CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 879 enrolled
Drug / intervention
OT329 (combination of fluticasone propionate and salmeterol xinafoate) +2 moredrug
Likely dose
OT329 (combination of fluticasone propionate and salmeterol xinafoate) 100 mcgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02260492
NCT02260492Phase 1Completed
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Clinical Endpoint Study of Salmeterol Xinafoate/Fluticasone Propionate Combination for Comparison of a Test and Reference Product in Patients With Asthma

Oriel Therapeutics·interventional·Posted Oct 9, 2014·Updated Jun 15, 2017

In Brief

A Phase 1 clinical trial evaluating OT329 (combination of fluticasone propionate and salmeterol xinafoate), Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate), and 1 other intervention for Asthma. Completed, enrolled 879 participants across 47 sites.

Detailed Summary

This is a study to establish the equivalence of OT329 Solis and Advair Diskus when administered by inhalation in patients with asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 9, 2014
Enrollment StartSep 1, 2014
Primary CompletionMay 1, 2015
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.7 years ago

Interventions

OT329 (combination of fluticasone propionate and salmeterol xinafoate)drug

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler

Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)drug

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler

Placebodrug

Placebo (lactose) administered via the Solis dry powder inhaler