Bronchodilator reversibility in patients with COPD revisited: short-term reproducibility.
Categorization of patients with COPD as reversible or nonreversible to a bronchodilator may change over time. This post hoc analysis aimed to determine if an individual's reversibility, when treated as a continuous variable, could predict his/her future response to two short-acting bronchodilators: albuterol and ipratropium. The analysis was completed using data from a 4-week, randomized, open-label, two-period crossover study (NCT01691482; GSK study DB2114956). Patients received albuterol (doses: UK =4×100 μg/puff; US =4×90 μg/puff) followed 1 hour later by ipratropium (4×20 μg/puff) or vice versa during treatment Period 1. The order of treatments was reversed during Period 2. Predefined efficacy end points included pre- and post-bronchodilator forced expiratory volume in 1 second. The correlation coefficient between bronchodilator response on Days 1 and 10 was investigated, as well as the correlation between treatment response on Day 1 and the mean treatment response on Days 5-10, for each individual patient. Bronchodilator response to albuterol on Day 1 was strongly correlated with that on Day 10 (r=0.64; n=53). The correlation coefficient of bronchodilator treatment response on Day 1 and Days 5-10 was 0.78 (P<0.001; n=53) and 0.76 (P<0.001; n=54) for albuterol and ipratropium, respectively. A single measurement of the initial bronchodilator response to albuterol or ipratropium was, therefore, highly correlated with the subsequent mean bronchodilator response over 5-10 days, demonstrating its potential usefulness for future treatment decisions.
GSK, Respiratory Medicines Development Center.
Steven
S
Pascoe
PAREXEL International, Research Triangle Park, NC, USA.
Wei
W
Wu
GSK, Clinical Statistics (Respiratory), Middlesex, UK.
Chang-Qing
CQ
Zhu
Medicines Evaluation Unit, University Hospital of South Manchester NHS Foundation Trust, University of Manchester, Manchester, UK.
Dave
D
Singh
D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage* / Q000009:adverse effects; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004739:England; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage* / Q000009:adverse effects; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D020127:Recovery of Function; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D018727:Muscarinic Antagonists; D009241:Ipratropium; D000420:Albuterol
FEV1; bronchodilator responsiveness; correlation; short-acting bronchodilators; spirometry