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Study in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00215397
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 the most safe and effective in the treatment of asthma compared to the control drug.


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:
  • The primary outcome variable is the measure of lung function.

Secondary Outcome Measures:
  • Secondary outcomes include change in lung function, as well as in vital signs.
  • Physical exams, AE reporting, etc.

Estimated Enrollment: 16
Study Completion Date: December 2005
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a history of asthma

Exclusion Criteria:

  • Current asthma exacerbation or recent asthma exacerbation, requiring hospitalization
  • History of smoking
  • Debilitating systemic and/or life-threatening diseases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215397

Locations
United States, California
Research Site
Long Beach, California, United States, 90806
United States, Colorado
Research Site
Denver, Colorado, United States, 80206
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: NCT00215397     History of Changes
Other Study ID Numbers: DL-053
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
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 19, 2013