Clinical trial NCT00794157: Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in 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: 2008-11-19
Enrollment: 347
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 was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:

  1. Smoking history of at least 20 pack-years.
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value.
  3. Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%.

Exclusion Criteria:

* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization.
* Patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia.
* Patients who have had a respiratory tract infection within 6 weeks prior to screening.
* Patients with concomitant pulmonary disease.
* Patients with a history of asthma.
* Patients with diabetes Type I or uncontrolled diabetes Type II.
* Any patient with lung cancer or a history of lung cancer.
* Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time.
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged.
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
* Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
timeFrame: End of treatment (Week 12 + 1 day, Day 85)
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2
timeFrame: After Week 2 (Day 15)
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
timeFrame: After Week 4 (Day 29)
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8
timeFrame: After Week 8 (Day 57)
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)
timeFrame: Prior to last dose at Week 12 (Day 84)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Novartis Investigator Site
city: New Territories
country: Hong Kong
facility: Novartis Investigator Site
city: Ahmedabad
country: India
facility: Novartis Investigative Site
city: Bangalore
country: India
facility: Novartis Investigator Site
city: Coimbatore
country: India
facility: Novartis Investigative Site
city: Coimbatore
country: India
facility: Novartis Investigator Site
city: India
country: India
facility: Novartis Investigator Site
city: Mumbai
country: India
facility: Novartis Investigative Site
city: Panjim
country: India
facility: Novartis Investigative Center
city: Asahikawa
country: Japan
facility: Novartis Investigative Site
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
city: Gifu
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: Kawasaki
country: Japan
facility: Novartis Investigative 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 Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigator Site
city: Maebashi
country: Japan
facility: Novartis Investigative Site
city: Matsusaka-City
country: Japan
facility: Novartis Investigator Site
city: Morioka
country: Japan
facility: Novartis Investigative Site
city: Nagaoka-City
country: Japan
facility: Novartis Investigator Site
city: Nagoya
country: Japan
facility: Novartis Investigator Site
city: Noda
country: Japan
facility: Novartis Investigative Site
city: Obihiro
country: Japan
facility: Novartis Investigative Site
city: Sakai
country: Japan
facility: Novartis Investigator Site
city: Sapporo
country: Japan
facility: Novartis Investigative Site
city: Sendai
country: Japan
facility: Novartis Investigator Site
city: Seto
country: Japan
facility: Novartis Investigator Site
city: Tenri
country: Japan
facility: Novartis Investigator Site
city: Tokyo
country: Japan
facility: Novartis Investigative site
city: Toyonaka
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 Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigator Site
city: Jung-gu
country: Korea, Republic of
facility: Novartis Investigator Site
city: Kangwon-Do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Pusan
country: Korea, Republic of
facility: Novartis Investigator Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigator Site
city: Singapore
country: Singapore
facility: Novartis Investigator Site
city: Chia-Yi
country: Taiwan
facility: Novartis Investigator Site
city: Hsintien
country: Taiwan
facility: Novartis Investigator Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigator Site
city: Keelung
country: Taiwan
facility: Novartis Investigative Site
city: LinKou
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigator Site
city: Taipei County
country: Taiwan
facility: Novartis Investigator Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: To Y, Kinoshita M, Lee SH, Hang LW, Ichinose M, Fukuchi Y, Kitawaki T, Okino N, Prasad N, Lawrence D, Kramer B. Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population. Respir Med. 2012 Dec;106(12):1715-21. doi: 10.1016/j.rmed.2012.09.002. Epub 2012 Oct 5.