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A SINGLE CENTRE DOUBLE-BLIND, RANDOMISED 3 PERIOD CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF BECLOMETHASONE DIPROPIONATE HFA pMDI 100 AND 200 µg B.I...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-003412-59

A SINGLE CENTRE DOUBLE-BLIND, RANDOMISED 3 PERIOD CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF BECLOMETHASONE DIPROPIONATE HFA pMDI 100 AND 200 µg B.I.D. USING AEROCHAMBER PLUS™ SPACING DEVICE AND BECLOMETHASONE DIPROPIONATE HFA pMDI 200 µg B.I.D. USING THE VOLUMATIC™ SPACING DEVICE IN CHILDREN WITH MILD ASTHMA DURING A 2–WEEK TREATMENT PERIOD

Femme et Homme

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Extrait

The primary objective of the study is to compare lower leg growth rate (LLGR), measured by knemometry, over a 2-week treatment period with BDP HFA pMDI 200 µg b.i.d. using AeroChamber Plus™ spacing device versus BDP HFA pMDI 200 µg b.i.d. using Volumatic™ spacing device. The study is aiming at showing non-inferiority of BDP HFA 200 µg administered via AeroChamber Plus™ spacer vs. the same treatment administered via Volumatic™ spacer.

Critère d'inclusion

  • Mild asthma in children (males and females) 6-14 years

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