Study in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00215410
First received: September 13, 2005
Last updated: November 10, 2010
Last verified: February 2008
  Purpose

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
Asthma
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)
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00215410

Locations
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
Dey
  More Information

No publications provided

Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov 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:
Asthma
Formoterol
Fumarate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014