Ciclesonide 160micrograms/dose inhaler CFC free

BACKGROUND AND AIM: The pharmacological profile of ciclesonide suggests that it may be associated with fewer local and systemic adverse effects compared to other inhaled corticosteroids. The aim of this systematic review is to provide an update on the current evidence of the local and systemic adverse effects of ciclesonide for the treatment of asthma compared to other inhaled corticosteroids. METHODS: Systematic review performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-guidelines. The search was last updated in September 2024. The search algorithm consisted of the following Medical Subject Headings (MeSH) terms: (ciclesonide) AND (asthma). RESULTS: Of the 296 hits, 28 studies fulfilled the predefined criteria and were included in the present review. A total of 15 out of 25 studies addressing local adverse effects showed insignificant differences between ciclesonide and the comparative inhaled corticosteroid. Of these 15 studies, 13 were randomized controlled trials (RCTs). Seven RCTs reported a reduced risk of local adverse effects associated with ciclesonide-treatment. One observational study found ciclesonide treated patients more likely to have been treated for oropharyngeal candidiasis compared to patients treated with another inhaled corticosteroid. Twelve studies investigated systemic adverse effects of CIC vs. other inhaled corticosteroid. Of the nine trials measuring urine cortisol suppression compared to baseline, seven found no suppression in the ciclesonide treated groups in contrast to a significant suppression in the comparative inhaled corticosteroid treated groups. On the contrary, two trials found no suppression in either treatment group. Two of three studies assessing HPA-axis function by plasma cortisol response to corticotropin-releasing factor reported no difference between ciclesonide and fluticasone propionate, whereas one found significantly reduced response with fluticasone treatment, but not with ciclesonide. One study assessed the risk of developing signs of cataract and found no significant difference between ciclesonide and other inhaled corticosteroids, and another investigated patient reported adverse effects and found superiority in CIC to FP in terms of reducing "vision deterioration". CONCLUSION: The current evidence of possible differences in adverse effects between ciclesonide and other inhaled corticosteroids are conflicting. However, there is some evidence in favor of fewer local adverse effects in ciclesonide treated patients and, additionally, ciclesonide treatment is either more favorable or similar to other inhaled corticosteroids with regard to systemic adverse effects.

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BACKGROUND AND OBJECTIVES: Inhaled corticosteroids have been proposed as treatment for acute COVID-19 infection in the community. We sought to determine the efficacy and safety of inhaled ciclesonide 320 mcg daily for 14 days compared to placebo in reducing the time to first recovery from all symptoms within 28 days of randomisation. METHODS: We conducted a two-arm, double blind, placebo-controlled, community-based randomised trial. Participants received inhaled ciclesonide 320 mcg daily or matching placebo for 14 days. The primary outcome was time to recovery of symptoms to day 28. An updated systematic review of all controlled trials of inhaled corticosteroids for acute COVID-19 was then undertaken. RESULTS: There were 189 people randomised and 185 completed treatment; 96% were COVID-19 vaccinated. No difference was seen in the time to first recovery using a proportional hazards analysis, recovery rate ratio 1.04 (95% CI; 0.77, 1.40). The median time to recovery with ciclesonide was 7 days (95% CI 6-9), compared with placebo of 7 days (95% CI 6-9), p = 0.84. There were no significant differences in secondary outcomes, including time to sustained recovery and respiratory symptoms. The treatment was safe and well tolerated. CONCLUSION: In a highly vaccinated (> 90%) population exposed to Omicron variants of SARS-CoV-2, the addition of inhaled ciclesonide had no effect on accelerating recovery from acute symptoms. These trial results and updated combined evidence of placebo-controlled trials do not support the use of inhaled corticosteroids for the treatment of COVID-19. TRIAL REGISTRATION: ACTRN12620000566932.

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OBJECTIVE: To determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19. DESIGN: Randomised, double blind, placebo controlled trial. SETTING: Three Canadian provinces (Quebec, Ontario, and British Columbia). PARTICIPANTS: 203 adults aged 18 years and older with polymerase chain reaction confirmed covid-19, presenting with fever, cough, or dyspnoea. INTERVENTION: Participants were randomised to receive either inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) or metered dose inhaler and nasal saline placebos for 14 days. MAIN OUTCOME MEASURES: The primary outcome was symptom resolution at day 7. Analyses were conducted on the modified intention-to-treat population (participants who took at least one dose of study drug and completed one follow-up survey) and adjusted for stratified randomisation by sex. RESULTS: The modified intention-to-treat population included 203 participants: 105 were randomly assigned to ciclesonide (excluding two dropouts and one loss to follow-up) and 98 to placebo (excluding three dropouts and six losses to follow-up). The median age was 35 years (interquartile range 27-47 years) and 54% were women. The proportion of participants with resolution of symptoms by day 7 did not differ significantly between the intervention group (42/105, 40%) and control group (34/98, 35%); absolute adjusted risk difference 5.5% (95% confidence interval -7.8% to 18.8%). Results might be limited to the population studied, which mainly included younger adults without comorbidities. The trial was stopped early, therefore could have been underpowered. CONCLUSION: Compared with placebo, the combination of inhaled and intranasal ciclesonide did not show a statistically significant increase in resolution of symptoms among healthier young adults with covid-19 presenting with prominent respiratory symptoms. As evidence is insufficient to determine the benefit of inhaled and intranasal corticosteroids in the treatment of covid-19, further research is needed. TRIAL REGISTRATION: ClinicalTrials.gov NCT04435795.

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OBJECTIVE: To assess the efficacy of inhaled ciclesonide in reducing the duration of oxygen therapy (an indicator of time to clinical improvement) among adults hospitalised with COVID-19. DESIGN: Multicentre, randomised, controlled, open-label trial. SETTING: 9 hospitals (3 academic hospitals and 6 non-academic hospitals) in Sweden between 1 June 2020 and 17 May 2021. PARTICIPANTS: Adults hospitalised with COVID-19 and receiving oxygen therapy. INTERVENTION: Inhaled ciclesonide 320 µg two times a day for 14 days versus standard care. MAIN OUTCOME MEASURES: Primary outcome was duration of oxygen therapy, an indicator of time to clinical improvement. Key secondary outcome was a composite of invasive mechanical ventilation/death. RESULTS: Data from 98 participants were analysed (48 receiving ciclesonide and 50 receiving standard care; median (IQR) age, 59.5 (49-67) years; 67 (68%) men). Median (IQR) duration of oxygen therapy was 5.5 (3-9) days in the ciclesonide group and 4 (2-7) days in the standard care group (HR for termination of oxygen therapy 0.73 (95% CI 0.47 to 1.11), with the upper 95% CI being compatible with a 10% relative reduction in oxygen therapy duration, corresponding to a <1 day absolute reduction in a post-hoc calculation). Three participants in each group died/received invasive mechanical ventilation (HR 0.90 (95% CI 0.15 to 5.32)). The trial was discontinued early due to slow enrolment. CONCLUSIONS: In patients hospitalised with COVID-19 receiving oxygen therapy, this trial ruled out, with 0.95 confidence, a treatment effect of ciclesonide corresponding to more than a 1 day reduction in duration of oxygen therapy. Ciclesonide is unlikely to improve this outcome meaningfully. TRIAL REGISTRATION NUMBER: NCT04381364.

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