Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Indacaterol 150 μg capsules; Drug: Indacaterol 300 μg capsules; Drug: Placebo capsules

• Study Type: Interventional
• Enrollment (Actual): 347
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Novartis Investigator Site
  • New Territories, Hong Kong
    • Novartis Investigator Site
• India
  • Ahmedabad, India
    • Novartis Investigative Site
  • Bangalore, India
    • Novartis Investigator Site
  • Coimbatore, India
    • Novartis Investigator Site
  • Coimbatore, India
    • Novartis Investigative Site
  • India, India
    • Novartis Investigator Site
  • Mumbai, India
    • Novartis Investigative Site
  • Panjim, India
    • Novartis Investigative Center
• Japan
  • Asahikawa, Japan
    • Novartis Investigative Site
  • Bunkyo-ku, Japan
    • Novartis Investigative Site
  • Gifu, Japan
    • Novartis Investigator Site
  • Himeji, Japan
    • Novartis Investigator Site
  • Hiroshima, Japan
    • Novartis Investigator Site
  • Iwata, Japan
    • Novartis Investigator Site
  • Kanazawa, Japan
    • Novartis Investigator Site
  • Kawasaki, Japan
    • Novartis Investigative Site
  • Kishiwada, Japan
    • Novartis Investigator Site
  • Kitakyushu, Japan
    • Novartis Investigator Site
  • Kochi, Japan
    • Novartis Investigator Site
  • Koga, Japan
    • Novartis Investigator Site
  • Kurume, Japan
    • Novartis Investigative Site
  • Kyoto, Japan
    • Novartis Investigator Site
  • Maebashi, Japan
    • Novartis Investigative Site
  • Matsusaka-City, Japan
    • Novartis Investigator Site
  • Morioka, Japan
    • Novartis Investigative Site
  • Nagaoka-City, Japan
    • Novartis Investigator Site
  • Nagoya, Japan
    • Novartis Investigator Site
  • Noda, Japan
    • Novartis Investigative Site
  • Obihiro, Japan
    • Novartis Investigative Site
  • Sakai, Japan
    • Novartis Investigator Site
  • Sapporo, Japan
    • Novartis Investigative Site
  • Sendai, Japan
    • Novartis Investigator Site
  • Seto, Japan
    • Novartis Investigator Site
  • Tenri, Japan
    • Novartis Investigator Site
  • Tokyo, Japan
    • Novartis Investigative Site
  • Toyonaka, Japan
    • Novartis Investigator Site
  • Ube, Japan
    • Novartis Investigator Site
  • Wakayama, Japan
    • Novartis Investigator Site
  • Yabu, Japan
    • Novartis Investigator Site
  • Yanagawa, Japan
    • Novartis Investigator Site
  • Yokkaichi, Japan
    • Novartis Investigator Site
  • Yokohama, Japan
    • Novartis Investigative Site
• Korea, Republic of
  • Daegu, Korea, Republic of
    • Novartis Investigator Site
  • Jung-gu, Korea, Republic of
    • Novartis Investigator Site
  • Kangwon-Do, Korea, Republic of
    • Novartis Investigative Site
  • Pusan, Korea, Republic of
    • Novartis Investigator Site
  • Seoul, Korea, Republic of
    • Novartis Investigative Site
  • Seoul, Korea, Republic of
    • Novartis Investigator Site
• Singapore
  • Singapore, Singapore
    • Novartis Investigator Site
• Taiwan
  • Chia-Yi, Taiwan
    • Novartis Investigator Site
  • Hsintien, Taiwan
    • Novartis Investigator Site
  • Kaohsiung, Taiwan
    • Novartis Investigator Site
  • Keelung, Taiwan
    • Novartis Investigative Site
  • LinKou, Taiwan
    • Novartis Investigative Site
  • Taichung, Taiwan
    • Novartis Investigative Site
  • Taichung, Taiwan
    • Novartis Investigator Site
  • Taipei, Taiwan
    • Novartis Investigative Site
  • Taipei, Taiwan
    • Novartis Investigator Site
  • Taipei County, Taiwan
    • Novartis Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indacaterol 150 µg; Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol 150 μg capsules; Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Experimental: Indacaterol 300 µg; Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol 300 μg capsules; Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Placebo Comparator: Placebo; Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Placebo capsules; Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	End of treatment (Week 12 + 1 day, Day 85)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	After Week 2 (Day 15)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	After Week 4 (Day 29)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	After Week 8 (Day 57)
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.	Prior to last dose at Week 12 (Day 84)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: November 17, 2008
• First Submitted That Met QC Criteria: November 18, 2008
• First Posted (Estimate): November 19, 2008

Study Record Updates

• Last Update Posted (Estimate): August 17, 2011
• Last Update Submitted That Met QC Criteria: July 22, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: COPD; indacaterol; chronic obstructive pulmonary disease; long acting β2-agonist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CQAB149B1302