MedTrace Logo

Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children

NCT01450774 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-03-29

No results posted yet for this study

Summary

This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.

Conditions

  • Childhood Asthma

Interventions

DRUG

CHF 1535 50/6µg

fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

DRUG

beclomethasone dipropionate 50µg + formoterol fumarate 6µg

free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Hans Bisgaard, MD · BørneAstmaKlinikken

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-11-30
Completion
2014-02-28

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT01450774 on ClinicalTrials.gov