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A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg

NCT02091986 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 882

Last updated 2017-04-10

Study results available
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Summary

The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma during 12 weeks.

Conditions

Interventions

DRUG

Symbicort pMDI

Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily

DRUG

Symbicort pMDI

Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily

OTHER

Budesonide pMDI

Budesonide pMDI 80µg, 2 acuations twice daily

Sponsors & Collaborators

Principal Investigators

  • David S Pearlman, MD · Colorado Allergy Asthma Centers, PC, US

  • Carin Jorup, MD · AstraZeneca Mölndal, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States
  • Mexico
  • Panama
  • Slovakia

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02091986 on ClinicalTrials.gov