Single Dose Bronchodilatory Study in Asthma

Asthma Clinical Trial

Official title:

A Single-Center, Open-Label, Single-Dose Evaluation of the Duration and Extent of Bronchodilation Following Administration of Zileuton CR 1200 mg in Subjects With Stable, Chronic Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805687
• Other study ID #: CRTX 082-04-01
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2013
• Last updated: August 22, 2014
• Start date: March 2013

Study information

• Verified date: August 2014
• Source: Cornerstone Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosis of asthma for at least 5 years

• FEV1 of 50-85% predicted

• Reversible airway obstruction

Exclusion Criteria:

• Pregnant/nursing females

• Liver function tests greater than upper limit of normal

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Zileuton extended release

Locations

Country	Name	City	State
United States	Northeast Medical Research Associates	North Dartmouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cornerstone Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in FEV1		12 Hours	No
Secondary	Area Under the Curve (AUC)		72 Hours	No
Secondary	Number of Subjects With Adverse Events		72 Hours	Yes