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

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: December 3, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: QVA149
Drug: Tiotropium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Weeks 3, 6, 12, 24, 36, 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 3, 6, 12, 24, 36, 52 ] [ Designated as safety issue: No ]
    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).


Enrollment: 160
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QVA149
QVA149 110/50 μg once a day (o.d)
Drug: QVA149
QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1
Active Comparator: Tiotropium
tiotropium 18 μg o.d.
Drug: Tiotropium
Tiotropium (18 μg o.d.), delivered via Handihaler®

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285492

Locations
Japan
Novartis Investigative Site
Anjo, Aichi, Japan, 446-8602
Novartis Investigative Site
Nagoya, Aichi, Japan, 457-8511
Novartis Investigative Site
Nishio-city, Aichi, Japan, 445-8510
Novartis Investigative Site
Kasuga-city, Fukuoka, Japan, 816-0813
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 820-0052
Novartis Investigative Site
Kurume, Fukuoka, Japan, 830-0011
Novartis Investigative Site
Yanagawa, Fukuoka, Japan, 832-0059
Novartis Investigative Site
Asahikawa, Hokkaido, Japan, 070-8644
Novartis Investigative Site
Obihiro, Hokkaido, Japan, 080-0805
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site
Himeji-city, Hyogo, Japan, 672-8064
Novartis Investigative Site
Kanazawa, Ishikawa, Japan, 920-8610
Novartis Investigative Site
Takamatsu, Kagawa, Japan, 760-8538
Novartis Investigative Site
Kawasaki, Kanagawa, Japan, 210-0852
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 236-0051
Novartis Investigative Site
Koshi-city, Kumamoto, Japan, 861-1196
Novartis Investigative Site
Matsusaka-city, Mie, Japan, 515-8544
Novartis Investigative Site
Ueda, Nagano, Japan, 386-8610
Novartis Investigative Site
Osaka-city, Osaka, Japan, 545-8586
Novartis Investigative Site
Osakasayama, Osaka, Japan, 589-0022
Novartis Investigative Site
Takatsuki, Osaka, Japan, 569-1192
Novartis Investigative Site
Toyonaka, Osaka, Japan, 560-8552
Novartis Investigative Site
Kawaguhi-city, Saitama, Japan, 333-0833
Novartis Investigative Site
Hamamatsu, Shizuoka, Japan, 430-8525
Novartis Investigative Site
Fuchu, Tokyo, Japan, 183-8524
Novartis Investigative Site
Meguro, Tokyo, Japan, 152-8902
Novartis Investigative Site
Yamagata city, Yamagata, Japan, 990-8533
Novartis Investigative Site
Ube, Yamaguchi, Japan, 755-0241
Novartis Investigative Site
Akita, Japan, 010-0933
Novartis Investigative Site
Fukuoka, Japan, 815-8588
Novartis Investigative Site
Fukuoka, Japan, 811-0213
Novartis Investigative Site
Fukuoka, Japan, 812-0033
Novartis Investigative Site
Kochi, Japan, 780-8077
Novartis Investigative Site
Osaka, Japan, 558-8558
Novartis Investigative Site
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01285492     History of Changes
Other Study ID Numbers: CQVA149A1301
Study First Received: January 25, 2011
Results First Received: September 4, 2013
Last Updated: December 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
COPD
QVA149
NVA237
indacaterol
combination bronchodilator

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014