A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Tolerability of QVA149 (110 Mcg Indacaterol / 50 Mcg Glycopyrrolate o.d.) Using Tiotropium (18 Mcg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Novartis Pharmaceuticals1 site in 1 country160 target enrollmentJanuary 2011

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsQVA149 Tiotropium

DrugsQVA149 Tiotropium

Overview

Phase: Phase 3
Intervention: QVA149
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Novartis Pharmaceuticals
Enrollment: 160
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

September 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Arms & Interventions

QVA149

QVA149 110/50 μg once a day (o.d)

Intervention: QVA149

Tiotropium

tiotropium 18 μg o.d.

Intervention: Tiotropium

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death

Time Frame: 52 weeks

An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.

Secondary Outcomes

Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period(52 weeks)
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period(52 weeks)
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline(Weeks 3, 6, 12, 24, 36, 52)
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period(52 weeks)
Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period(52 weeks)
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline(Weeks 3, 6, 12, 24, 36, 52)