Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma

Novartis98 enrolled

Overview

This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

Indacaterol maleateDRUG

Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval

Indacaterol maleateDRUG

Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval

Indacaterol maleateDRUG

Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients 18 to 65 years old (inclusive) * Patients with mild to moderate persistent asthma * BMI must be within the range of 18-32 kg/m2 inclusive * Female subjects must: 1. have been sterilized at least 6 months prior to screening 2. be post-menopausal with no regular bleeding for at least a year prior to inclusion Exclusion Criteria: * Patients with life-threatening arrhythmias * Patients with COPD or diabetes mellitus * History of immunocompromise, including a positive HIV * A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result Other protocol-defined inclusion/exclusion criteria may apply.

Locations (2)

Novartis Investigator Site

Ottawa, Ontario, Canada

Novartis Investigator Site

Montreal, Quebec, Canada