Clinical trial NCT02449018: A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251
Official title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Doses of QBW251 in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Keywords: COPD,
chronic bronchitis,
inflammation,
airway,
LCI,
pulmonary function test,
lung function,
controlled clinical trial,
randomized,
airflow,
smoker
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-05-20
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)


Eligibility criteria: Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonary disease (COPD); Must have clinical diagnosis of chronic bronchitis; Must be either a current smoker (smoked ≤ 1 pack per day on average for the last 3 months with at least a 10 pack year smoking history) OR an ex-smoker with at least a 10 pack year smoking history; Exclusion Criteria: Must not be receiving chronic, daily, systemic steroids; Must not have severe emphysema (determined by HRCT); Must not have had a COPD exacerbation or respiratory tract infection requiring antibiotics or oral steroids or hospitalization within 6 weeks of screening; Must not be pregnant or nursing or a woman of child bearing potential; Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Lung Clearance Index (LCI)
timeFrame: Baseline and Day 29
Secondary outcomes:
measure: Change From Baseline in FEV1 Pre-bronchodilator
timeFrame: Day 29
measure: Change From Baseline in FEV1 Post-bronchodilator
timeFrame: Day 29
measure: Change From Baseline in FVC Pre Bronchodilator
timeFrame: Day 29
measure: Change From Baseline in FVC Post- Bronchodilator
timeFrame: Day 29
measure: Change From Baseline in TLC
timeFrame: Day 29
measure: Change From Baseline in RV
timeFrame: Day 29
measure: Change From Baseline in FRC
timeFrame: Day 29
measure: Change From Baseline in DLCO
timeFrame: Day 29
measure: Plasma Concentration of QBW251 by TMax (0-8hours)
timeFrame: Day 1, Day 28
measure: Plasma Concentration of QBW251 by CMax (0-8hours)
timeFrame: Day 1, Day 28
measure: Plasma Concentration of QBW251 by AUClast (0-8hours)
timeFrame: Day 1, Day 28
measure: Plasma Concentration of QBW251 by AUC0-12h
timeFrame: Day 1, Day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Fullerton
country: United States
facility: Novartis Investigative Site
state: California
city: Waterbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Port Orange
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: Normal
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Huntersville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Shelby
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Simpsonville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Union
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Sobotka
country: Poland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: