Clinical trial NCT00403754: Dose Ranging Study for Indacaterol in Japanese Asthma Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
QAB149
indacaterol
long acting β2-agonist
bronchodilator
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

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

Primary outcomes:
measure: 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
timeFrame: 22, 23, and 24 hours post-dose on Day 2
Secondary outcomes:
measure: 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
timeFrame: 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
measure: Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1
timeFrame: 5 minutes to 4 hours post-dose on Day 1
measure: 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
timeFrame: 5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2
Other outcomes:
Locations:
city: Kasukabe
country: Japan
facility: Novartis Investigative Site
city: Kishiwada
country: Japan
facility: Novartis Investigator Site
city: Shimotsuga
country: Japan
facility: Novartis Investigative Site
city: Suita
country: Japan
facility: Novartis Investigator Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis
city: Wakayama
country: Japan
facility: Novartis Investigator Site
city: Yokohama
country: Japan
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals Japan
name: Novartis Pharmaceuticals Japan
role: PRINCIPAL_INVESTIGATOR
References: