Clinical trial NCT01119937: Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients
Official title: A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Tolerability of NVA237 (50µg o.d.) Using Tiotropium (18µg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
NVA237
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 211
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, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, 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 Gold Guideline 2008.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients with a post-bronchodilator FEV1 ≥30% and \< 80% of the predicted normal, and postbronchodilator FEV1/FVC \< 0.7 at Visit 2 (day -7)

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 6 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* 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 tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Adverse Events, Serious Adverse Events or Death
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in Pre-dose FEV1 From Baseline
timeFrame: Weeks 12, 24, 36 and 52
measure: Change in Pre-dose FVC From Baseline
timeFrame: Weeks 12, 24, 36 and 52
measure: Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation
timeFrame: 52 weeks
measure: Number of Patients With Moderate or Severe COPD Exacerbations
timeFrame: 52 weeks
measure: Change in St. George Respiratory Questionnaire From Baseline
timeFrame: Weeks 12, 24, 36, 52
measure: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period
timeFrame: 52 weeks
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 Timepoint Over the Whole Treatment Period
timeFrame: 52 weeks
measure: Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
timeFrame: 52 weeks
measure: Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Iizuka
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu
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: Onojo
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
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Himeji-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Takarazuka
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Yabu
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Inashiki-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Naka-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Sashima-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Morioka
country: Japan
facility: Novartis Investigative Site
state: Iwate
city: Kawasaki
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Uji
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Matsusaka-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Sendai
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Nagaoka-City
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Nagaoka
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Kasaoka
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Tsuyama
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Osakasayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sakai
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Shimotsuka-gun
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ohta-ku
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: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Kochi
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Saitama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: