A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 micrograms o.d. [once daily] Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 micrograms b.i.d. [twice daily] as Active Control.
Phase of Trial: Phase III
Latest Information Update: 27 Apr 2015
At a glance
- Drugs Indacaterol (Primary) ; Salmeterol
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Sponsors Novartis
- 31 Aug 2018 Biomarkers information updated
- 23 Jun 2012 Company added in the association field as reported by EudraCT.
- 12 May 2012 Planned number of patients changed from 78 to 80 as reported by European Clinical Trials Database record.