Department of Medicine, Division of Respirology, McGill University Health Centre, Montreal, Quebec, Canada
Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.
BMJ. 2021 Nov 2;375:e068060. doi: 10.1136/bmj-2021-068060.
To determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19.
Randomised, double blind, placebo controlled trial.
Three Canadian provinces (Quebec, Ontario, and British Columbia).
203 adults aged 18 years and older with polymerase chain reaction confirmed covid-19, presenting with fever, cough, or dyspnoea.
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.
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.
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.
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.
ClinicalTrials.gov NCT04435795.
确定吸入和鼻内昔萘酸昔布在降低 COVID-19 成年门诊患者呼吸道症状方面是否优于安慰剂。
随机、双盲、安慰剂对照试验。
加拿大三个省份（魁北克、安大略和不列颠哥伦比亚）。
203 名年龄在 18 岁及以上、聚合酶链反应证实 COVID-19 阳性、有发热、咳嗽或呼吸困难的成年人。
参与者随机接受吸入昔萘酸昔布（600μg，每日 2 次）和鼻内昔萘酸昔布（200μg，每日 1 次）或计量吸入器和鼻腔生理盐水安慰剂治疗 14 天。
主要结局为第 7 天症状缓解。分析采用改良意向治疗人群（至少接受一剂研究药物并完成一次随访调查的参与者）进行，并按性别分层随机化进行调整。
改良意向治疗人群包括 203 名参与者：105 名随机分配至昔萘酸昔布组（包括 2 名脱落和 1 名失访），98 名随机分配至安慰剂组（包括 3 名脱落和 6 名失访）。中位年龄为 35 岁（四分位距 27-47 岁），54%为女性。第 7 天症状缓解的参与者比例在干预组（42/105，40%）和对照组（34/98，35%）之间无显著差异；绝对调整风险差异 5.5%（95%置信区间-7.8%至 18.8%）。结果可能仅限于研究人群，该人群主要包括年轻、无合并症的成年人。由于试验提前停止，因此可能存在效力不足的情况。
与安慰剂相比，在有明显呼吸道症状的 COVID-19 轻症年轻成年患者中，吸入和鼻内昔萘酸昔布联合治疗并未显示出症状缓解的统计学显著增加。由于吸入和鼻内皮质类固醇治疗 COVID-19 的益处证据不足，因此需要进一步研究。
ClinicalTrials.gov NCT04435795。
