Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ciclesonide; Fluticasone

Criteria

Main Inclusion Criteria:

• History of persistent bronchial asthma for at least 6 months

• FEV1 50-90% of predicted

Main Exclusion Criteria:

• Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids

• COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function

• Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study

• History of life-threatening asthma

• Premature birth

• Current smoking

• Smoking history with either equal or more than 10 pack-years

• Pregnancy

• Intention to become pregnant during the course of the study

• Breast feeding

• Lack of safe contraception