Effect of Brovana and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT00773786
First received: October 14, 2008
Last updated: July 17, 2012
Last verified: July 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 20
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arformoterol
Arformoterol twice daily for 1 week via nebulizer
Drug: Arformoterol (Brovana)
twice daily via nebulizer added to maintenance daily tiotropium
Placebo Comparator: Placebo
Placebo twice daily for 1 week

  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:

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

Exclusion criteria:

  1. Women of childbearing potential
  2. Asthma
  3. Supplemental oxygen use or anticipated oxygen desaturation < 85% at peak exercise (patients who desaturate below 85% on the incremental study will be excluded)
  4. 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
  5. An exacerbation requiring therapy or any change in maintenance COPD therapy within six weeks of testing
  6. A history of a prolonged QT interval
  7. Recent exacerbation of COPD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
St Francis Hospital and Medical center
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Saint Francis Care
Sunovion
Investigators
Principal Investigator: Richard ZuWallack, MD Saint Frnacis Hospital
  More Information

No publications provided

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT00773786     History of Changes
Other Study ID Numbers: ASRC956
Study First Received: October 14, 2008
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Francis Care:
COPD
Bronchodilator
arformoterol
tiotropium

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Tiotropium
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on September 18, 2014