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Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler

NCT02980133 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 841

Last updated 2021-11-09

Study results available
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Summary

This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma.

Conditions

Interventions

DRUG

Fluticasone Propionate

Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.

DRUG

Fluticasone Propionate/Salmeterol

Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.

DRUG

Placebo MDPI

Matching placebo was administered via MDPI per the schedule specified in the arm.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-28
Primary Completion
2019-04-07
Completion
2019-04-13
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Hungary
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT02980133 on ClinicalTrials.gov