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A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy

NCT01136655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-10-31

Study results available
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Summary

This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.

Conditions

Interventions

DRUG

80/2.25 μg Symbicort pMDI

inhalation

DRUG

80/4.5 μg Symbicort pMDI

inhalation

DRUG

Foradil Aerolizer 12 μg

inhalation

DRUG

40 μg budesonide HFA pMDI

inhalation

DRUG

placebo HFA pMDI

inhalation

Sponsors & Collaborators

Principal Investigators

  • Lars-Goran Carlsson, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Bulgaria
  • Czechia
  • Hungary
  • Poland
  • South Africa

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 NCT01136655 on ClinicalTrials.gov