MedTrace Logo

Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma

NCT02260492 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 879

Last updated 2017-06-15

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

DRUG

OT329 (combination of fluticasone propionate and salmeterol xinafoate)

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

DRUG

Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)

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

DRUG

Placebo

Placebo (lactose) administered via the Solis dry powder inhaler

Sponsors & Collaborators

  • Oriel Therapeutics

    lead INDUSTRY

Principal Investigators

  • Rick Fuller, MD FRCP · Oriel Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260492 on ClinicalTrials.gov