Martinez Fernando J, Fabbri Leonardo M, Ferguson Gary T, Orevillo Chad, Darken Patrick, Martin Ubaldo J, Reisner Colin
Joan and Sanford Weill Department of Internal Medicine, Weill Cornell Medicine, New York, NY.
Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Chest. 2017 Dec;152(6):1169-1178. doi: 10.1016/j.chest.2017.07.007. Epub 2017 Jul 16.
The clinical severity of COPD is currently categorized by symptom burden and exacerbation risk. Previous 24-week phase III trials (NCT01854645 and NCT01854658) that demonstrated better improvement of lung function with glycopyrrolate/formoterol fumarate (GFF) metered dose inhaler (MDI) (an MDI fixed-dose of GFF 18/9.6 μg) over individual monocomponent MDIs included a cross-section of patients with moderate to very severe airflow limitation and a broad range of COPD symptoms.
These post hoc analyses of pooled data investigated whether baseline symptom burden, assessed using the COPD Assessment Test (CAT) score, impacted GFF MDI-associated improvements in lung function, health status, rescue medication use, and exacerbation risk.
In 3,699 patients, improvement in FEV at week 24 between the GFF MDI and monocomponent MDIs and a placebo MDI was similar in magnitude regardless of baseline CAT score. In contrast, the magnitude of mean difference in the St. George's Respiratory Questionnaire total score for GFF MDI vs monocomponent MDIs and the placebo MDI increased with increasing baseline CAT scores. Likewise, reduced rescue medication use and lower exacerbation risk were more pronounced in GFF MDI groups with a higher baseline symptom burden.
Beneficial effects of GFF MDI on health status, rescue medication use, and exacerbation risk in symptomatic patients with COPD increased as a function of baseline symptom burden, whereas lung function benefits were independent. These data suggest a greater clinical benefit from dual bronchodilators in symptomatic patients than in patients without symptoms.
ClinicalTrials.gov; No.: NCT01854645 and NCT01854658; URL: www.clinicaltrials.gov.
慢性阻塞性肺疾病（COPD）的临床严重程度目前根据症状负担和急性加重风险进行分类。先前的24周III期试验（NCT01854645和NCT01854658）表明，与单独的单一组分定量吸入器相比，格隆溴铵/富马酸福莫特罗（GFF）定量吸入器（GFF 18/9.6μg的固定剂量定量吸入器）能更好地改善肺功能，试验纳入了具有中度至非常严重气流受限且伴有广泛COPD症状的患者。
这些对汇总数据的事后分析调查了使用慢性阻塞性肺疾病评估测试（CAT）评分评估的基线症状负担是否会影响GFF定量吸入器在肺功能、健康状况、急救药物使用和急性加重风险方面的改善。
在3699例患者中，无论基线CAT评分如何，GFF定量吸入器与单一组分定量吸入器及安慰剂定量吸入器相比，在第24周时第1秒用力呼气容积（FEV）的改善幅度相似。相比之下，GFF定量吸入器与单一组分定量吸入器及安慰剂定量吸入器相比，圣乔治呼吸问卷总分的平均差异幅度随基线CAT评分的增加而增大。同样，在基线症状负担较高的GFF定量吸入器组中，急救药物使用的减少和急性加重风险的降低更为明显。
GFF定量吸入器对有症状的COPD患者的健康状况、急救药物使用和急性加重风险的有益影响随基线症状负担的增加而增加，而对肺功能的益处则与之无关。这些数据表明，与无症状患者相比，双重支气管扩张剂对有症状患者的临床益处更大。
ClinicalTrials.gov；编号：NCT01854645和NCT01854658；网址：www.clinicaltrials.gov。
