Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

• ClinicalTrials.gov Identifier: NCT00403845
• Recruitment Status: Completed
• First Posted: November 27, 2006
• Results First Posted: August 17, 2011
• Last Update Posted: August 17, 2011
• Sponsor: Novartis
• Information provided by: Novartis

Study Description

Brief Summary:

The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Indacaterol 150 μg; Drug: Indacaterol 300 μg; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, and 600 µg) Delivered Via a Single Dose Dry Powder Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
• Study Start Date: December 2006
• Actual Primary Completion Date: October 2007
• Actual Study Completion Date: October 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg; In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Drug: Indacaterol 150 μg; Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Drug: Indacaterol 300 μg; Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Drug: Placebo; Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Experimental: Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg; In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Drug: Indacaterol 150 μg; Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Drug: Indacaterol 300 μg; Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Drug: Placebo; Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Experimental: Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg; In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Drug: Indacaterol 150 μg; Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Drug: Indacaterol 300 μg; Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Drug: Placebo; Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Experimental: Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo; In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Drug: Indacaterol 150 μg; Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Drug: Indacaterol 300 μg; Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Drug: Placebo; Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Outcome Measures

Primary Outcome Measures :

1. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2 [ Time Frame: From 22 to 24 hours post-dose on Day 2 ]
   FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate.

Secondary Outcome Measures :

1. Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 [ Time Frame: From 5 minutes to 4 hours post-dose on Day 1 ]
   FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.
2. Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2 [ Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 ]
   FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.
3. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2 [ Time Frame: From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2 ]
   FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male and female Japanese aged 40 to 75 years old
• Moderate to severe chronic obstructive pulmonary disease (COPD) with smoking history of at least 20 pack years

Exclusion Criteria:

• History of hospitalization for COPD exacerbation within past 6 months
• Use of long-term oxygen therapy
• History of asthma
• Respiratory tract infection within past 1 month
• Consistently very high or low blood sugar
• Clinically abnormal laboratory values or significant condition
• History of heart failure or heart attack within past 6 months
• History of long QT syndrome or long QT interval in electrocardiogram recorded at screening

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

Contacts and Locations

Locations

Japan

Novartis Investigative site

Kasukabe, Japan

Novartis Investigator Site

Kishiwada, Japan

Novartis Investigative Site

Kurume, Japan

Novartis Investigative Site

Obihiro, Japan

Novartis Investigative Site

Sagamihara, Japan

Novartis Investigative Site

Sapporo, Japan

Novartis Investigator Site

Tokyo, Japan

Novartis Investigative Site

Wakayama, Japan

Sponsors and Collaborators

Novartis

Investigators

• Principal Investigator: Novartis Pharmaceuticals Japan; Novartis

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hosoe M, Woessner R, Matsushima S, Lawrence D, Kramer B. Efficacy, safety and pharmacokinetics of indacaterol in Caucasian and Japanese patients with chronic obstructive pulmonary disease: a comparison of data from two randomized, placebo-controlled studies. Clin Drug Investig. 2011;31(4):247-55. doi: 10.2165/11586520-000000000-00000.

• Responsible Party: External Affairs, Novartis
• ClinicalTrials.gov Identifier: NCT00403845
• Other Study ID Numbers: CQAB149B1202
• First Posted: November 27, 2006
• Results First Posted: August 17, 2011
• Last Update Posted: August 17, 2011
• Last Verified: July 2011

Keywords provided by Novartis:

chronic obstructive pulmonary disease; COPD; QAB149; indacaterol; long acting β2-agonist

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases