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

NCT ID: NCT00359788

Last Updated: 2014-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

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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.

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

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A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)

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Pulmonary Disease, Chronic Obstructive
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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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tiotropium

Intervention Type DRUG

Combivent (Ipratropium/Albuterol)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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205.325.904 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

205.325.925 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

205.325.909 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Site Status

205.325.912 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Site Status

205.325.911 Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Site Status

205.325.935 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Site Status

205.325.903 Boehringer Ingelheim Investigational Site

West Haven, Connecticut, United States

Site Status

205.325.905 Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

Site Status

205.325.922 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Site Status

205.325.907 Boehringer Ingelheim Investigational Site

North Chicago, Illinois, United States

Site Status

205.325.928 Boehringer Ingelheim Investigational Site

Indiananapolis, Indiana, United States

Site Status

205.325.923 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Site Status

205.325.902 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

205.325.908 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

205.325.920 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Site Status

205.325.932 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Site Status

205.325.915 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Site Status

205.325.914 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Site Status

205.325.910 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Site Status

205.325.924 Boehringer Ingelheim Investigational Site

East Orange, New Jersey, United States

Site Status

205.325.921 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Site Status

205.325.917 Boehringer Ingelheim Investigational Site

Buffalo, New York, United States

Site Status

205.325.926 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

205.325.901 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Site Status

205.325.931 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

205.325.929 Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

Site Status

205.325.936 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

205.325.918 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

205.325.927 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

205.325.919 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Site Status

205.325.906 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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205.325

Identifier Type: -

Identifier Source: org_study_id

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