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

This study has been completed.

First Received: August 1, 2006 Last Updated: November 7, 2008 History of Changes

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00359788

Purpose

The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler 18 mcg daily compared to Combivent MDI CFC Inhalation Aerosol 2 actuations qid COPD patients currently prescribed Combivent® MDI.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: tiotropium Drug: ipratropium bromide / albuterol	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Albuterol Ipratropium bromide Ipratropium Tiotropium bromide Tiotropium Combivent

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Trough and AUC0-6 FEV1 after 12 weeks. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Peak FEV1, FVC (trough, peak, AUC0-6), FEV1 and FVC at each timepoint, trough FEV1 at 6 weeks, albuterol use, Patient and Physician Global Evaluations, daily PEFR [ Time Frame: 6 weeks and 12 weeks ]

Enrollment:	349
Study Start Date:	July 2006
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inclusion Criteria: Diagnosis of COPD Age: greater than or equal to 40 years

Current or ex-smoker with a >= 10 pack-year smoking history
Use of Combivent® MDI for >= 1 month prior to Visit 1

Spirometric criteria (determined at study visits):

Post-bronchodilator FEV1 <= 70% (Visit 1)
Pre-bronchodilator FEV1 <= 65% of predicted and FEV1/FVC <= 70% (Visit 2)

Exclusion Criteria:

Clinical history of asthma

History of thoracotomy with pulmonary resection
History of CF, 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 PFTs
Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
Recent history 6 months or less of MI
Unstable or life-threatening cardiac arrhythmias
Hospitalization for CHF 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359788

Show 31 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	205.325
Study First Received:	August 1, 2006
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00359788 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Albuterol
Anti-Asthmatic Agents
Cholinergic Agents
Lung Diseases, Obstructive
Respiratory Tract Diseases
Ipratropium

Bromides
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Pathologic Processes
Respiratory Tract Diseases
Ipratropium
Autonomic Agents
Therapeutic Uses
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on July 02, 2009