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)

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005673-23-HU

Enrollment

450

Registered

2012-02-24

Start date

2012-04-18

Completion date

Unknown

Last updated

2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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: NV

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 225

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 ;Primary end point(s): 24 h trough forced expiratory volume in 1 second (FEV1) after 12 weeks.;Timepoint(s) of evaluation of this end point: Timeframe: 12 Weeks	—

Measure

Time frame

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 ;Primary end point(s): 24 h trough forced expiratory volume in 1 second (FEV1) after 12 weeks.;Timepoint(s) of evaluation of this end point: Timeframe: 12 Weeks

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Secondary

Measure	Time frame
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;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	—

Measure

Time frame

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;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

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Countries

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

Contacts

Public ContactPublic Information Desk

Novartis Hungária Kft., Pharma

infoph.hungary@novartis.com+361457-6500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026