A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma
A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma
The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.
The drug being tested is called ciclesonide. This study looked at the safety and efficacy of inhaled ciclesonide in children with asthma. The study enrolled 1080 patients.
Participants were randomly assigned to 1 of 4 treatment groups which were undisclosed to the patient and study doctor during the study:• Ciclesonide 40 µg, 80 µg or 160 µg • Placebo- this is similar to study drug but has no active ingredient. Ciclesonide was inhaled via a metered-dose inhaler (MDI with HFA-134a propellant), with or without spacer, once daily in the evening throughout the study. All participants were asked to document daily AM and PM peak expiratory flow (PEF), daytime and nighttime asthma symptom scores and number of puffs of rescue medicine in an electronic diary. This multi-centre trial was conducted worldwide. The overall time to participate in this study was 20 weeks. Participants made multiple visits to the clinic plus a final visit 30 days after the last dose of study drug for a follow-up assessment.
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Vama, 9010, Bulgaria
Bellville - Cape Town -, 7530, South Africa
Durban, Amanzimtoti, 4126, South Africa
Gezina, Pretoria, 84, South Africa
Morningside, Sandton, 2196, South Africa
Mowbray, Cape Town, 7925, South Africa
Panorama / RSA-Cape Town, 7500, South Africa
Tarrasa, 8211, Spain