Dose Ranging Study for Indacaterol in Japanese Asthma Patients

Asthma Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Single-dose, Dose-ranging Study Followed by a Single Day's Treatment With Open Label Salmeterol Bid (100 µg/Day), to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, & 600 µg) Delivered Via Single Dose Dry Powder Inhaler (SDDPI) in Japanese Asthma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403754
• Other study ID #: CQAB149A1202
• Status: Completed
• Phase: Phase 2
• First received: November 23, 2006
• Last updated: July 22, 2011
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Indacaterol
In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).
• Placebo
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
• 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.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Kasukabe
Japan	Novartis Investigator Site	Kishiwada
Japan	Novartis Investigative Site	Shimotsuga
Japan	Novartis Investigator Site	Suita
Japan	Novartis	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigator Site	Wakayama
Japan	Novartis Investigator Site	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.	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	No
Secondary	Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1	Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. 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.	5 minutes to 4 hours post-dose on Day 1	No
Secondary	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	Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 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.	5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2	No