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Dose Ranging Study for Indacaterol in Japanese Asthma Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00403754
First received: November 23, 2006
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Indacaterol
Drug: Placebo
Drug: Salmeterol
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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: 22, 23, and 24 hours post-dose on Day 2 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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: 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 ] [ Designated as safety issue: No ]
    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.

  • Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1 [ Time Frame: 5 minutes to 4 hours post-dose on Day 1 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: 5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2 ] [ Designated as safety issue: No ]
    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.


Enrollment: 41
Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Indacaterol
In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).
Other Name: QAB149
Drug: Placebo
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
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.
Other Name: Serevent
Experimental: 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.

Drug: Indacaterol
In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).
Other Name: QAB149
Drug: Placebo
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
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.
Other Name: Serevent
Experimental: 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.

Drug: Indacaterol
In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).
Other Name: QAB149
Drug: Placebo
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
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.
Other Name: Serevent
Experimental: 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.

Drug: Indacaterol
In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).
Other Name: QAB149
Drug: Placebo
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
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.
Other Name: Serevent

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403754

Locations
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, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals Japan
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00403754     History of Changes
Other Study ID Numbers: CQAB149A1202
Study First Received: November 23, 2006
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
asthma
QAB149
indacaterol
long acting β2-agonist
bronchodilator

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014