AI Article Synopsis
- The study aimed to explore the use of CT scans in a multicenter trial to evaluate structural changes in the airways of COPD patients.
- It involved a 12-week, double-blind trial comparing the effects of AZD9668, a neutrophil elastase inhibitor, against a placebo on various airway metrics in older ex-smokers.
- While the primary measure of airway wall thickness showed no significant difference, some secondary measures indicated improvements for those on AZD9668, and the treatment was generally well tolerated.
Article Abstract
Introduction: The aim of this study was to establish the feasibility of using computed tomography (CT) in a multicenter setting to assess structural airway changes.
Methods: This was a 12-week, randomized, double-blind, placebo-controlled, Phase IIb trial using CT to investigate the effect of a novel, oral, reversible neutrophil elastase inhibitor, AZD9668 60 mg twice daily (BID), on structural airway changes in patients aged 50-80 years with chronic obstructive pulmonary disease (COPD) (ex-smokers).
Primary Outcome Variable: airway wall thickness at an extrapolated interior perimeter of 10 mm (AWT-Pi10). Secondary outcome variables: fifth-generation wall area %; air trapping index; pre- and post-bronchodilator forced expiratory volume in 1 s (FEV1); morning and evening peak expiratory flow and FEV1; body plethysmography; EXAcerbations of Chronic pulmonary disease Tool (EXACT); Breathlessness, Cough, and Sputum Scale (BCSS); St George's Respiratory Questionnaire for COPD; and proportion of reliever-medication-free trial days. Safety variables were also assessed.
Results: There was no difference between placebo (n = 19) and AZD9668 (n = 17) for AWT-Pi10 at treatment end. This was consistent with results for most secondary variables. However, patients randomized to AZD9668 experienced an improvement versus placebo for morning and evening FEV1, and EXACT and BCSS cough and sputum scores. AZD9668 60 mg BID was well tolerated and no new safety concerns were identified.
Conclusions: This study confirmed the feasibility of using CT to assess structural airway changes in COPD. However, there was no evidence of improvements in CT structural measures following 12 weeks' treatment with AZD9668 60 mg BID.
Funding: AstraZeneca.
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| http://dx.doi.org/10.1007/s12325-015-0215-3 | DOI Listing |
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