Single Dose Bronchodilatory Study in Asthma

Cornerstone Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Zileuton extended release

Study type: Interventional

Funder types: Industry

Identifiers

NCT01805687

CRTX 082-04-01

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Zileuton extended release

Other group

Description:

Oral, 1200 mg (2 x 600 mg tablets)

Treatment:

Drug: Zileuton extended release