Effect of Brovana and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsors and Collaborators:	Saint Francis Care Sepracor, Inc.
Information provided by:	Saint Francis Care
ClinicalTrials.gov Identifier:	NCT00773786

Purpose

This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this study will provide proof-of-concept information on whether the (anticipated) additional bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in the patient-centered outcome, exercise capacity. This study will only evaluate the effects of short-term (1-week) administration of Brovana. If results are positive, it would provide preliminary data for further, multicenter investigations.

Condition	Intervention	Phase
COPD	Drug: arformoterol (Brovana)	Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness

Drug Information available for: Tiotropium Tiotropium bromide Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Double-Blind, Crossover Study to Assess the Effects of Nebulized Brovana Added to Tiotropium on FEV1, Hyperinflation, and Exercise Endurance Capacity in COPD

Further study details as provided by Saint Francis Care:

Primary Outcome Measures:

Exercise endurance capacity on treadmill [ Time Frame: 2 1/4 hours after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

FEV1 [ Time Frame: 2 hours after dosing ] [ Designated as safety issue: No ]
Inspiratory capacity [ Time Frame: 2 hours after dosing ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

twice daily via nebulizer added to maintenance daily tiotropium

Show Detailed Description

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed consent (Approval by the St. Francis Hospital IRB will be required before study initiation)
Adults, age > 40 years
A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator FEV1/FVC < 0.70
Moderate, severe and very severe airflow limitation by GOLD criteria.
Clinically stable respiratory disease
The perceived ability to participate in pulmonary testing and exercise testing
COPD, stable state

Exclusion criteria:

Women of childbearing potential
Asthma
Supplemental oxygen use or anticipated oxygen desaturation < 85% at peak exercise (patients who desaturate below 85% on the incremental study will be excluded)
Co-morbidity that would interfere with the patient participating in the study, including the exercise testing. Examples include unstable cardiac disease, arthritis, psychological problems that would interfere with participation
An exacerbation requiring therapy or any change in maintenance COPD therapy within six weeks of testing
A history of a prolonged QT interval
Recent exacerbation of COPD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773786

Locations

United States, Connecticut
St Francis Hospital and Medical center	Recruiting
Hartford, Connecticut, United States, 06105
Contact: Richard L Zuwallack, MD 860-714-4045 rzuwalla@stfranciscare.org
Contact: Binusha Moitheennazima, MBBS 860 714 4045 binusha@haafiz.org
Principal Investigator: Richard L Zuwallack, MD

Sponsors and Collaborators

Saint Francis Care

Sepracor, Inc.

More Information

Responsible Party:	Section of Pulmonary and Critical Care, St. Francis Hospital, Hartford, CT 06105 ( Richard ZuWallack, MD (Principal Investigator) )
Study ID Numbers:	ASRC956
Study First Received:	October 14, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00773786
Health Authority:	United States: Institutional Review Board

Keywords provided by Saint Francis Care:

COPD
Bronchodilator
arformoterol
tiotropium

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Formoterol
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Anti-Asthmatic Agents
Cholinergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009