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Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients

NCT03015259 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1762

Last updated 2022-08-24

Study results available
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Summary

A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation aerosol.

Conditions

Interventions

DRUG

Budesonide/Formoterol fumarate dihydrate

Experimental: Treatment 1

DRUG

Symbicort

Active Comparator: Treatment 2

DRUG

Placebo

Placebo Comparator: Treatment 3

Sponsors & Collaborators

  • Kindeva Drug Delivery

    lead INDUSTRY

Principal Investigators

  • KINDEVA I DD, PhD · Kindeva Drug Delivery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-29
Primary Completion
2018-02-08
Completion
2018-02-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03015259 on ClinicalTrials.gov