Related Experiment Video
Updated: Jun 14, 2026
Bronchial Thermoplasty: A Novel Therapeutic Approach to Severe Asthma
Published on: November 4, 2010
Safety of ciclesonide in children with asthma: A review of randomized controlled trials
Michael Blaiss1, William Berger2, Bradley Chipps3
1From the Department of Pediatrics, Medical College of Georgia at Augusta University, Augusta, Georgia.
Insights
Ciclesonide (CIC) is a safe inhaled corticosteroid for children with asthma, showing low adverse effects and no systemic impact. This asthma medication offers an ideal safety profile for pediatric use.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Respiratory Medicine
Background:
- Parental concerns regarding adverse effects of asthma medications can lead to nonadherence and uncontrolled asthma in children.
- Ciclesonide (CIC), a prodrug, exhibits low oropharyngeal deposition and bioavailability, potentially minimizing local and systemic adverse effects.
- CIC is FDA-approved for asthma treatment in children aged 12 years and older.
Purpose of the Study:
- To summarize safety findings from 13 randomized controlled trials (Phase II/III) involving children with asthma during Ciclesonide (CIC) clinical development.
- To evaluate the safety profile of Ciclesonide in pediatric asthma patients.
Main Methods:
- Conducted 13 randomized controlled trials (II/III) in children with asthma.
- Compared once-daily Ciclesonide (CIC) doses (40-160 µg/day) against placebo, fluticasone, or budesonide in trials ranging from 12 to 24 weeks.
- Assessed long-term safety, growth velocity, and hypothalamic-pituitary-adrenal (HPA) axis effects over 12 months in specific trials.
Main Results:
- A total of 4399 children received Ciclesonide (CIC) treatment.
- Treatment-emergent adverse events (AE) were similar across CIC doses and between CIC and placebo/active controls.
- No CIC-related serious AEs were reported; oral candidiasis rates were low and comparable across groups. No clinically relevant HPA axis suppression or growth reduction was observed.
Conclusions:
- Data from 13 studies confirm Ciclesonide (CIC) is associated with low oropharyngeal adverse events (AEs) and no clinically significant systemic effects in pediatric asthma patients.
- The favorable safety profile of Ciclesonide, coupled with demonstrated asthma control improvements, positions it as an ideal inhaled corticosteroid for treating asthma in children.
Abstract:
Background: Parental concerns about the adverse effects of asthma medications can lead to nonadherence and uncontrolled asthma in children. Ciclesonide (CIC) is a prodrug, with low oropharyngeal deposition and bioavailability that may minimize the risk of local and systemic adverse effects. CIC is U.S. Food and Drug Administration approved for asthma in children ages ≥ 12 years. Objective: To summarize safety results from the 13 phase II or III randomized controlled trials conducted in children with asthma during CIC clinical development. Methods: Four 12- to 24-week trials compared the safety of once-daily CIC 40, 80, or 160 µg/day with placebo; four 12-week trials compared the safety of CIC 80 or 160 µg/day with either fluticasone or budesonide; one 12-month trial compared the long-term safety of CIC 40, 80, or 160 µg/day with fluticasone; one 12-month trial compared growth velocity of CIC 40 or 160 µg/day with placebo; and three cross-over trials compared short-term growth velocity and hypothalamic-pituitary-adrenal (HPA) axis effects of CIC 40, 80, or 160 µg/day with placebo or fluticasone. Results: In all, 4399 children were treated with CIC. The incidence of treatment-emergent adverse events (AE) was similar among the CIC doses and between CIC and placebo in short-term studies and between CIC and fluticasone in the long-term safety study. No CIC-related serious AEs were reported in any study. The incidence of treatment-related oral candidiasis was low and similar between CIC (≤0.5%) and placebo (≤0.7%) or active controls (≤0.5%) in the short-term studies. There was no clinically relevant HPA axis suppression or reduction in growth velocity associated with CIC. Conclusion: Data from 13 studies demonstrate that CIC is associated with low rates of oropharyngeal AEs, with no indication of clinically relevant systemic effects in children with asthma. The favorable safety profile and demonstrated improvements in asthma control make CIC an ideal inhaled corticosteroid for the treatment of asthma in children.
More Related Videos
Related Concept Videos
01:23Upper Respiratory Drugs: Antitussives, Expectorants, and Mucolytics
Antitussives include codeine, dextromethorphan (Robitussin), and benzonatate (Tessalon). Codeine and dextromethorphan exert their effects centrally by suppressing the cough reflex center in the medulla. Benzonatate operates peripherally within the respiratory tract by anesthetizing...
01:19Antiasthma Drugs: Leukotriene Modifiers
Leukotriene modifiers work through two distinct mechanisms:
01:25Antiasthma Drugs: Inhaled Corticosteroids and Glucocorticoids
ICS work through a multifaceted mechanism of action. They suppress the inflammatory response caused by the proliferation of TH cells. They also reduce the transcription of the IL-2 gene, which is involved in the...
01:25Antiasthma Drugs: Mast Cell Stabilizers and Anti-IgE Drugs
Mast cell stabilizers, such as cromolyn (also known as sodium cromoglycate) and nedocromil (Tilade), are effective drugs in asthma management. These stabilizers hinder histamine release by skillfully obstructing the activation of mast cells and other cellular entities. Notably, they navigate this task without...
01:26Asthma-II: Pathophysiology and Classification
Additionally, environmental and genetic factors play crucial roles in determining an individual's susceptibility to asthma and the severity of their condition.
Critical processes in asthma pathophysiology include:
01:30Asthma-IV: Diagnostic and Management
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes: