Phase 4
Completed N=25
Single Dose Bronchodilatory Study in Asthma
Source: ClinicalTrials.gov NCT01805687 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Change From Baseline in FEV1 — 2.84 Liter
Summary
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.
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 |
— | — |
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
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. Informational only — not medical advice.