Clinical trial NCT01860066: A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD
Official title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in COPD Patients With Moderate to Severe Airflow Limitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation.


Eligibility criteria: Inclusion Criteria: - Age \>= 40 years, patients with airflow limitation indicated by post-bronchdilation FEV1 \>=30% and \<80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mMRC grade 2 or greater Exclusion Criteria: - prolonged QTCF \>450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment
timeFrame: Day 1 and Week 12
measure: Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose
timeFrame: Day 1 and Week 12
measure: Area under the curve (AUC) 0-4 hours for FEV1
timeFrame: Day 1 and Week 12
measure: Transition Dyspnea Index (TDI) Focal Score
timeFrame: Week 12
measure: Quality of Lfe Assessment with St George's Respiratory Questionaire (SGRQ)
timeFrame: Week 12
measure: Change from baseline in daily number of puffs of rescue medication
timeFrame: Week 12
measure: Daily symptoms reported by patient
timeFrame: Week 12
measure: COPD assessment (CAT) test
timeFrame: Week 12
measure: Safety and tolerability
timeFrame: Over 12 weeks
Other outcomes:
Locations:
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: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Genk
country: Belgium
facility: Novartis Investigative Site
city: Gilly
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Jambes
country: Belgium
facility: Novartis Investigative Site
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Florida Blanca
country: Colombia
facility: Novartis Investigative Site
city: Medellín
country: Colombia
facility: Novartis Investigative Site
city: Kyjov
country: Czech Republic
facility: Novartis Investigative Site
state: CZE
city: Cvikov
country: Czech Republic
facility: Novartis Investigative Site
city: Jindrichuv Hradec
country: Czech Republic
facility: Novartis Investigative Site
city: Karlovy Vary
country: Czech Republic
facility: Novartis Investigative Site
city: Kurim
country: Czech Republic
facility: Novartis Investigative Site
city: Pardubice
country: Czech Republic
facility: Novartis Investigative Site
city: Teplice
country: Czech Republic
facility: Novartis Investigative Site
city: Guntur
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Faridabad
country: India
facility: Novartis Investigative Site
state: Haryana
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Karamsad
country: India
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: