A Randomized, Double-blind, Parallel-group, 26-week Study Comparing the Efficacy and Safety of Indacaterol (Onbrez® Breezhaler® 150 mcg o.d.) With Salmeterol/Fluticasone Propionate (Seretide® Accuhaler® 50 mcg/500 mcg b.i.d.) in Patients With Moderate Chronic Obstructive Pulmonary Disease (INSTEAD)

NCT01555138 Phase 4 COMPLETED Results posted

The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 4
Status	COMPLETED
Enrolment	581
Start date	2012-02
Completion	2014-02

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

• Indacaterol
• Salmeterol

Primary outcomes

• Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons — 12 weeks
  Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.

Countries

Argentina, Colombia, Italy, Malaysia, Mexico, Netherlands, Spain, Switzerland, United Kingdom