Clinical trial NCT02371629: A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD
Official title: A Randomized, Double-blind, Parallel Group, 26-week Study Evaluating the Efficacy, Safety and Tolerability of NVA237 Given Once or Twice Daily, in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Anticholinergic
Antimuscarinic
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Chronic Obstructive Pulmonary Disease
COPD
LAMA
Lung Disease
Lung Diseases, Obstructive
Lung Function
Muscarinic receptor antagonist
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-02-25
Enrollment: 776
Sex: ALL
Minimum age (years): 41
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a post-authorization commitment to the European Medicines Agency (EMA). The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug was tested for twice daily dosing against once daily dosing.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Male and female adults aged ≥40 years
* Patients with stable COPD according to the current GOLD strategy (GOLD 2014)
* Current or ex-smokers who have a smoking history of at least 10 pack years- an ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening
* mMRC grade of at least 2 at Visit 101
* 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 at Visit 101.

Exclusion Criteria:

* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test; Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
* Patients with Type I or uncontrolled Type II diabetes; Patients with a history of long QT syndrome or whose QTc measured at run-in (Fridericia method) is prolonged (\>450 ms for males and \>460 for females) and confirmed by a central assessor
* Patients requiring long term oxygen therapy prescribed for \>12 h per day; Patients with any history of asthma.

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 12
timeFrame: Baseline, 0-12 hour, 0-24 hour , 12-24 hour post dose at Week 12
measure: Change From Baseline in Area Under The Curve (AUC 0-12 Hour) for Forced Expiratory Volume in One Second (FEV1) Post Dosing at Day 1
timeFrame: Baseline, 0-12 hour post dose at Day 1
measure: Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 26
timeFrame: Baseline, 0-12 hour, 0-24 hour , 12-24 hour post dose at Week 26
measure: Change From Baseline in Total St. George's Respiratory Questionnaire (SGRQ) Score at Week 12 and Week 26
timeFrame: Baseline, 12 Weeks, 26 Weeks
measure: Percentage of Patients With a Clinically Significant Improvement in St George Respiratory Questionnaire at Week 12 and Week 26
timeFrame: Baseline, 12 Weeks, 26 Weeks
measure: Change From Baseline in Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26
timeFrame: Baseline, 12 Weeks, 26 Weeks
measure: Percentage of Patients With a Clinically Important Improvement on Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26
timeFrame: Baseline, 12 Weeks, 26 Weeks
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 26
timeFrame: Baseline, Day 1, Week 26
measure: Change From Baseline in Forced Vital Capacity (FVC) at Individual Timepoints at Week 26
timeFrame: Baseline, Week 26 (Day 183-184)
measure: Change From Baseline in Inspiratory Capacity (IC) at Individual Timepoints at Week 26
timeFrame: Baseline, Week 26 (Day 183-184)
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Individual Timepoints at Week 26
timeFrame: Baseline, Week 26 (Day 183-184)
measure: Change From Baseline in the Percentage of Days With no Rescue Medication Use Over the 26 Weeks
timeFrame: Baseline, 26 Weeks
measure: Change From Baseline in Mean Daily COPD Symptom Score at Week 26
timeFrame: Baseline, 26 Weeks
measure: Number of Patients With Adverse Events, Serious Adverse Events and Death
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Novartis Investigative Site
state: Limburg
city: Jambes
country: Belgium
facility: Novartis Investigative Site
state: Namur
city: Sevlievo
country: Bulgaria
facility: Novartis Investigative Site
state: Gabrovo
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
state: Sofia-Grad
city: Gabrovo
country: Bulgaria
facility: Novartis Investigative Site
city: Kozloduj
country: Bulgaria
facility: Novartis Investigative Site
city: Lom
country: Bulgaria
facility: Novartis Investigative Site
city: Lovech
country: Bulgaria
facility: Novartis Investigative Site
city: Montana
country: Bulgaria
facility: Novartis Investigative Site
city: Razgrad
country: Bulgaria
facility: Novartis Investigative Site
city: Roman
country: Bulgaria
facility: Novartis Investigative Site
city: Ruse
country: Bulgaria
facility: Novartis Investigative Site
city: Silistra
country: Bulgaria
facility: Novartis Investigative Site
city: Sliven
country: Bulgaria
facility: Novartis Investigative Site
city: Smolyan
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: Troyan
country: Bulgaria
facility: Novartis Investigative Site
city: Veliko Tarnovo
country: Bulgaria
facility: Novartis Investigative Site
city: Vidin
country: Bulgaria
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
state: Baden-Württemberg
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Koblenz
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Großhansdorf
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Greifswald
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Schwerin
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Balassagyarmat
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Farkasgyepu
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Sopron
country: Hungary
facility: Novartis Investigative Site
city: Szarvas
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Novartis Investigative Site
state: Lódzkie
city: Tarnow
country: Poland
facility: Novartis Investigative Site
state: Malopolskie
city: Chorzow
country: Poland
facility: Novartis Investigative Site
state: Slaskie
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Kielce
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Sopot
country: Poland
facility: Novartis Investigative Site
city: Wilkowice
country: Poland
facility: Novartis Investigative Site
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Dolj
city: Constanta
country: Romania
facility: Novartis Investigative Site
state: Jud. Constanta
city: Tg Mures
country: Romania
facility: Novartis Investigative Site
state: Mures
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Baia Mare
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: Cluj-Napoca
country: Romania
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
state: Tatarstan Republic
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Izhevsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
country: Russian Federation
facility: Novartis Investigative Site
city: Kemerovo
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: Sestroretsk
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
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: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Linkoping
country: Sweden
facility: Novartis Investigative Site
state: Ostergotlands Lan
city: Malmo
country: Sweden
facility: Novartis Investigative Site
state: Skane Lan
city: Lidingo
country: Sweden
facility: Novartis Investigative Site
state: Sodermanlands Lan
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
state: Vastra Gotalands Lan
city: Lund
country: Sweden
facility: Novartis Investigative Site
Study officials:
References: