The purpose of the study is to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.
A phase-II, double-blind, placebo-controlled, randomised, parallel-group,multi-centre study to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
353
Absolute change from baseline to mean of weeks 8 to 12 in pre-dose forced expiratory volume in 1 sec (FEV1)
Time frame: Baseline (week 0), and at week 8, 10, and 12
Percent change from baseline in twenty-four hour plasma cortisol
Time frame: Baseline (week 0), and at week 4 and 12
Time to first exacerbation (hospitalisation, oral/parenteral corticosteroid, oral/parenteral antibiotics)
Time frame: Baseline(week 0) and week 2, 4, 8, 10, 12 and daily by eDairy
The percent change from baseline in pre-dose hsCRP at week 4 and 12
Time frame: Baseline(week 0), and at week 4 and 12
Profile of pharmacokinetics (PK) of AZD5423 in terms of Cmax, tmax, AUC(0-24h), CL/F, Cav in subset of patients
Time frame: Week 4 and 12
Number of St George's Respiratory Questionnaire (SGRQ-C) responders and Overall Score
Time frame: Baseline(week 0), and at week 4 and 12
Assessment of Baseline/Transitional Dyspnea Index (BDI/TDI) Score
Time frame: Baseline(week 0), and at week 4 and 12
Assessment of Breathlessness, Cough and Sputum Scale (BCSS) Score
Time frame: Daily by eDairy
Absolute change from baseline to mean of week 2 and 4 pre-dose forced expiratory volume in 1 sec (FEV1)
Time frame: Baseline (week 0), and at week 2 and 4.
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Research Site
Doganovo, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Brest, France
Research Site
Marseille, France
Research Site
Montpellier, France
Research Site
Nice, France
Research Site
Pessac, France
Research Site
Balassagyarmat, Hungary
...and 34 more locations
Absolute change from baseline in pre-dose FEV1
Time frame: Baseline (week 0) and at week 2, 4, 8, 10 and 12