Efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

• Register: EUCTR
• Last refreshed on: 9 March 2015
• Main ID: EUCTR2011-005673-23-IE
• Date of registration: 10/04/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Service AG
• Public title: Efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
• Scientific 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 - GLOW6
• Date of first enrolment: 01/06/2012
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005673-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Belgium, Bulgaria, Greece, Hungary, Ireland, Russian Federation, Spain, Turkey, United Kingdom

Contacts

• Name: Bridget Cunningham
• Affiliation: Novartis Ireland Limited

• Name: Bridget Cunningham
• Affiliation: Novartis Ireland Limited

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients with moderate to severe stable COPD (Stage II or Stage III) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
2. Patients with a post-bronchodilator FEV1 = 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at screening.
3. Current or ex-smokers who have a smoking history of at least 10 pack years
4. Symptomatic patients according to daily diary data.

Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion criteria:
1. Pregnant or nursing (lactating) women.
2. Women of child-bearing potential.
3. Patients with Type I or uncontrolled Type II diabetes.
4. 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 method) is prolonged
5. Patients with paroxysmal (e.g. intermittent) atrial fibrillation
6. Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol defined exclusion criteria may apply


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Name: Glycopyrronium bromide
Product Code: NVA237
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596-51-0
Current Sponsor code: NVA237
Other descriptive name: Glycopyrronium Bromide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Primary end point(s): 24 h trough forced expiratory volume in 1 second (FEV1) after 12 weeks.

Main Objective: To demonstrate the superiority of NVA237 50 µg + indacaterol 150 µg administered once daily as compared with indacaterol 150 µg administered once daily in terms of trough FEV1 at Week 12.

Secondary Objective: To evaluate the effect of NVA237 50 µg o.d. + indacaterol 150 µg o.d. as compared to indacaterol 150 µg o.d. in terms of:
•FEV1 AUC5 min – 4 h post dosing at Week 12
•Peak FEV1 at Week 12 (where peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing)
•FEV1, FVC and IC at individual time-points on Day 1, Day 29, Day 57 and Days 84/85
•The mean change from baseline in daily number of puffs of rescue medication following 12 weeks of treatment
•The focal score of the Transitional Dyspnea Index (TDI) after 12 weeks of treatment
•Symptoms reported over 12 weeks of treatment using e-diary
•Safety and tolerability

Timepoint(s) of evaluation of this end point: Timeframe: 12 Weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: a. b. Timeframe: 12 Weeks
c. d. e. Timeframe: Day 1, Day 29, Day 57 and Days 84/85
f. Timeframe: Baseline and 12 weeks
g. h. i. Timeframe: 12 weeks

Secondary end point(s): a. Post dose FEV1 Area Under the Curve (AUC)5 min – 4 h
b. Peak FEV1
c. FEV1 at individual time-points
d. Forced Vital Capacity (FVC) at individual time-points
e. Inspiratory capacity (IC) at individual time-points
f. Mean change from baseline in daily number of puffs of rescue medication
g. Focal score of the Transitional Dyspnea Index (TDI)
h. Symptoms via patient e-diary
i. Safety and tolerability

Secondary ID(s)

2011-005673-23-HU

CNVA237A2316

Source(s) of Monetary Support

Novartis Pharma Service AG