At a glance
ClinicalIndex Comparison Record- ✓Diagnosed asthma for at least 12 months with consistent symptoms
- ✓FEV1 at least 80% of predicted
- ✓History of reversible airway obstruction
- ✓Outpatient status
- ✕History of life-threatening asthma
- ✕Hospitalization for asthma within the last 3 months, or more than two hospitalizations within the last year
- ✕Concomitant severe diseases or contraindications for inhaled steroids
- ✕Relevant lung diseases causing alternating impairment in lung function (e.g., chronic bronchitis or emphysema)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations
In Brief
A Phase 3 clinical trial evaluating Ciclesonide and Placebo for Asthma. Completed, enrolled 240 participants across 7 sites in 3 countries.
Detailed Summary
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
Study Details
Timeline
Interventions
Ciclesonide metered-dose inhaler
Ciclesonide placebo-matching metered-dose inhaler