Clinical trial NCT00792805: Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase III, 26-week 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
indacaterol
long-acting β2-agonist
adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 563
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 evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.


Eligibility criteria: Inclusion Criteria:

* Adults aged ≥ 40 years
* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

  1. Smoking history of at least 10 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 received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
* 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 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) at Week 12 + 1 Day, Day 85
timeFrame: Week 12 + 1 day, Day 85
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Novartis Investigative Site
city: Clayton
country: Australia
facility: Novartis Investigative Site
city: Daw Park
country: Australia
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Changsha
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Fuzhou
country: China
facility: Novartis Investigator Site
city: Guang Zhou
country: China
facility: Novartis Investigative Site
city: Shandong
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shenyang
country: China
facility: Novartis Investigative Site
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
city: Xi'an
country: China
facility: Novartis Investigative Site
city: Bangalore
country: India
facility: Novartis Investigative Site
city: Trivandrum
country: India
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Yao W, Wang C, Zhong N, Han X, Wu C, Yan X, Chen P, Yang W, Henley M, Kramer B. Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: a 26-week Asia-Pacific study. Respirology. 2014 Feb;19(2):231-238. doi: 10.1111/resp.12211. Epub 2014 Jan 3.