Clinical trial NCT01285492: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
QVA149
NVA237
indacaterol
combination bronchodilator
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death
timeFrame: 52 weeks
Secondary outcomes:
measure: Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
timeFrame: 52 weeks
measure: Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
timeFrame: 52 weeks
measure: Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
timeFrame: 52 weeks
measure: Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period
timeFrame: 52 weeks
measure: Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
timeFrame: Weeks 3, 6, 12, 24, 36, 52
measure: Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
timeFrame: Weeks 3, 6, 12, 24, 36, 52
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nishio-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kasuga-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Yanagawa
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Asahikawa
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Obihiro
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Himeji-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Takamatsu
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Kawasaki
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Koshi-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Matsusaka-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Ueda
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osakasayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Toyonaka
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kawaguhi-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hamamatsu
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Fuchu
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Meguro
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Yamagata city
country: Japan
facility: Novartis Investigative Site
state: Yamagata
city: Ube
country: Japan
facility: Novartis Investigative Site
state: Yamaguchi
city: Akita
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Kochi
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Wakayama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: