Study in Patients With Asthma

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215397
• Other study ID #: DL-053
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: November 10, 2010
• Est. completion date: December 2005

Study information

• Verified date: February 2008
• Source: Dey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2005
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Formoterol Fumarate

Locations

Country	Name	City	State
United States	Research Site	Denver	Colorado
United States	Research Site	Long Beach	California
United States	Research Site	Medford	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Dey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome variable is the measure of lung function.
Secondary	Secondary outcomes include change in lung function, as well as in vital signs.
Secondary	Physical exams, AE reporting, etc.