MedTrace Logo

A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics

NCT02126839 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2021-11-09

Study results available
· View outcomes & findings →

Summary

The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.

Conditions

Interventions

DRUG

Albuterol MDPI

90 mcg/actuation of the multidose dry powder inhaler (MDPI).

DRUG

Placebo

Matching Placebo delivered via a multidose dry powder inhaler (MDPI).

DRUG

ProAir HFA inhaler

Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States
  • Thailand

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 NCT02126839 on ClinicalTrials.gov