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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624702
• Other study ID #: CQAB149B2102
• Status: Completed
• Phase: Phase 1
• Start date: February 2008
• Est. completion date: September 2008

Study information

• Verified date: August 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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
• 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
• 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
• Placebo

Locations

Country	Name	City	State
Canada	Novartis Investigator Site	Montreal	Quebec
Canada	Novartis Investigator Site	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)		throughout the study
Primary	Severity of cough: to be judged independently by both the patient and the physician		throughout the study
Primary	Occurrence of cough within 1 minute post dose		throughout the study
Primary	Number of coughs		throughout the study
Primary	Duration of coughing		throughout the study
Secondary	Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)		throughout the study
Secondary	Severity of cough: to be judged independently by both the patient and the physician		throughout the study
Secondary	Occurrence of cough within 1 minute post dose		throughout the study
Secondary	Number of coughs		throughout the study
Secondary	Duration of coughing		throughout the study

External Links

•   Results for QAB149B2102 can be found on the Novartis Clinical Trial Results Website