Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD) (ARISE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01285492

First received: January 25, 2011

Last updated: November 2, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 25, 2011

Last Updated Date

November 2, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of QVA149 with regard to treatment-emergent adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

treatment-emergent adverse events

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01285492 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety of QVA149 as compared with tiotropium with regard to vital signs, electrocardiogram (ECG), and laboratory measurements [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
vital signs (blood pressure, pulse rate), ECG, laboratory measurements (hematology, urinalysis, clinical chemistry)
To assess the safety of QVA149 as compared with tiotropium with regard to study drug discontinuation [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Measure: study drug discontinuation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Official Title ^ICMJE

Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Brief Summary

This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 (glycopyrronium bromide) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

Drug: QVA149
Drug: Tiotropium

Study Arm (s)

Experimental: QVA149
QVA149 delivered once daily via a single-dose dry powder inhaler (SDDPI)

Intervention: Drug: QVA149
Active Comparator: Tiotropium
Tiotropium delivered once-daily via HandiHaler

Intervention: Drug: Tiotropium

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Completion Date

September 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
Patients with post-bronchodilator forced expiratory volume in one second (FEV1) ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) < 0.7 at Visit 2.

Exclusion Criteria:

Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
Patients requiring long term oxygen therapy
Patients who have had a lower respiratory tract infection within 4 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years
Patients with a history of certain cardiovascular comorbid 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 treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01285492

Other Study ID Numbers ^ICMJE

CQVA149A1301

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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