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.

A randomized, double-blind, parallel-group, 26-week study comparing the efficacy and safety of indacaterol (Onbrez® Breezhaler® 150 µg o.d.) with salmeterol/fluticasone propionate (Seretide® Accuhaler® 50 µg/500 µg b.i.d.) in patients with moderate chronic obstructive pulmonary disease.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003732-31-GB

Enrollment

600

Registered

2011-12-21

Start date

2012-01-23

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Onbrez Breezhaler Pharmaceutical Form: Inhalation powder, hard capsule CAS Number: 753498-25-8 Current Sponsor code: QAB149

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with moderate COPD (Stage II) - Able to perform spirometry assessments - Current or ex-smokers - On treatment with the fixed-dose combination of salmeterol 50 µg /fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for =3 months directly Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

Exclusion criteria: - Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year. - A history of, or current ECG abnormality. - Asthma Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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; Secondary Objective: To evaluate the effect of indacaterol 150 µg o.d. as compared to salmeterol 50 µg / fluticasone propionate 500 µg b.i.d. on trough FEV1, standardized FEV1 AUC5 min-4 h, FEV and FVC, Transition Dyspnea Index (TDI), St George’s Respiratory Questionnaire for COPD Patients (SGRQ-C), rescue medication use, safety and exacerbations over the 26 week treatment period. ; Primary end point(s): To demonstrate non-inferiority of indacaterol (150 µg o.d.) versus salmeterol 50 µg /fluticasone propionate 500 µg b.i.d. with respect to trough FEV1 after 12 weeks of treatment in patients with moderate COPD. Trough FEV1 is the mean of the values assessed at 23 h 10 min and 23 h 45 min following the morning dose after 12 weeks of dosing. ;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: 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; Secondary Objective: To evaluate the effect of indacaterol 150 µg o.d. as compared to salmeterol 50 µg / fluticasone propionate 500 µg b.i.d. on trough FEV1, standardized FEV1 AUC5 min-4 h, FEV and FVC, Transition Dyspnea Index (TDI), St George’s Respiratory Questionnaire for COPD Patients (SGRQ-C), rescue medication use, safety and exacerbations over the 26 week treatment period. ; Primary end point(s): To demonstrate non-inferiority of indacaterol (150 µg o.d.) versus salmeterol 50 µg /fluticasone propionate 500 µg b.i.d. with respect to trough FEV1 after 12 weeks of treatment in patients with moderate COPD. Trough FEV1 is the mean of the values assessed at 23 h 10 min and 23 h 45 min following the morning dose after 12 weeks of dosing. ;Timepoint(s) of evaluation of this end point: 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Trough FEV1 is mean of the values assessed at 23 h 10 min and 23 h 45 min following the morning dose after 26 weeks of dosing.;Timepoint(s) of evaluation of this end point: 26 weeks	—

Countries

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

Contacts

Public ContactMedical Information Services

Novartis Pharmaceuticals UK Ltd

medinfo.uk@novartis.com4401276698370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026