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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

NCT ID: NCT01610037

Last Updated: 2016-06-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QVA149

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

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

Tiotropium

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type 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

Interventions

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QVA149

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

Intervention Type DRUG

Tiotropium

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

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Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Florida, Buenos Aires, Argentina

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Lanús, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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San Isidro, Buenos Aires, Argentina

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San Juan Bautista, Buenos Aires, Argentina

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Vicente López, Buenos Aires, Argentina

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Corrientes, Corrientes Province, Argentina

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Concepción del Uruguay, Entre Ríos Province, Argentina

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Mendoza, Mendoza Province, Argentina

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Mendoza, Mendoza Province, Argentina

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Santa Fe, Rosario, Argentina

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Salta, Salta Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Bogota, Cundinamarca, Colombia

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Armenia, , Colombia

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Sisak, Croatia, Croatia

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Zagreb, Croatia, Croatia

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Osijek, , Croatia

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Zagreb, , Croatia

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Tartu, Estonia, Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Cegléd, Hungary, Hungary

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Debrecen, Hungary, Hungary

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Érd, Hungary, Hungary

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Monor, Hungary, Hungary

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Siófok, Hungary, Hungary

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Szarvas, Hungary, Hungary

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Budapest, HUN, Hungary

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Csorna, , Hungary

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Eger, , Hungary

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Gödöllő, , Hungary

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Mosonmagyaróvár, , Hungary

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Hyderabad, A.p., India

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Hyderabad, Andhra Pradesh, India

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Panjim, Goa, India

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Ahmedabad, India, India

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Nagpur - Maharashtra, India, India

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Bangalore, Karnataka, India

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Mysore, Karnataka, India

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Trivandrum, Kerala, India

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Nagpur, Maharashtra, India

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Bikaner, Rajasthan, India

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Jaipur, Rajasthan, India

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Jaipur, Rajasthan, India

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Coimbatore, Tamil Nadu, India

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Vellore, Tamil Nadu, India

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Jerusalem, , Israel

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Rehovot, , Israel

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Daugavpils, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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León, Guanajuato, Mexico

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Pachuca, Hidalgo, Mexico

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Panama City, Provincia de Panamá, Panama

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Panama City, Provincia de Panamá, Panama

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Bialystok, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Moscow, , Russia

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Moscow, , Russia

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N.Novgorod, , Russia

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Nizhny Novgorod, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Yaroslavl, , Russia

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Knez-Selo, , Serbia

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Kragujevac, , Serbia

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Golnik, , Slovenia

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Bucheon-si, Gyeonggi-do, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Seoul, Seoul, South Korea

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Daegu, , South Korea

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Incheon, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Pendik / Istanbul, Turkey, Turkey (Türkiye)

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Kartal, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Yenisehir/Izmir, , Turkey (Türkiye)

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Royal Leamington Spa, Warwickshire, United Kingdom

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Bradford, West Yorkshire, United Kingdom

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Birmingham, , United Kingdom

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Birmingham, , United Kingdom

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Cheshire, , United Kingdom

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Doncaster, , United Kingdom

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Leeds, , United Kingdom

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Merseyside, , United Kingdom

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Newport, , United Kingdom

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Portsmouth, , United Kingdom

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Wolverhampton, , United Kingdom

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Countries

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Argentina Colombia Croatia Estonia Hungary India Israel Latvia Mexico Panama Poland Russia Serbia Slovenia South Korea Turkey (Türkiye) United Kingdom

Other Identifiers

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2012-002057-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQVA149A2339

Identifier Type: -

Identifier Source: org_study_id

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