Clinical trial NCT01682863: A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
Official title: A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 614
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: This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in 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
* Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Patients With Adverse Events, Serious Adverse Events, and Death
timeFrame: 56 weeks
Secondary outcomes:
measure: Time to Premature Discontinuation of Treatment
timeFrame: 56 weeks
measure: Change From Baseline in Pre-dose Trough FEV1
timeFrame: Day 29, 57,, 85, 141, 197, 253, 309 and 365
measure: Change From Baseline in 1 Hour Post-dose FEV1 Measurements
timeFrame: Day 1, 29, 57, 85, 141, 197, 253, 309, and 365
measure: Change From Baseline in FVC Measurement at All Post-baseline Time Points
timeFrame: Day1, 29, 57, 85, 141, 197, 253, 309, and 365
measure: Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation
timeFrame: 52 weeks
measure: Change From Baseline in Mean Total Daily Symptom Scores
timeFrame: 52 weeks
measure: Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Vestavia
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Huntington Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Lakewood
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Orange
country: United States
facility: Novartis Investigative Site
state: California
city: Stockton
country: United States
facility: Novartis Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigative Site
state: California
city: Boulder
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Honolulu
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Lombard
country: United States
facility: Novartis Investigative Site
state: Illinois
city: O'Fallon
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Peoria
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Ames
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Iowa City
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Waterloo
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Bowling Green
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Slidell
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Bangor
country: United States
facility: Novartis Investigative Site
state: Maine
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Livonia
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Picayune
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: St. Charles
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Missoula
country: United States
facility: Novartis Investigative Site
state: Montana
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Henderson
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Dayton
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Dublin
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Eugene
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Corsicana
country: United States
facility: Novartis Investigative Site
state: Texas
city: Ft. Worth
country: United States
facility: Novartis Investigative Site
state: Texas
city: Lufkin
country: United States
facility: Novartis Investigative Site
state: Texas
city: McKinney
country: United States
facility: Novartis Investigative Site
state: Texas
city: Abingdon
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Midlothian
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Newport News
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Ruse
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: HUS
country: Finland
facility: Novartis Investigative Site
city: Pori
country: Finland
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Mako
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szazhalombatta
country: Hungary
facility: Novartis Investigative Site
city: Szolnok
country: Hungary
facility: Novartis Investigative Site
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
city: Barceloneta
country: Puerto Rico
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 3
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 3
city: Constanta
country: Romania
facility: Novartis Investigative Site
state: Jud. Constanta
city: Iasi
country: Romania
facility: Novartis Investigative Site
state: Jud. Iasi
city: Brasov
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Cluj-Napoca
country: Romania
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Málaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Canet de Mar
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Centelles
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Tarragona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
Study officials:
References: