Trial intelligence / Profile preview

Indacaterol vs Placebo and Tiotropium in Maintenance Naïve COPD

NCT01715311Phase 4

Key facts

Status: Withdrawn
Start: Nov 2012
Primary completion: Sep 2013
Sponsor: Novartis
Modality: Small Molecules

Drugs: indacaterol
Conditions: chronic obstructive pulmonary disease (COPD)

Overview

Phase 4, randomised, double-blind trial of indacaterol in chronic obstructive pulmonary disease (COPD) (3 arms), sponsored by Novartis. Primary endpoint: Efficacy comparison of indacaterol to placebo at 12 weeks. Planned start Nov 2012; status: withdrawn.

Design

3 arms

Study design: RandomizedDouble-blind

Indacaterol
Indacaterol once daily
Placebo
Placebo (rescue medication only)
Tiotropium
Tiotropium once daily

Who it enrols

Maintenance-naïve patients with stable COPD (GOLD 2011 Groups A or B), aged 40 or older (implied by symptom onset exclusion), with at least 10 pack-years smoking history, FEV1 50-80% predicted, and FEV1/FVC < 0.7.

Endpoints

Primary

Efficacy comparison of indacaterol to placebo12 weeks

Secondary

St George's Respiratory Questionnaire for COPD (SGRQ-C) total score comparison12 weeks
Comparison of Forced Expiratory Volume in one second12 weeks
Adverse events and serious adverse events12 weeks

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