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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Indacaterol maleate; Drug: Placebo

• Registration Number: NCT00624702
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-02-27
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2010-08
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Indacaterol maleate	Active Comparator 1 different salt formulation of Indacaterol.
4	Placebo	-
2	Indacaterol maleate	Active Comparator 2 different salt formulation of Indacaterol.
3	Indacaterol maleate	Active Comparator 3 different salt formulation of Indacaterol.

Primary Outcome Measures

Name	Time	Method
Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)	throughout the study
Severity of cough: to be judged independently by both the patient and the physician	throughout the study
Duration of coughing	throughout the study
Occurrence of cough within 1 minute post dose	throughout the study
Number of coughs	throughout the study

Secondary Outcome Measures

Name	Time	Method
Severity of cough: to be judged independently by both the patient and the physician	throughout the study
Number of coughs	throughout the study
Occurrence of cough within 1 minute post dose	throughout the study
Duration of coughing	throughout the study
Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)	throughout the study

Trial Locations

Locations (1)

Novartis Investigator Site; 🇨🇦 Montreal, Quebec, Canada