NCT00624702

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

A Multi-center, Randomized, Single-dose, Double-blind, 4-way Cross-over Study to Evaluate Tolerability Following Treatment With Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

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

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Indacaterol maleate	Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
DRUG	Indacaterol maleate	Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
DRUG	Indacaterol maleate	Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
DRUG	Placebo

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-02-27
• Last updated: 2020-12-19

Locations

2 sites across 1 country: Canada