Clinical trial NCT01604278: Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: A 12-week Multi-center, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of the Co-administration of NVA237 + Indacaterol Once Daily vs. Indacaterol Once Daily in Patients With Moderate to Severe COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Indacaterol
Glycopyrronium Bromide
COPD
bronchodilation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-23
Enrollment: 449
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 assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
* Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or \<80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) \< 0.70 at screening.
* Current or ex-smokers who have a smoking history of at least 10 pack years
* Symptomatic patients according to daily diary data.

Exclusion Criteria:

* Pregnant or nursing (lactating) women.
* Women of child-bearing potential unless using adequate contraception.
* Patients with Type I or uncontrolled Type II diabetes.
* Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
* Patients with paroxysmal (e.g. intermittent) atrial fibrillation
* Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Trough Forced Expiratory Volume at 1 Second (FEV1)
timeFrame: 12 weeks
Secondary outcomes:
measure: FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
timeFrame: 12 weeks
measure: Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks
timeFrame: 12 weeks
measure: FEV1 at Individual Time-points
timeFrame: Day 1, Day 29, Day 57 and Days 84/85
measure: Forced Vital Capacity (FVC) at Individual Time-points
timeFrame: Day 1, Day 29, Day 57 and Days 84/85
measure: Inspiratory Capacity (IC) at Individual Time-points
timeFrame: Day 1, Days 84/85
measure: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
timeFrame: Baseline, 12 weeks
measure: Transitional Dyspnea Index (TDI) Focal Score
timeFrame: baseline, 12 weeks
measure: Change From Baseline in Mean Daily Total and Individual Symptom Scores
timeFrame: Baseline, 12 weeks
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brussel
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: Gosselies
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Herentals
country: Belgium
facility: Novartis Investigative Site
city: Jambes
country: Belgium
facility: Novartis Investigative Site
city: Liège
country: Belgium
facility: Novartis Investigative Site
city: Luxembourg
country: Belgium
facility: Novartis Investigative Site
city: Malmedy/Bellevaux-Ligneuville
country: Belgium
facility: Novartis Investigative Site
city: Montigny-le-tilleul
country: Belgium
facility: Novartis Investigative Site
city: Turnhout
country: Belgium
facility: Novartis Investigative Site
city: Yvoir
country: Belgium
facility: Novartis Investigative Site
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: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Deszk
country: Hungary
facility: Novartis Investigative Site
city: Erd
country: Hungary
facility: Novartis Investigative Site
city: Godollo
country: Hungary
facility: Novartis Investigative Site
city: Wilton
country: Ireland
facility: Novartis Investigative Site
state: Cork
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: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Liptovsky Hradok
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Námestovo
country: Slovakia
facility: Novartis Investigative Site
state: Slovensko
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Kralovsky Chlmec
country: Slovakia
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Gijon
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Torrelavega
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Illescas
country: Spain
facility: Novartis Investigative Site
state: Castilla la Mancha
city: Ponferrada
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Centelles
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Salt
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Sant Boi de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Viladecans
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Mérida
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigative Site
city: Burnhope
country: United Kingdom
facility: Novartis Investigative Site
state: County Durham
city: Alderton
country: United Kingdom
facility: Novartis Investigative Site
state: Suffolk
city: Atherstone
country: United Kingdom
facility: Novartis Investigative Site
state: Warwickshire
city: Leamington Spa
country: United Kingdom
facility: Novartis Investigative Site
state: Warwickshire
city: Strensall
country: United Kingdom
facility: Novartis Investigative Site
state: Yorkshire
city: Bath
country: United Kingdom
facility: Novartis Investigative Site
city: Bexhill-on-Sea
country: United Kingdom
facility: Novartis Investigative Site
city: Blackpool
country: United Kingdom
facility: Novartis Investigative Site
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
city: Chesterfield
country: United Kingdom
facility: Novartis Investigative Site
city: Huntingdon
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Newton Aycliffe
country: United Kingdom
facility: Novartis Investigative Site
city: Reading
country: United Kingdom
facility: Novartis Investigative Site
city: Southbourne
country: United Kingdom
facility: Novartis Investigative Site
city: Telford
country: United Kingdom
facility: Novartis Investigative Site
city: Watford
country: United Kingdom
facility: Novartis Investigative Site
city: Wiltshire
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Vincken W, Aumann J, Chen H, Henley M, McBryan D, Goyal P. Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study. Int J Chron Obstruct Pulmon Dis. 2014 Feb 24;9:215-28. doi: 10.2147/COPD.S51592. eCollection 2014.