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Study in Patients With Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215371
First Posted: September 22, 2005
Last Update Posted: November 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dey
  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
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00215371     History of Changes
Other Study ID Numbers: DL-050
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: November 11, 2010
Last Verified: February 2008

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 Fumarate
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