Dose Ranging Study for Indacaterol in Japanese Asthma Patients

NCT00403754 | Completed Phase 2 Results

• 1 other identifier: CQAB149A1202
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 8

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

Keywords

asthma; QAB149; indacaterol; long acting β2-agonist; bronchodilator

Outcome Measures

Primary Outcomes (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

  Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.

  22, 23, and 24 hours post-dose on Day 2

Secondary Outcomes (3)

• 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

  5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2

• Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1

  5 minutes to 4 hours post-dose on Day 1

• Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2

  5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2

Study Arms (4)

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

EXPERIMENTAL

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.

Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol

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

EXPERIMENTAL

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.

Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol

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

EXPERIMENTAL

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.

Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol

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

EXPERIMENTAL

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.

Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol

Interventions

Indacaterol DRUG

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

Also known as: QAB149

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

Placebo DRUG

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

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

Salmeterol 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.

Also known as: Serevent

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Kasukabe, Japan

Location

Novartis Investigator Site

Kishiwada, Japan

Location

Novartis Investigative Site

Shimotsuga, Japan

Location

Novartis Investigator Site

Suita, Japan

Location

Novartis Investigative Site

Tokyo, Japan

Location

Novartis

Tokyo, Japan

Location

Novartis Investigator Site

Wakayama, Japan

Location

Novartis Investigator Site

Yokohama, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

indacaterol; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals Japan

  Novartis Pharmaceuticals Japan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 23, 2006
• First Posted: November 27, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 17, 2011
• Results First Posted: August 17, 2011

Record last verified: 2011-07

Locations

JP (8)