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

NCT01285492 | Completed Phase 3 Results

• 1 other identifier: CQVA149A1301
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 35

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; QVA149; NVA237; indacaterol; combination bronchodilator

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Secondary Outcomes (6)

• Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period

  52 weeks

• 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 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

Study Arms (2)

QVA149

EXPERIMENTAL

QVA149 110/50 μg once a day (o.d)

Drug: QVA149

Tiotropium

ACTIVE COMPARATOR

tiotropium 18 μg o.d.

Drug: Tiotropium

Interventions

QVA149 DRUG

QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1

QVA149

Tiotropium DRUG

Tiotropium (18 μg o.d.), delivered via Handihaler®

Tiotropium

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (35)

Novartis Investigative Site

Anjo, Aichi-ken, 446-8602, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 457-8511, Japan

Location

Novartis Investigative Site

Nishio, Aichi-ken, 445-8510, Japan

Location

Novartis Investigative Site

Akita, Akita, 010-0933, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 811-0213, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-0033, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 815-8588, Japan

Location

Novartis Investigative Site

Kasuga, Fukuoka, 816-0813, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 820-0052, Japan

Location

Novartis Investigative Site

Kurume, Fukuoka, 830-0011, Japan

Location

Novartis Investigative Site

Yanagawa, Fukuoka, 832-0059, Japan

Location

Novartis Investigative Site

Asahikawa, Hokkaido, 070-8644, Japan

Location

Novartis Investigative Site

Obihiro, Hokkaido, 080-0805, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Novartis Investigative Site

Himeji, Hyōgo, 672-8064, Japan

Location

Novartis Investigative Site

Kanazawa, Ishikawa-ken, 920-8610, Japan

Location

Novartis Investigative Site

Takamatsu, Kagawa-ken, 760-8538, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 210-0852, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 236-0051, Japan

Location

Novartis Investigative Site

Kochi, Kochi, 780-8077, Japan

Location

Novartis Investigative Site

Kōshi, Kumamoto, 861-1196, Japan

Location

Novartis Investigative Site

Matsusaka, Mie-ken, 515-8544, Japan

Location

Novartis Investigative Site

Ueda, Nagano, 386-8610, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 545-8586, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 558-8558, Japan

Location

Novartis Investigative Site

Sayama, Osaka, 589-0022, Japan

Location

Novartis Investigative Site

Takatsuki, Osaka, 569-1192, Japan

Location

Novartis Investigative Site

Toyonaka, Osaka, 560-8552, Japan

Location

Novartis Investigative Site

Kawaguhi-city, Saitama, 333-0833, Japan

Location

Novartis Investigative Site

Hamamatsu, Shizuoka, 430-8525, Japan

Location

Novartis Investigative Site

Fuchū, Tokyo, 183-8524, Japan

Location

Novartis Investigative Site

Meguro City, Tokyo, 152-8902, Japan

Location

Novartis Investigative Site

Wakayama, Wakayama, 641-8510, Japan

Location

Novartis Investigative Site

Yamagata, Yamagata, 990-8533, Japan

Location

Novartis Investigative Site

Ube, Yamaguchi, 755-0241, Japan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 28, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 27, 2013
• Results First Posted: November 7, 2013

Record last verified: 2013-12

Locations

JP (35)