Study in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00215358
First received: September 13, 2005
Last updated: November 10, 2010
Last verified: February 2008
  Purpose

The purpose of this study is to determine which dose of the investigational drug is safest and most effective 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:


Further study details as provided by Dey:

Primary Outcome Measures:
  • Measure of lung function.

Secondary Outcome Measures:
  • Change in lung function, vital signs, physical examinations, clinical laboratory assessments, and adverse event reporting.

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

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Require regular use of an inhaled Beta-2-selective adrenergic agent

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
  • Recent surgical interventions such as lung lobectomy or resection (< one year), or cardiothoracic interventions
  • Life-threatening systemic and debilitating 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: NCT00215358

Locations
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: NCT00215358     History of Changes
Other Study ID Numbers: DL-048
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
Foradil

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Formoterol
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
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014