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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
QVA149
Tiotropium
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, QVA149, NVA237, indacaterol, combination bronchodilator

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QVA149

Tiotropium

Arm Description

QVA149 110/50 μg once a day (o.d)

tiotropium 18 μg o.d.

Outcomes

Primary Outcome Measures

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

Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.
Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period
Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).

Full Information

First Posted
January 25, 2011
Last Updated
December 3, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01285492
Brief Title
Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, QVA149, NVA237, indacaterol, combination bronchodilator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QVA149
Arm Type
Experimental
Arm Description
QVA149 110/50 μg once a day (o.d)
Arm Title
Tiotropium
Arm Type
Active Comparator
Arm Description
tiotropium 18 μg o.d.
Intervention Type
Drug
Intervention Name(s)
QVA149
Intervention Description
QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
Tiotropium (18 μg o.d.), delivered via Handihaler®
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Description
Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL
Time Frame
52 weeks
Title
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
Description
Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL
Time Frame
52 weeks
Title
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Description
Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.
Time Frame
52 weeks
Title
Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period
Description
Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).
Time Frame
52 weeks
Title
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Description
Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).
Time Frame
Weeks 3, 6, 12, 24, 36, 52
Title
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Description
Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).
Time Frame
Weeks 3, 6, 12, 24, 36, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Anjo
State/Province
Aichi
ZIP/Postal Code
446-8602
Country
Japan
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Novartis Investigative Site
City
Nishio-city
State/Province
Aichi
ZIP/Postal Code
445-8510
Country
Japan
Facility Name
Novartis Investigative Site
City
Kasuga-city
State/Province
Fukuoka
ZIP/Postal Code
816-0813
Country
Japan
Facility Name
Novartis Investigative Site
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
820-0052
Country
Japan
Facility Name
Novartis Investigative Site
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Novartis Investigative Site
City
Yanagawa
State/Province
Fukuoka
ZIP/Postal Code
832-0059
Country
Japan
Facility Name
Novartis Investigative Site
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Novartis Investigative Site
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0805
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Novartis Investigative Site
City
Himeji-city
State/Province
Hyogo
ZIP/Postal Code
672-8064
Country
Japan
Facility Name
Novartis Investigative Site
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8610
Country
Japan
Facility Name
Novartis Investigative Site
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-8538
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Novartis Investigative Site
City
Koshi-city
State/Province
Kumamoto
ZIP/Postal Code
861-1196
Country
Japan
Facility Name
Novartis Investigative Site
City
Matsusaka-city
State/Province
Mie
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Novartis Investigative Site
City
Ueda
State/Province
Nagano
ZIP/Postal Code
386-8610
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Novartis Investigative Site
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-0022
Country
Japan
Facility Name
Novartis Investigative Site
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1192
Country
Japan
Facility Name
Novartis Investigative Site
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawaguhi-city
State/Province
Saitama
ZIP/Postal Code
333-0833
Country
Japan
Facility Name
Novartis Investigative Site
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8525
Country
Japan
Facility Name
Novartis Investigative Site
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-8524
Country
Japan
Facility Name
Novartis Investigative Site
City
Meguro
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Novartis Investigative Site
City
Yamagata city
State/Province
Yamagata
ZIP/Postal Code
990-8533
Country
Japan
Facility Name
Novartis Investigative Site
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
Novartis Investigative Site
City
Akita
ZIP/Postal Code
010-0933
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
811-0213
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
812-0033
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
815-8588
Country
Japan
Facility Name
Novartis Investigative Site
City
Kochi
ZIP/Postal Code
780-8077
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Novartis Investigative Site
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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