A 12-Week Treatment, Multi-Center, Randomized, Parallel Group, Blinded, Double Dummy Study to Compare the Efficacy and Safety of Indacaterol (150 microg o.d.) Delivered Via a SDDPI With Tiotropium (18 microg o.d.) Delivered Via a HandiHaler, in Patients With Moderate-to-Severe COPD.
Phase of Trial: Phase III
Latest Information Update: 24 May 2017
At a glance
- Drugs Indacaterol (Primary) ; Tiotropium bromide
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Acronyms INTENSITY
- Sponsors Novartis
- 24 May 2017 Results (n=8445) of a pooled analysis from 11 Phase III/IIIb indacaterol studies assessing the efficacy and safety of once-daily indacaterol 150 and 300 ug in elderly patients with moderate to severe COPD, published in the Respiratory Medicine.
- 02 May 2016 Study is single blind in Italy as per EudraCT record. Other countries from EudraCT record and NCT source is reporting it as double blind.
- 24 Mar 2012 Planned number of patients changed from 1568 to 1600 as reported by European Clinical Trials Database record.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History