Phase 4 N=25 Treatment

Single Dose Bronchodilatory Study in Asthma

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT01805687 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Change From Baseline in FEV1 — 2.84 Liter

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Zileuton extended release (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Cornerstone Therapeutics Inc.
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in FEV1	2.84	—
SECONDARY Area Under the Curve (AUC)	—	—
SECONDARY Number of Subjects With Adverse Events	—	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01805687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.