Clinical trial NCT01555138: Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Indacaterol
Salmeterol/fluticasone propionate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 581
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons
timeFrame: 12 weeks
Secondary outcomes:
measure: Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons
timeFrame: 26 weeks
measure: FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
timeFrame: 12 weeks
measure: FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
timeFrame: 26 weeks
measure: FVC Over 26 Weeks of Treatment
timeFrame: 12 and 26 weeks
measure: Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison
timeFrame: 12 and 26 weeks
measure: TDI Focal Score at Week 12 and Week 26: Treatment Comparisons
timeFrame: 12 and 26 weeks
measure: Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
timeFrame: 26 weeks
measure: Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment
timeFrame: 12 and 26 weeks
measure: Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'
timeFrame: 26 weeks
measure: St Georges Respiratory Questionnaire for COPD
timeFrame: 12 and 26 weeks
Other outcomes:
Locations:
city: C A B A
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Villa María
country: Argentina
facility: Novartis Investigative Site
state: Córdoba
city: Concepción del Uruguay
country: Argentina
facility: Novartis Investigative Site
state: Entre Ríos
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
state: Rosario
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Caba
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Salta
country: Argentina
facility: Novartis Investigative Site
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Acquaviva delle Fonti
country: Italy
facility: Novartis Investigative Site
state: BA
city: Cassano delle Murge
country: Italy
facility: Novartis Investigative Site
state: BA
city: Treviglio
country: Italy
facility: Novartis Investigative Site
state: BG
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Caserta
country: Italy
facility: Novartis Investigative Site
state: CE
city: Forlì
country: Italy
facility: Novartis Investigative Site
state: FC
city: Cona
country: Italy
facility: Novartis Investigative Site
state: FE
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: FG
city: Cassino
country: Italy
facility: Novartis Investigative Site
state: FR
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Sesto San Giovanni
country: Italy
facility: Novartis Investigative Site
state: Mi
city: Cittadella
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Pordenone
country: Italy
facility: Novartis Investigative Site
state: PN
city: Parma
country: Italy
facility: Novartis Investigative Site
state: PR
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Salerno
country: Italy
facility: Novartis Investigative Site
state: SA
city: Cuasso al Monte
country: Italy
facility: Novartis Investigative Site
state: VA
city: Tradate
country: Italy
facility: Novartis Investigative Site
state: VA
city: Negrar
country: Italy
facility: Novartis Investigative Site
state: VR
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Wilayah Persekutuan
country: Malaysia
facility: Novartis Investigative Site
state: Kuala Lumpur
city: Kuching
country: Malaysia
facility: Novartis Investigative Site
state: Sarawak
city: Pulau Pinang
country: Malaysia
facility: Novartis Investigative Site
city: Ciudad De Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo León
city: Querétaro
country: Mexico
facility: Novartis Investigative Site
city: San Luis Potosi
country: Mexico
facility: Novartis Investigative Site
city: Breda
country: Netherlands
facility: Novartis Investigative Site
city: Helmond
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Loja
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sanlúcar de Barrameda
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Canet de Mar
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Corbera de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Lerida
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Pozuelo de Alarcón
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Biel
country: Switzerland
facility: Novartis Investigative Site
city: Gossau
country: Switzerland
facility: Novartis Investigative Site
city: Muenchenstein
country: Switzerland
facility: Novartis Investigative Site
city: Dundee
country: United Kingdom
facility: Novartis Investigative Site
state: Perthshire
city: Hants
country: United Kingdom
facility: Novartis Investigative Site
state: Southampton
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
city: Chester
country: United Kingdom
facility: Novartis Investigative Site
city: East Yorkshire
country: United Kingdom
facility: Novartis Investigative Site
city: Kettering
country: United Kingdom
facility: Novartis Investigative Site
city: Lancaster
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Surrey
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: