: Night Time Albuterol Use During Week 7
timeFrame: Week 7
measure: Night Time Albuterol Use During Week 8
timeFrame: Week 8
measure: Night Time Albuterol Use During Week 9
timeFrame: Week 9
measure: Night Time Albuterol Use During Week 10
timeFrame: Week 10
measure: Night Time Albuterol Use During Week 11
timeFrame: Week 11
measure: Night Time Albuterol Use During Week 12
timeFrame: Week 12
measure: Morning Peak Expiratory Flow Rate (PEFR) at Week 1
timeFrame: Week 1
measure: Morning PEFR at Week 2
timeFrame: Week 2
measure: Morning PEFR at Week 3
timeFrame: Week 3
measure: Morning PEFR at Week 4
timeFrame: Week 4
measure: Morning PEFR at Week 5
timeFrame: Week 5
measure: Morning PEFR at Week 6
timeFrame: Week 6
measure: Morning PEFR at Week 7
timeFrame: Week 7
measure: Morning PEFR at Week 8
timeFrame: Week 8
measure: Morning PEFR at Week 9
timeFrame: Week 9
measure: Morning PEFR at Week 10
timeFrame: Week 10
measure: Morning PEFR at Week 11
timeFrame: Week 11
measure: Morning PEFR at Week 12
timeFrame: Week 12
measure: Evening PEFR at Week 1
timeFrame: Week 1
measure: Evening PEFR at Week 2
timeFrame: Week 2
measure: Evening PEFR at Week 3
timeFrame: Week 3
measure: Evening PEFR at Week 4
timeFrame: Week 4
measure: Evening PEFR at Week 5
timeFrame: Week 5
measure: Evening PEFR at Week 6
timeFrame: Week 6
measure: Evening PEFR at Week 7
timeFrame: Week 7
measure: Evening PEFR at Week 8
timeFrame: Week 8
measure: Evening PEFR at Week 9
timeFrame: Week 9
measure: Evening PEFR at Week 10
timeFrame: Week 10
measure: Evening PEFR at Week 11
timeFrame: Week 11
measure: Evening PEFR at Week 12
timeFrame: Week 12
measure: Patient Global Evaluation
timeFrame: Week 6
measure: Patient Global Evaluation
timeFrame: Week 12
measure: Physician Global Evaluation
timeFrame: Week 6
measure: Physician Global Evaluation
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 205.325.904 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 205.325.925 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: 205.325.909 Boehringer Ingelheim Investigational Site
state: Arizona
city: Long Beach
country: United States
facility: 205.325.912 Boehringer Ingelheim Investigational Site
state: California
city: Palo Alto
country: United States
facility: 205.325.911 Boehringer Ingelheim Investigational Site
state: California
city: Fort Collins
country: United States
facility: 205.325.935 Boehringer Ingelheim Investigational Site
state: Colorado
city: West Haven
country: United States
facility: 205.325.903 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Bay Pines
country: United States
facility: 205.325.905 Boehringer Ingelheim Investigational Site
state: Florida
city: Decatur
country: United States
facility: 205.325.922 Boehringer Ingelheim Investigational Site
state: Georgia
city: North Chicago
country: United States
facility: 205.325.907 Boehringer Ingelheim Investigational Site
state: Illinois
city: Indiananapolis
country: United States
facility: 205.325.928 Boehringer Ingelheim Investigational Site
state: Indiana
city: Wichita
country: United States
facility: 205.325.923 Boehringer Ingelheim Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: 205.325.902 Boehringer Ingelheim Investigational Site
state: Maryland
city: Boston
country: United States
facility: 205.325.908 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: 205.325.920 Boehringer Ingelheim Investigational Site
state: Michigan
city: Ann Arbor
country: United States
facility: 205.325.932 Boehringer Ingelheim Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: 205.325.915 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: 205.325.914 Boehringer Ingelheim Investigational Site
state: Missouri
city: Reno
country: United States
facility: 205.325.910 Boehringer Ingelheim Investigational Site
state: Nevada
city: East Orange
country: United States
facility: 205.325.924 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: 205.325.921 Boehringer Ingelheim Investigational Site
state: New York
city: Buffalo
country: United States
facility: 205.325.917 Boehringer Ingelheim Investigational Site
state: New York
city: Cincinnati
country: United States
facility: 205.325.926 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: 205.325.901 Boehringer Ingelheim Investigational Site
state: Ohio
city: Portland
country: United States
facility: 205.325.931 Boehringer Ingelheim Investigational Site
state: Oregon
city: Providence
country: United States
facility: 205.325.929 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Greenville
country: United States
facility: 205.325.936 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Houston
country: United States
facility: 205.325.918 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 205.325.927 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 205.325.919 Boehringer Ingelheim Investigational Site
state: Utah
city: Richmond
country: United States
facility: 205.325.906 Boehringer Ingelheim Investigational Site
state: Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: