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A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo

NCT01136382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2014-08-01

Study results available
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Summary

This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years

Conditions

Interventions

DRUG

budesonide

pMDI, inhalation, bid, 6 weeks

DRUG

placebo

pMDI, inhalation, bid, 6 weeks

Sponsors & Collaborators

Principal Investigators

  • Göran Eckerwall, MD · AZ R&D Mölndal

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
2010-07-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States
  • Bulgaria
  • Hungary
  • Latvia
  • Poland
  • Slovakia
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
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 NCT01136382 on ClinicalTrials.gov