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

This study has been completed.
Information provided by (Responsible Party):
Saint Francis Care Identifier:
First received: October 14, 2008
Last updated: May 19, 2015
Last verified: December 2013
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
Drug: Arformoterol (Brovana)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, 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:
  • Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week [ Time Frame: baseline and 1 week ]
    Change from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)

Secondary Outcome Measures:
  • Change From Baseline in Forced Vital Capacity (FVC) at 1 Week [ Time Frame: baseline and 1 week ]
    Change from baseline in Forced Vital Capacity (FVC) after 1 week on Brovana or Placebo. (Change = 1 week - baseline)

  • Change From Baseline in Inspiratory Capacity at 1 Week [ Time Frame: baseline and 2 hours after dosing ]
    Change from baseline in Inspiratory Capacity (IC) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline).

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
Drug: Placebo
Placebo twice daily for 1 week (added to maintenance tiotropium)

  Show Detailed Description


Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Informed consent (Approval by the St. Francis Hospital Institutional Review Board (IRB) will be required before study initiation)
  2. Adults, age > 40 years
  3. A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator forced expiratory volume in 1 second / forced vital capacity (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 identifier: NCT00773786

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

Responsible Party: Saint Francis Care Identifier: NCT00773786     History of Changes
Other Study ID Numbers: ASRC956
Study First Received: October 14, 2008
Results First Received: May 29, 2013
Last Updated: May 19, 2015

Keywords provided by Saint Francis Care:

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol Fumarate
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents processed this record on May 25, 2017