Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation

NCT01610037 | Completed Phase 3 Results DMC

• 2 other identifiers: CQVA149A23392012-002057-38
• Study Type: interventional
• Target: 1,215
• Locations: 17 countries
• Sites: 116

Brief Summary

The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease; COPD; QVA149; QAB149; NVA237; Indacaterol maleate; Glycopyronnium bromide

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Serious Adverse Events

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

  Week 52

Secondary Outcomes (11)

• Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.

  52 weeks

• Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE

  52 weeks

• Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)

  Day 22, 43, 85, 183, 274 and 364

• Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)

  Measurment at day 364

• Change From Baseline in Daily, Morning and Evening Symptom Scores

  52 weeks

Study Arms (3)

QVA149

EXPERIMENTAL

Drug: QVA149

Tiotropium

ACTIVE COMPARATOR

Drug: Tiotropium

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

QVA149 DRUG

QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI

QVA149

Tiotropium DRUG

Tiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI

Tiotropium

placebo DRUG

placebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI

placebo

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 (116)

Novartis Investigative Site

Buenos Aires, Buenos Aires, 1425, Argentina

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Novartis Investigative Site

Buenos Aires, Buenos Aires, B1842DID, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, 1028, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1113AAC, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1122AAK, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1180AAX, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1425AUA, Argentina

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Novartis Investigative Site

Florida, Buenos Aires, B1602DQD, Argentina

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Novartis Investigative Site

Lanús, Buenos Aires, B8000XAV, Argentina

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Novartis Investigative Site

Mar del Plata, Buenos Aires, B7600FZN, Argentina

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Novartis Investigative Site

Quilmes, Buenos Aires, B1878FNR, Argentina

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Novartis Investigative Site

San Isidro, Buenos Aires, B1642DCD, Argentina

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Novartis Investigative Site

San Juan Bautista, Buenos Aires, B2705XAE, Argentina

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Novartis Investigative Site

Vicente López, Buenos Aires, B1638AAI, Argentina

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Novartis Investigative Site

Corrientes, Corrientes Province, W3400, Argentina

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Novartis Investigative Site

Concepción del Uruguay, Entre Ríos Province, E3260EPD, Argentina

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Novartis Investigative Site

Mendoza, Mendoza Province, 5500, Argentina

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Novartis Investigative Site

Mendoza, Mendoza Province, M5500CBA, Argentina

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Novartis Investigative Site

Santa Fe, Rosario, S2000DBS, Argentina

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Novartis Investigative Site

Salta, Salta Province, 4000, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, S2000AII, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, S2000CXH, Argentina

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Novartis Investigative Site

Santa Fe, Santa Fe Province, S3000FIL, Argentina

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Novartis Investigative Site

Santa Fe, Santa Fe Province, S3000FWO, Argentina

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Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Novartis Investigative Site

