The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID compared with placebo on COPD symptoms in a symptomatic patients population with moderate COPD and chronic bronchitis, and particularly assess the effects in cough by using specific tools to assess the occurrence and impact of this relevant COPD symptom.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler
Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler
Research Site
Berlin, Germany
Research Site
Dortmund, Germany
Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period
The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms
Time frame: Baseline to Week 8
Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period
The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms
Time frame: Baseline to Week 8
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8
The LCQ is a self-administered questionnaire that assesses cough related quality of life The LCQ comprises 19 items and 3 domains (physical, psychological and social) The total score ranges from 3 to 21 and each domain scores range from 1 to 7; a higher score indicates a better quality of life
Time frame: Week 8
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Research Site
Frankfurt, Germany
Research Site
Frankfurt am Main, Germany
Research Site
Hanover, Germany
Research Site
Lübeck, Germany
Research Site
Balassagyarmat, Hungary
Research Site
Debrecen, Hungary
Research Site
Komárom, Hungary
Research Site
Nyíregyháza, Hungary
...and 14 more locations