Study in Patients With Asthma

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

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
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)

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

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 identifier: NCT00215358

United States, Colorado
Research Site
Denver, Colorado, United States, 80206
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Director, Clinical Affairs, Dey 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:
Foradil processed this record on March 31, 2015