This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already receiving maintenance therapy with inhaled fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.) via multi-dose dry powder inhaler (MDDPI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
NVA237 (50µg, o.d. via SDDPI) in the morning,
Placebo to NVA237
Trough Forced Expiratory Volume in 1 second (FEV1)
Comparison of NVA237 treatment versus placebo treatment in the trough FEV1 after 12 weeks of treatment
Time frame: after 12 weeks of treatment
Total score of St George's Respiratory Questionnaire for COPD patients (SGRQ-C).
Comparison of NVA237 treatment versus placebo treatment in terms of change in SGRQ-C after 26 weeks of treatment
Time frame: 26 weeks
Trough Forced Expiratory Volume in 1 second (FEV1)
Comparison of effect of NVA237 treatment versus placebo treatment in FEV1 after 4 weeks and after 26 weeks of treatment
Time frame: week 4 , week 26
Total score of the Transition Dyspnea Index (TDI)
Comparison of effect of NVA237 treatment versus placebo treatment in the total TDI score after 12 weeks and after 26 weeks of treatment
Time frame: Week 12 and week 26
Assessment of safety and tolerability
All safety endpoints will be summarized for the safety set.
Time frame: 26 Weeks
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