Study in Patients With Asthma

This study has been completed.
Information provided by:
Dey Identifier:
First received: September 13, 2005
Last updated: November 10, 2010
Last verified: February 2008
The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.

Condition Intervention Phase
Drug: Formoterol Fumarate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Dey:

Primary Outcome Measures:
  • Measure of lung function

Secondary Outcome Measures:
  • Change in lung function, as well as vital signs
  • Physical Exam results, AE reporting, etc

Estimated Enrollment: 36
Study Completion Date: October 2005
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children with a history of asthma
  • Written guardian approval

Exclusion Criteria:

  • Current or recent asthma exacerbation, requiring hospitalization
  • History of smoking
  • Debilitating or systemic and/or life-threatening diseases.
  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: NCT00215410

United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72205
United States, California
Research Site
Long Beach, California, United States, 90806
Research Site
Mission Viejo, California, United States, 92691
Research Site
Newport Beach, California, United States, 92660
Research Site
Orange, California, United States, 92888
Research Site
Vista, California, United States, 92084
United States, Colorado
Research Site
Englewood, Colorado, United States, 80112
United States, Oklahoma
Research Site
Oklahoma, Oklahoma, United States, 73120
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
Research Site
Portland, Oregon, United States, 97213
United States, Texas
Research Site
Fort Worth, Texas, United States, 76107
Research Site
Houston, Texas, United States, 77054
Sponsors and Collaborators
  More Information

Responsible Party: Director, Clinical Affairs, Dey Identifier: NCT00215410     History of Changes
Other Study ID Numbers: DL-055 
Study First Received: September 13, 2005
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:

Additional relevant MeSH terms:
Formoterol Fumarate
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 25, 2016