A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

NCT01682863 | Completed Phase 3 Results DMC

• 2 other identifiers: CQVA149A23402012-001998-93
• Study Type: interventional
• Target: 614
• Locations: 7 countries
• Sites: 86

Brief Summary

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events, Serious Adverse Events, and Death

  The overall rate of adverse events reported from initiation through 30 days post last dose.

  56 weeks

Secondary Outcomes (7)

• Time to Premature Discontinuation of Treatment

  56 weeks

• Change From Baseline in Pre-dose Trough FEV1

  Day 29, 57,, 85, 141, 197, 253, 309 and 365

• Change From Baseline in 1 Hour Post-dose FEV1 Measurements

  Day 1, 29, 57, 85, 141, 197, 253, 309, and 365

• Change From Baseline in FVC Measurement at All Post-baseline Time Points

  Day1, 29, 57, 85, 141, 197, 253, 309, and 365

• Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation

  52 weeks

Study Arms (3)

QVA149 dose 1

EXPERIMENTAL

QVA149 27.5/12.5 μg capsules

Drug: QVA149

QVA149 dose 2

EXPERIMENTAL

QVA149 27.5/25 μg capsules

Drug: QVA149

QAB149

ACTIVE COMPARATOR

QAB149 75 μg capsules

Drug: QAB149; Drug: Placebo

Interventions

QVA149 DRUG

QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI

QVA149 dose 1

QAB149 DRUG

QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI

QAB149

Placebo DRUG

To mimic QAB149

QAB149

Eligibility Criteria

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

You may qualify if:

• Male and female adults aged ≥40 years
• Patients with stable COPD according to GOLD strategy (GOLD 2011).
• 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.
• Current or ex-smokers who have a smoking history of at least 10 pack years.
• Patients with an mMRC ≥ grade 2

You may not qualify if:

• History of long QT syndrome or prolonged QTc
• Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
• Patients with Type I or uncontrolled Type II diabetes
• Patients with a history of asthma or have concomitant pulmonary disease
• Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
• Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (86)

Novartis Investigative Site

Vestavia Hills, Alabama, 35216, United States

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Huntington Beach, California, 92647, United States

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Lakewood, California, 90712-151, United States

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Los Angeles, California, 90048, United States

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Orange, California, 92868, United States

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Stockton, California, 95207, United States

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Walnut Creek, California, 94598, United States

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Boulder, Colorado, 80304, United States

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Honolulu, Hawaii, 96814, United States

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Lombard, Illinois, 60148, United States

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O'Fallon, Illinois, 62269, United States

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Peoria, Illinois, 61602, United States

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Evansville, Indiana, 47712, United States

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Ames, Iowa, 50010, United States

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Iowa City, Iowa, 52240, United States

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Waterloo, Iowa, 50702, United States

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Bowling Green, Kentucky, 42101, United States

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New Orleans, Louisiana, 70115, United States

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Slidell, Louisiana, 70458, United States

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Bangor, Maine, 04401, United States

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Baltimore, Maryland, 21224, United States

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Livonia, Michigan, 48152, United States

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Minneapolis, Minnesota, 55407, United States

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Jackson, Mississippi, 39209, United States

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Picayune, Mississippi, 39466, United States

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Saint Charles, Missouri, 63301, United States

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Missoula, Montana, 59804, United States

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Lincoln, Nebraska, 68506, United States

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Omaha, Nebraska, 68131, United States

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Henderson, Nevada, 89014, United States

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Las Vegas, Nevada, 89119, United States

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Rochester, New York, 14618, United States

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Dayton, Ohio, 45459, United States

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Dublin, Ohio, 43016, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, United States

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Eugene, Oregon, 97404, United States

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Medford, Oregon, 97504-8741, United States

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Spartanburg, South Carolina, 29303, United States

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Knoxville, Tennessee, 37912, United States

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Corsicana, Texas, 75110, United States

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Fort Worth, Texas, 76104, United States

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Lufkin, Texas, 75904, United States

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McKinney, Texas, 75069, United States

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Abingdon, Virginia, 24210, United States

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Midlothian, Virginia, 23114, United States

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Newport News, Virginia, 23606, United States

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Rousse, Bulgaria, 7002, Bulgaria

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Sofia, Bulgaria, 1431, Bulgaria

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Varna, Bulgaria, 9010, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Helsinki, Finland, 00029, Finland

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HUS, 00029, Finland

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Pori, FIN-28500, Finland

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Turku, 20521, Finland

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Nyíregyháza, Hungary, 4400, Hungary

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Budapest, 1046, Hungary

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Budapest, 1125, Hungary

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Győr, 9024, Hungary

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Makó, 6900, Hungary

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Pécs, 7635, Hungary

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Százhalombatta, 2440, Hungary

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Szolnok, H-5000, Hungary

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Törökbálint, 2045, Hungary

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Barceloneta, 00617, Puerto Rico

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San Juan, 00909, Puerto Rico

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San Juan, 00918, Puerto Rico

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Bucharest, District 1, 10457, Romania

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Bucharest, District 1, 11475, Romania

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Bucharest, District 3, 030303, Romania

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Bucharest, District 3, 030317, Romania

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Constanța, Jud. Constanta, 900002, Romania

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Iași, Jud. Iasi, 700115, Romania

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Brasov, Romania, 500281, Romania

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Novartis Investigative Site

Bucharest, 060011, Romania

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Bucharest, 50554, Romania

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Novartis Investigative Site

Cluj-Napoca, 400371, Romania

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Novartis Investigative Site

Granada, Andalusia, 18014, Spain

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Málaga, Andalusia, 29010, Spain

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Novartis Investigative Site

Badalona, Catalonia, 08914, Spain

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Barcelona, Catalonia, Spain

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Novartis Investigative Site

Canet de Mar, Catalonia, 08360, Spain

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Novartis Investigative Site

Centelles, Catalonia, 08540, Spain

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Novartis Investigative Site

Tarragona, Catalonia, 43350, Spain

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Novartis Investigative Site

Valencia, Valencia, 46015, Spain

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; indacaterol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 11, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 30, 2016
• Results First Posted: March 30, 2016

Record last verified: 2016-02

Locations

PR (3); BU (5); US (47); FI (4); HU (9); ES (8); RO (10)