Phase 4
Completed N=581
Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)
Source: ClinicalTrials.gov NCT01555138 ↗Enrolled (actual)
581
Serious AEs
3.8%
Results posted
Apr 2015
Primary outcomePrimary: Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons — 1.591; 1.604 Liters
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons |
1.591; 1.604 | — |
| SECONDARY Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons |
1.567; 1.569 | — |
| SECONDARY FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons |
1.601; 1.588; 1.667; 1.656; 1.693; 1.684 | — |
| SECONDARY FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons |
1.569; 1.582; 1.670; 1.656; 1.676; 1.677 | — |
| SECONDARY FVC Over 26 Weeks of Treatment |
3.090; 3.064; 3.057; 3.062 | — |
| SECONDARY Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison |
1.689; 1.689; 1.683; 1.682 | — |
| SECONDARY TDI Focal Score at Week 12 and Week 26: Treatment Comparisons |
1.89; 1.69; 2.58; 2.70 | — |
| SECONDARY Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set) |
233; 215; 47; 57; 11; 15 | — |
| SECONDARY Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment |
1.82; 1.83; 1.50; 1.45; 1.37; 1.37 | — |
| SECONDARY Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use' |
52.8; 54.6 | — |
| SECONDARY St Georges Respiratory Questionnaire for COPD |
32.8; 32.9; 33.1; 33.5 | — |
Eligibility 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 preceding Visit 1.
Exclusion Criteria
- Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year.
- Having a history of, or current ECG abnormality
- Asthma
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01555138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.