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)

NCT01604278 | Completed Phase 3 Results

• 2 other identifiers: CNVA237A23162011-005673-23
• Study Type: interventional
• Target: 449
• Locations: 10 countries
• Sites: 80

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Indacaterol; Glycopyrronium Bromide; COPD; bronchodilation

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume at 1 Second (FEV1)

  Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.

  12 weeks

Secondary Outcomes (9)

• FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose

  12 weeks

• Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks

  12 weeks

• FEV1 at Individual Time-points

  Day 1, Day 29, Day 57 and Days 84/85

• Forced Vital Capacity (FVC) at Individual Time-points

  Day 1, Day 29, Day 57 and Days 84/85

• Inspiratory Capacity (IC) at Individual Time-points

  Day 1, Days 84/85

Study Arms (2)

NVA237 + indacaterol

ACTIVE COMPARATOR

Drug: NVA237 50 µg and indacaterol 150 µg

Placebo to NVA237 + indacaterol

PLACEBO COMPARATOR

Drug: Placebo to NVA237 and indacaterol 150 µg

Interventions

NVA237 50 µg and indacaterol 150 µg DRUG

NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.

Also known as: Glycopyrronium Bromide

NVA237 + indacaterol

Placebo to NVA237 and indacaterol 150 µg DRUG

Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.

Placebo to NVA237 + indacaterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (80)

Novartis Investigative Site

Malmedy/Bellevaux-Ligneuville, Belgium, 4960, Belgium

Location

Novartis Investigative Site

Luxembourg, Luxembourg, 1210, Belgium

Location

Novartis Investigative Site

Brussels, 1070, Belgium

Location

Novartis Investigative Site

Brussels, 1090, Belgium

Location

Novartis Investigative Site

Genk, 3600, Belgium

Location

Novartis Investigative Site

Gilly, 6060, Belgium

Location

Novartis Investigative Site

Gosselies, 6041, Belgium

Location

Novartis Investigative Site

Hasselt, 3500, Belgium

Location

Novartis Investigative Site

Herentals, 2200, Belgium

Location

Novartis Investigative Site

Jambes, 5100, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Montigny-le-Tilleul, 6110, Belgium

Location

Novartis Investigative Site

Turnhout, 2300, Belgium

Location

Novartis Investigative Site

Yvoir, 5530, Belgium

Location

Novartis Investigative Site

Rousse, Bulgaria, 7002, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1000, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1431, Bulgaria

Location

Novartis Investigative Site

Sofia, Bulgaria, 1606, Bulgaria

Location

Novartis Investigative Site

Varna, Bulgaria, 9010, Bulgaria

Location

Novartis Investigative Site

Pleven, 5800, Bulgaria

Location

Novartis Investigative Site

Plovdiv, 4002, Bulgaria

Location

Novartis Investigative Site

Stara Zagora, 6000, Bulgaria

Location

Novartis Investigative Site

Athens, Greece, 11527, Greece

Location

Novartis Investigative Site

Athens, GR, 106 76, Greece

Location

Novartis Investigative Site

Athens, GR, 115 27, Greece

Location

Novartis Investigative Site

Thessaloniki, GR, 564 03, Greece

Location

Novartis Investigative Site

Érd, Hungary, H-2030, Hungary

Location

Novartis Investigative Site

Budapest, 1046, Hungary

Location

Novartis Investigative Site

Budapest, 1121, Hungary

Location

Novartis Investigative Site

Deszk, 6772, Hungary

Location

Novartis Investigative Site

Gödöllő, 2100, Hungary

Location

Novartis Investigative Site

Wilton, Cork, Ireland

Location

Novartis Investigative Site

Moscow, 125315, Russia

Location

Novartis Investigative Site

N.Novgorod, 603126, Russia

Location

Novartis Investigative Site

Nizhny Novgorod, 603018, Russia

Location

Novartis Investigative Site

Saratov, 410012, Russia

Location

Novartis Investigative Site

Bardejov, Slovak Republic, 085 01, Slovakia

Location

Novartis Investigative Site

Bojnice, Slovak Republic, 972 01, Slovakia

Location

Novartis Investigative Site

Liptovský Hrádok, Slovak Republic, 033 01, Slovakia

Location

Novartis Investigative Site

Kráľovský Chlmec, Slovakia, 077 01, Slovakia

Location

Novartis Investigative Site

Námestovo, Slovensko, 02901, Slovakia

Location

Novartis Investigative Site

Bratislava, 826 06, Slovakia

Location

Novartis Investigative Site

Košice, 040 01, Slovakia

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

Location

Novartis Investigative Site

Barcelona, Barcelona, 08025, Spain

Location

Novartis Investigative Site

Torrelavega, Cantabria, 39300, Spain

Location

Novartis Investigative Site

Ponferrada, Castille and León, 24400, Spain

Location

Novartis Investigative Site

Illescas, Castille-La Mancha, 45200, Spain

Location

Novartis Investigative Site

Centelles, Catalonia, 08540, Spain

Location

Novartis Investigative Site

Salt, Catalonia, 17190, Spain

Location

Novartis Investigative Site

Sant Boi de Llobregat, Catalonia, 08830, Spain

Location

Novartis Investigative Site

Viladecans, Catalonia, Spain

Location

Novartis Investigative Site

Mérida, Extremadura, 06800, Spain

Location

Novartis Investigative Site

Gijón, Principality of Asturias, 33290, Spain

Location

Novartis Investigative Site

Ankara, Turkey, 06490, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34854, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, Turkey (Türkiye)

Location

Novartis Investigative Site

Kocaeli, 41380, Turkey (Türkiye)

Location

Novartis Investigative Site

Mersin, 33079, Turkey (Türkiye)

Location

Novartis Investigative Site

Yenisehir/Izmir, 35110, Turkey (Türkiye)

Location

Novartis Investigative Site

Burnhope, County Durham, DH7 0BD, United Kingdom

Location

Novartis Investigative Site

Newcastle upon Tyne, Newcastle-upon-Tyne, NE7 7DN, United Kingdom

Location

Novartis Investigative Site

Alderton, Suffolk, IP12 3DA, United Kingdom

Location

Novartis Investigative Site

Cambridge, United KIngdom, CB7 5JD, United Kingdom

Location

Novartis Investigative Site

Watford, United Kingdom, WD25 0EA, United Kingdom

Location

Novartis Investigative Site

Atherstone, Warwickshire, CV9 1EU, United Kingdom

Location

Novartis Investigative Site

Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom

Location

Novartis Investigative Site

Strensall, Yorkshire, YO32 5UA, United Kingdom

Location

Novartis Investigative Site

Bath, BA1 2SR, United Kingdom

Location

Novartis Investigative Site

Bexhill-on-Sea, TN40 1JJ, United Kingdom

Location

Novartis Investigative Site

Blackpool, FY3 7EN, United Kingdom

Location

Novartis Investigative Site

Bradford, BD9 6RJ, United Kingdom

Location

Novartis Investigative Site

Chesterfield, S40 4AA, United Kingdom

Location

Novartis Investigative Site

Huntingdon, PE29 6NT, United Kingdom

Location

Novartis Investigative Site

Manchester, M20 2RN, United Kingdom

Location

Novartis Investigative Site

Newton Aycliffe, DL5 4SE, United Kingdom

Location

Novartis Investigative Site

Reading, RG7 3SQ, United Kingdom

Location

Novartis Investigative Site

Southbourne, United Kingdom

Location

Novartis Investigative Site

Telford, TF1 6TF, United Kingdom

Location

Novartis Investigative Site

Wiltshire, SN15 2SB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24596459 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate; indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 14, 2014
• Results First Posted: November 14, 2014

Record last verified: 2014-11

Locations

RU (4); GR (4); HU (5); TU (6); BU (8); ES (11); IE (1); BE (14); SL (7); GB (20)