Dose Ranging Study for Indacaterol in Japanese Asthma Patients

NCT ID: NCT00403754

Last Updated: 2011-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-11-30

Brief Summary

This study was designed to provide data about the safety and efficacy of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or doses, could be chosen for testing in later studies.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol

In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).

Placebo

Intervention Type: DRUG

Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Salmeterol

Intervention Type: DRUG

Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol

In treatment period 1: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).

Placebo

Intervention Type: DRUG

Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Salmeterol

Intervention Type: DRUG

Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol

In treatment period 1: patients received 1 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).

Placebo

Intervention Type: DRUG

Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Salmeterol

Intervention Type: DRUG

Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Ind 600 μg-Ind 300 μg-Ind 150 μg-Placebo-Salmeterol

In treatment period 1: patients received 2 indacaterol (Ind) 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. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).

Placebo

Intervention Type: DRUG

Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Salmeterol

Intervention Type: DRUG

Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Interventions

Indacaterol

In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).

Intervention Type: DRUG

Placebo

Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Intervention Type: DRUG

Salmeterol

Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.

Intervention Type: DRUG

Other Intervention Names

QAB149; Serevent

Eligibility Criteria

Inclusion Criteria

• Male and female Japanese asthmatic patients aged 18 to 75 years old.

Exclusion Criteria

• Patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to the first day of screening or during the screening period.
• Patients who have used tobacco products within 6 months prior to the first day of screening or have a smoking history of greater than 10 pack years.
• Patients with a history of malignancy with the exception of localized basal cell carcinoma of the skin.
• Pregnant or nursing (lactating) women.
• Patients who have had treatment with disallowed medications including investigational drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharmaceuticals Japan

Role: PRINCIPAL_INVESTIGATOR

Novartis Pharmaceuticals Japan

Locations

Novartis Investigative Site

Kasukabe, , Japan

Novartis Investigator Site

Kishiwada, , Japan

Novartis Investigative Site

Shimotsuga, , Japan

Novartis Investigator Site

Suita, , Japan

Novartis Investigative Site

Tokyo, , Japan

Novartis

Tokyo, , Japan

Novartis Investigator Site

Wakayama, , Japan

Novartis Investigator Site

Yokohama, , Japan

Countries

Japan

Other Identifiers

CQAB149A1202

Identifier Type: -

Identifier Source: org_study_id