Bogota, Cundinamarca, Colombia

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Novartis Investigative Site

Armenia, Colombia

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Novartis Investigative Site

Barranquilla, Colombia

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Novartis Investigative Site

Bogotá, Colombia

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Novartis Investigative Site

Sisak, Croatia, 44000, Croatia

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Novartis Investigative Site

Zagreb, Croatia, 10 000, Croatia

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Novartis Investigative Site

Osijek, 31000, Croatia

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Novartis Investigative Site

Zagreb, 10000, Croatia

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Novartis Investigative Site

Tartu, Estonia, 51014, Estonia

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Novartis Investigative Site

Tallinn, 13419, Estonia

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Novartis Investigative Site

Tallinn, 13619, Estonia

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Novartis Investigative Site

Cegléd, Hungary, 2700, Hungary

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Novartis Investigative Site

Debrecen, Hungary, 4032, Hungary

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Novartis Investigative Site

Érd, Hungary, H-2030, Hungary

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Novartis Investigative Site

Monor, Hungary, 2200, Hungary

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Novartis Investigative Site

Siófok, Hungary, 8600, Hungary

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Novartis Investigative Site

Szarvas, Hungary, 5540, Hungary

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Novartis Investigative Site

Budapest, HUN, 1204, Hungary

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Novartis Investigative Site

Csorna, H-9300, Hungary

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Novartis Investigative Site

Eger, 3300, Hungary

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Novartis Investigative Site

Gödöllő, 2100, Hungary

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Novartis Investigative Site

Mosonmagyaróvár, 9200, Hungary

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Novartis Investigative Site

Hyderabad, A.p., 500 001, India

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Novartis Investigative Site

Hyderabad, Andhra Pradesh, 500004, India

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Novartis Investigative Site

Panjim, Goa, 403 002, India

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Novartis Investigative Site

Ahmedabad, India, 380009, India

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Novartis Investigative Site

Nagpur - Maharashtra, India, 440012, India

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Novartis Investigative Site

Bangalore, Karnataka, 560002, India

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Novartis Investigative Site

Mysore, Karnataka, 570004, India

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Novartis Investigative Site

Trivandrum, Kerala, 695 011, India

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Novartis Investigative Site

Nagpur, Maharashtra, 440033, India

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Novartis Investigative Site

Bikaner, Rajasthan, 334 001, India

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Novartis Investigative Site

Jaipur, Rajasthan, 302 039, India

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Novartis Investigative Site

Jaipur, Rajasthan, 302023, India

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Novartis Investigative Site

Coimbatore, Tamil Nadu, 641 045., India

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Novartis Investigative Site

Vellore, Tamil Nadu, 632004, India

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Novartis Investigative Site

Jerusalem, 91031, Israel

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Novartis Investigative Site

Jerusalem, 9112001, Israel

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Novartis Investigative Site

Petah Tikva, 49100, Israel

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Novartis Investigative Site

Rehovot, 76100, Israel

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Novartis Investigative Site

Daugavpils, LV-5401, Latvia

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Novartis Investigative Site

Riga, 1002, Latvia

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Novartis Investigative Site

Riga, LV-1038, Latvia

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Novartis Investigative Site

León, Guanajuato, 37000, Mexico

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Novartis Investigative Site

Pachuca, Hidalgo, 42090, Mexico

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Novartis Investigative Site

Mexico City, Mexico City, 06726, Mexico

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Novartis Investigative Site

Mexico City, Mexico City, 14050, Mexico

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Novartis Investigative Site

Panama City, Provincia de Panamá, 0834-00363, Panama

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Novartis Investigative Site

Panama City, Provincia de Panamá, Panama

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Novartis Investigative Site

Bialystok, 15-044, Poland

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Novartis Investigative Site

Katowice, 40-752, Poland

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Novartis Investigative Site

Krakow, 31-159, Poland

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Novartis Investigative Site

Lodz, 90-153, Poland

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Novartis Investigative Site

Lodz, 90-302, Poland

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Novartis Investigative Site

Moscow, 115280, Russia

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Novartis Investigative Site

Moscow, 125315, Russia

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Novartis Investigative Site

N.Novgorod, 603126, Russia

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Novartis Investigative Site

Nizhny Novgorod, 603018, Russia

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Novartis Investigative Site

Ryazan, 390026, Russia

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Novartis Investigative Site

Saint Petersburg, 193231, Russia

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Novartis Investigative Site

Saint Petersburg, 193312, Russia

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Novartis Investigative Site

Saint Petersburg, 194354, Russia

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Novartis Investigative Site

Saratov, 410012, Russia

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Novartis Investigative Site

Yaroslavl, 150003, Russia

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Novartis Investigative Site

Knez-Selo, 18204, Serbia

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Novartis Investigative Site

Kragujevac, 34000, Serbia

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Novartis Investigative Site

Golnik, 4204, Slovenia

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Novartis Investigative Site

Bucheon-si, Gyeonggi-do, 14584, South Korea

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Novartis Investigative Site

Seoul, Korea, 03080, South Korea

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Novartis Investigative Site

Seoul, Korea, 130-709, South Korea

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Novartis Investigative Site

Seoul, Seoul, 156-755, South Korea

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Novartis Investigative Site

Daegu, 705-703, South Korea

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Novartis Investigative Site

Incheon, 403-720, South Korea

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Novartis Investigative Site

Incheon, 405-760, South Korea

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Novartis Investigative Site

Seoul, 130-872, South Korea

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Novartis Investigative Site

Pendik / Istanbul, Turkey, 1330, Turkey (Türkiye)

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Novartis Investigative Site

Kartal, 34890, Turkey (Türkiye)

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Novartis Investigative Site

Kocaeli, 41380, Turkey (Türkiye)

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Novartis Investigative Site

Mersin, 33079, Turkey (Türkiye)

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Novartis Investigative Site

Yenisehir/Izmir, 35110, Turkey (Türkiye)

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Novartis Investigative Site

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

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Novartis Investigative Site

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Novartis Investigative Site

Birmingham, B15 2WB, United Kingdom

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Novartis Investigative Site

Birmingham, B9 5SS, United Kingdom

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Novartis Investigative Site

Cheshire, CW1 4QJ, United Kingdom

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Novartis Investigative Site

Doncaster, DN2 5LT, United Kingdom

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Novartis Investigative Site

Leeds, LS9 7TF, United Kingdom

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Novartis Investigative Site

Merseyside, CH49 5PE, United Kingdom

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Novartis Investigative Site

Newport, P030 5TG, United Kingdom

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Novartis Investigative Site

Portsmouth, PO6 3AD, United Kingdom

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Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; Tiotropium Bromide

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)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 15, 2016
• Results First Posted: June 15, 2016

Record last verified: 2016-05

Locations

IN (14); SE (2); ME (4); PL (5); CO (4); PA (2); ES (3); IL (4); GB (11); AR (25); RU (10); KR (8); LA (3); CR (4); SL (1); HU (11); TU (5)