Clinical trial NCT00876694: Confirmatory Study of Indacaterol in 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 Efficacy of Indacaterol (300 µg o.d.) Using Salmeterol (50 µg b.i.d.) as an Active Control in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 186
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 study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:

* Smoking history of at least 20 pack-years
* Post-bronchodilator FEV1 \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

Exclusion Criteria:

1. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
3. Patients with concomitant pulmonary disease
4. Patients with a history of asthma
5. Patients with diabetes Type I or uncontrolled diabetes Type II
6. Any patient with lung cancer or a history of lung cancer
7. Patients with a history of certain cardiovascular comorbid conditions
8. Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment
timeFrame: 52 weeks
measure: The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment
timeFrame: 52 weeks
measure: The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment
timeFrame: 52 weeks
measure: The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment
timeFrame: 52 weeks
measure: Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52
timeFrame: 4, 8, 12, 24, 36, 44, and 52 weeks
measure: Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52
timeFrame: 4, 8, 12, 24, 36, 44, and 52 weeks
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks
timeFrame: After 12, 24 and 52 weeks
Other outcomes:
Locations:
city: Asahikawa
country: Japan
facility: Novartis Investigator Site
city: Bunkyo-ku
country: Japan
facility: Novartis Investigator Site
city: Gifu
country: Japan
facility: Novartis Investigator Site
city: Hamamatsu
country: Japan
facility: Novartis Investigator Site
city: Himeji
country: Japan
facility: Novartis Investigator Site
city: Hiroshima
country: Japan
facility: Novartis Investigator Site
city: Iwata
country: Japan
facility: Novartis Investigator Site
city: Kanazawa
country: Japan
facility: Novartis Investigator Site
city: Kasaoka
country: Japan
facility: Novartis Investigator Site
city: Kawasaki
country: Japan
facility: Novartis Investigator Site
city: Kishiwada
country: Japan
facility: Novartis Investigator Site
city: Kitakyushu
country: Japan
facility: Novartis Investigator Site
city: Kochi
country: Japan
facility: Novartis Investigator Site
city: Koga
country: Japan
facility: Novartis Investigator Site
city: Kurume
country: Japan
facility: Novartis Investigator Site
city: Kyoto
country: Japan
facility: Novartis Investigator Site
city: Maebashi
country: Japan
facility: Novartis Investigator Site
city: Matsusaka-city
country: Japan
facility: Novartis Investigator Site
city: Morioka
country: Japan
facility: Novartis Investigator Site
city: Nagaoka-city
country: Japan
facility: Novartis Investigator Site
city: Nagoya
country: Japan
facility: Novartis Investigator Site
city: Naka-gun
country: Japan
facility: Novartis Investigator Site
city: Noda
country: Japan
facility: Novartis Investigator Site
city: Obihiro
country: Japan
facility: Novartis Investigator Site
city: Sakai
country: Japan
facility: Novartis Investigator Site
city: Sapporo
country: Japan
facility: Novartis Investigator site
city: Sendai
country: Japan
facility: Novartis Investigator Site
city: Setagaya-ku
country: Japan
facility: Novartis Investigator Site
city: Sumida-ku
country: Japan
facility: Novartis Investigator Site
city: Tenri
country: Japan
facility: Novartis Investigator Site
city: Tokyo
country: Japan
facility: Novartis Investigator Site
city: Ube
country: Japan
facility: Novartis Investigator Site
city: Wakayama
country: Japan
facility: Novartis Investigator Site
city: Yabu
country: Japan
facility: Novartis Investigator Site
city: Yanagawa
country: Japan
facility: Novartis Investigator Site
city: Yokkaichi
country: Japan
facility: Novartis Investigator Site
city: Yokohama
country: Japan
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: