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A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01202188

Last Updated: 2013-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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QVA149, COPD, combination bronchodilator, indacaterol, glycopyrronium bromide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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indacaterol and glycopyrronium (QVA149)

QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Group Type EXPERIMENTAL

indacaterol and glycopyrronium (QVA149)

Intervention Type DRUG

Capsules for inhalation delivered via SDDPI.

glycopyrronium (NVA237)

NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Group Type ACTIVE_COMPARATOR

glycopyrronium (NVA237)

Intervention Type DRUG

Capsules for inhalation delivered via SDDPI.

indacaterol (QAB149)

QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Group Type ACTIVE_COMPARATOR

indacaterol (QAB149)

Intervention Type DRUG

Capsules for inhalation delivered via SDDPI.

tiotropium

Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Group Type ACTIVE_COMPARATOR

tiotropium

Intervention Type DRUG

Capsules for inhalation delivered via HandiHaler® device.

Placebo

Matching placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo to match capsules for inhalation delivered via SDDPI.

Interventions

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indacaterol and glycopyrronium (QVA149)

Capsules for inhalation delivered via SDDPI.

Intervention Type DRUG

glycopyrronium (NVA237)

Capsules for inhalation delivered via SDDPI.

Intervention Type DRUG

indacaterol (QAB149)

Capsules for inhalation delivered via SDDPI.

Intervention Type DRUG

tiotropium

Capsules for inhalation delivered via HandiHaler® device.

Intervention Type DRUG

placebo

Placebo to match capsules for inhalation delivered via SDDPI.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female adults aged ≥40 yrs
* Smoking history of at least 10 pack years
* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
* Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

Exclusion Criteria

* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for inhaled anticholinergic agents and β2 agonists
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_CHAIR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Fullerton, California, United States

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Riverside, California, United States

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St. Petersburg, Florida, United States

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Troy, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Charlotte, North Carolina, United States

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Columbus, Ohio, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Greenville, South Carolina, United States

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Johnson City, Tennessee, United States

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Daw Park, , Australia

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Glebe, , Australia

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Kogarah, , Australia

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Nedlands, , Australia

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New Lambton, , Australia

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Pleven, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Vancouver, British Columbia, Canada

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Burlington, Ontario, Canada

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Courtice, Ontario, Canada

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Mississuaga, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Beuvry, , France

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Bourges, , France

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Ferolles-Attily, , France

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Rennes, , France

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Berlin, , Germany

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Erfurt, , Germany

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Geesthacht, , Germany

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Hanover, , Germany

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Leipzig, , Germany

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Minden, , Germany

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Witten, , Germany

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Guatemala City, , Guatemala

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Balassagyarmat, , Hungary

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Budapest, , Hungary

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Győr, , Hungary

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Komárom, , Hungary

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Nyíregyháza, , Hungary

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Tatabánya, , Hungary

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Asahikawa, , Japan

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Chiba, , Japan

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Chūōku, , Japan

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Fukuoka, , Japan

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Hachiōji, , Japan

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Hamakita, , Japan

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Himeji, , Japan

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Hiroshima, , Japan

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Hitachi, , Japan

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Iwata, , Japan

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Kamogawa, , Japan

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Kishiwada, , Japan

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Kiyose, , Japan

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Kurashiki, , Japan

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Matsumoto, , Japan

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Matsusaka, , Japan

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Minatoku, , Japan

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Moriya, , Japan

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Nagaoka, , Japan

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Nagoya, , Japan

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Niigata, , Japan

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Obihiro, , Japan

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Sakai, , Japan

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Sakaidechō, , Japan

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Sapporo, , Japan

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tabashi City, , Japan

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Tachikawa, , Japan

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Takatsuki, , Japan

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Tsu, , Japan

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Yabu, , Japan

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Yanagawa, , Japan

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Yatsushiro, , Japan

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Yonezawa, , Japan

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Bulacan, , Philippines

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Las Piñas, , Philippines

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Manila, , Philippines

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Pasay, , Philippines

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Quezon City, , Philippines

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Krakow, , Poland

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Proszowice, , Poland

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Tarnów, , Poland

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Warsaw, , Poland

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Barnaul, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Nizhny Novogorod, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Ufa, , Russia

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Bardejov, , Slovakia

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Bojnice, , Slovakia

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Bratislava, , Slovakia

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Humenné, , Slovakia

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Košice, , Slovakia

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Liptovský Hrádok, , Slovakia

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Partizánske, , Slovakia

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Prievidza, , Slovakia

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Spišská Nová Ves, , Slovakia

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Trstená, , Slovakia

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Zvolen, , Slovakia

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Žilina, , Slovakia

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Cape Town, , South Africa

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Durban, , South Africa

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Johannesburg, , South Africa

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Lyttleton, , South Africa

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Pretoria, , South Africa

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Alzira, , Spain

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Badalona, , Spain

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Barcelona, , Spain

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Canet de Mar, , Spain

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Centelles, , Spain

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Ferrol, , Spain

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Fuenlabrada, , Spain

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les Borges del Camp, , Spain

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Madrid, , Spain

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Mataró, , Spain

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Mérida, , Spain

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Motril, , Spain

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Móstoles, , Spain

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Palma de Mallorca, , Spain

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Ponferrada, , Spain

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Salamanca, , Spain

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Salt, , Spain

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Valencia, , Spain

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Vic, , Spain

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Basel, , Switzerland

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Lugano, , Switzerland

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Münchenstein, , Switzerland

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Neuchâtel, , Switzerland

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Zurich, , Switzerland

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Chai-Yi, , Taiwan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Adana, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Bolu, , Turkey (Türkiye)

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Bursa, , Turkey (Türkiye)

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Çanakkale, , Turkey (Türkiye)

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Denizli, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Manisa, , Turkey (Türkiye)

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Mersin, , Turkey (Türkiye)

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Bath, , United Kingdom

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Blackpool, , United Kingdom

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Bradford, , United Kingdom

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Cambs, , United Kingdom

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Chelmsford, , United Kingdom

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Chesterfield, , United Kingdom

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Glasgow, , United Kingdom

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Herts, , United Kingdom

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Isle of Wight, , United Kingdom

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London, , United Kingdom

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Countries

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United States Australia Bulgaria Canada France Germany Guatemala Hungary Japan Philippines Poland Russia Slovakia South Africa Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

References

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Kulich K, Keininger DL, Tiplady B, Banerji D. Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study. Int J Chron Obstruct Pulmon Dis. 2015 Jan 7;10:79-94. doi: 10.2147/COPD.S73092. eCollection 2015.

Reference Type DERIVED
PMID: 25609942 (View on PubMed)

Other Identifiers

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2009-017772-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQVA149A2303

Identifier Type: -

Identifier Source: org_study_id