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Study in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00215371
First received: September 13, 2005
Last updated: November 10, 2010
Last verified: February 2008
History of Changes
  Purpose

The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.


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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Dey:

Primary Outcome Measures:
  • Primary: The primary efficacy outcome is measure of lung function.

Secondary Outcome Measures:
  • Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, adverse event reporting,etc.

Estimated Enrollment: 32
Study Start Date: July 2002
Study Completion Date: November 2005
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Require the regular use of an inhaled beta-2-selective adrenergic agent.
  • No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.

Exclusion Criteria:

  • Active acute or chronic disorders of the respiratory system within one month prior to screening.
  • Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history.
  • Debilitating systemic and/or life-threatening diseases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215371

Locations
United States, California
Research Site
Long Beach, California, United States, 90806
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
Sponsors and Collaborators
Dey
  More Information

No publications provided

Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00215371     History of Changes
Other Study ID Numbers: DL-050
Study First Received: September 13, 2005
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
Asthma
Pediatric
Formoterol Fumarate
Foradil

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

ClinicalTrials.gov processed this record on May 16, 2013