A Randomised, Placebo-Controlled, Dose-Finding Study Of AZD9668, An Oral Inhibitor of Neutrophil Elastase, in Patients with Chronic Obstructive Pulmonary Disease Treated with Tiotropium
COPD: Journal of Chronic Obstructive Pulmonary Disease, 04/06/2012
Vogelmeier C et al. – AZD9668 was well tolerated; the numbers of patients with adverse events (AEs), serious AEs and AEs leading to discontinuation were similar in each of the four study groupsMethods
- Efficacy, safety and tolerability of AZD9668 (5, 20 and 60 mg bid) were compared with placebo in a randomised, double–blind, placebo–controlled, 12–week, Phase IIb trial (NCT00949975: approved by an Investigational Review Board), in patients with symptomatic COPD receiving maintenance tiotropium.
- The primary endpoint was pre–bronchodilator forced expiratory volume in 1 second (FEV1).
- Secondary endpoints included forced vital capacity and inspiratory capacity, peak expiratory flow, Breathlessness, Cough and Sputum Scale score, exercise capacity, quality of life (QoL), exacerbation assessments, safety and pharmacokinetics.
- Exploratory endpoints included inflammatory and tissue degradation biomarkers.
- A total of 838 patients were randomised to AZD9668 5 mg bid (212 patients), 20 mg bid (206 patients), 60 mg bid (202 patients) or placebo (218 patients).
- AZD9668 showed no effect on lung function, respiratory signs and symptoms, QoL or biomarkers.
- At end of treatment, the change in mean pre–bronchodilator FEV1 for AZD9668 60 mg bid compared with placebo was 0.00L (95%% confidence interval: –0.05, 0.04; p == 0.873).
- Overall, AZD9668 was well tolerated; the numbers of patients with adverse events (AEs), serious AEs and AEs leading to discontinuation were similar in each of the four study groups.