Clinical trial NCT01610037: Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
Official title: A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: chronic obstructive pulmonary disease
COPD
QVA149
QAB149
NVA237
Indacaterol maleate
Glycopyronnium bromide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 1215
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 study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.


Eligibility criteria: Inclusion criteria:

* Male and female adults aged ≥40 years.
* Patients with stable COPD according to GOLD strategy (GOLD 2011).
* Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and \<80% of the predicted normal, and a post-bronchodilator.
* FEV1/FVC \< 0.70.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients with an mMRC ≥ grade 2

Exclusion criteria:

* History of long QT syndrome or prolonged QTc.
* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
* Patients with Type I or uncontrolled Type II diabetes.
* Patients with a history of asthma or have concomitant pulmonary disease.
* Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible.
* Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety.

Primary outcomes:
measure: Number of Patients With Serious Adverse Events
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.
timeFrame: 52 weeks
measure: Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE
timeFrame: 52 weeks
measure: Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)
timeFrame: Day 22, 43, 85, 183, 274 and 364
measure: Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
timeFrame: Measurment at day 364
measure: Change From Baseline in Daily, Morning and Evening Symptom Scores
timeFrame: 52 weeks
measure: Change From Baseline in Percentage of Nights With 'no Nighttime Awakenings
timeFrame: 52 weeks
measure: Change From Baseline in Percentage of no Daytime Symptoms
timeFrame: 52 weeks
measure: Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.
timeFrame: 52 weeks
measure: Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements
timeFrame: Day 1, 22, 43, 85, 183, 274 and 364
measure: Time to Premature Discontinuation
timeFrame: Time varied from 5 - 407 days
measure: Change From Baseline in 1 Hour Post-dose FEV1 Measurements
timeFrame: Day 1, 22, 43, 85, 183, 274 and 364
Other outcomes:
Locations:
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: Florencio Varela
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Florida
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Lanus
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: San Isidro
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Vicente Lopez
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Concepcion del Uruguay
country: Argentina
facility: Novartis Investigative Site
state: Entre Rios
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
state: Rosario
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
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: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Corrientes
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: Santa Fe
country: Argentina
facility: Novartis Investigative Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Armenia
country: Colombia
facility: Novartis Investigative Site
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Osijek
country: Croatia
facility: Novartis Investigative Site
city: Sisak
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Cegled
country: Hungary
facility: Novartis Investigative Site
city: Csorna
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Eger
country: Hungary
facility: Novartis Investigative Site
city: Erd
country: Hungary
facility: Novartis Investigative Site
city: Godollo
country: Hungary
facility: Novartis Investigative Site
city: Monor
country: Hungary
facility: Novartis Investigative Site
city: Mosonmagyarovar
country: Hungary
facility: Novartis Investigative Site
city: Siofok
country: Hungary
facility: Novartis Investigative Site
city: Szarvas
country: Hungary
facility: Novartis Investigative Site
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: A.p.
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Panjim
country: India
facility: Novartis Investigative Site
state: Goa
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Mysore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Trivandrum
country: India
facility: Novartis Investigative Site
state: Kerala
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Bikaner
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Vellore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Ahmedabad
country: India
facility: Novartis Investigative Site
city: Nagpur - Maharashtra
country: India
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Bucheon-Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: León
country: Mexico
facility: Novartis Investigative Site
state: Guanajuato
city: Pachuca
country: Mexico
facility: Novartis Investigative Site
state: Hidalgo
city: Panama City
country: Panama
facility: Novartis Investigative Site
state: Panamá
city: Panama City
country: Panama
facility: Novartis Investigative Site
state: Panamá
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: N.Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Knez Selo
country: Serbia
facility: Novartis Investigative Site
city: Kragujevac
country: Serbia
facility: Novartis Investigative Site
city: Golnik
country: Slovenia
facility: Novartis Investigative Site
city: Kartal
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Pendik / Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigative Site
city: Leamington Spa
country: United Kingdom
facility: Novartis Investigative Site
state: Warwickshire
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Cheshire
country: United Kingdom
facility: Novartis Investigative Site
city: Doncaster
country: United Kingdom
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: Merseyside
country: United Kingdom
facility: Novartis Investigative Site
city: Newport
country: United Kingdom
facility: Novartis Investigative Site
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative Site
city: Wolverhampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: