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

NCT00359788 | Completed Phase 4 Results

• 1 other identifier: 205.325
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 31

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (112)

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

  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

  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

  Baseline and week 6

• Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1

  Day 1

• Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6

  Baseline and 6 weeks

Interventions

tiotropium DRUG

Combivent (Ipratropium/Albuterol) DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (31)

205.325.904 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

205.325.925 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

205.325.909 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

205.325.912 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

205.325.911 Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Location

205.325.935 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Location

205.325.903 Boehringer Ingelheim Investigational Site

West Haven, Connecticut, United States

Location

205.325.905 Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

Location

205.325.922 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

205.325.907 Boehringer Ingelheim Investigational Site

North Chicago, Illinois, United States

Location

205.325.928 Boehringer Ingelheim Investigational Site

Indiananapolis, Indiana, United States

Location

205.325.923 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

205.325.902 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

205.325.908 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

205.325.920 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

205.325.932 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

205.325.915 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Location

205.325.914 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

205.325.910 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Location

205.325.924 Boehringer Ingelheim Investigational Site

East Orange, New Jersey, United States

Location

205.325.921 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Location

205.325.917 Boehringer Ingelheim Investigational Site

Buffalo, New York, United States

Location

205.325.926 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

205.325.901 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Location

205.325.931 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

205.325.929 Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

Location

205.325.936 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

205.325.918 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

205.325.927 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

205.325.919 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

205.325.906 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Albuterol, Ipratropium Drug Combination; Ipratropium; Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines; Atropine Derivatives; Belladonna Alkaloids; Solanaceous Alkaloids; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 2, 2006
• Study Start: July 1, 2006
• Primary Completion: April 1, 2008
• Last Updated: May 16, 2014
• Results First Posted: November 10, 2009

Record last verified: 2013-09

Locations

US (31)