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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Indacaterol maleate

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Novartis Investigator Site
  • Quebec
    • Montreal, Quebec, Canada
      • Novartis Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 4	Drug: Placebo
Active Comparator: 1; Active Comparator 1 different salt formulation of Indacaterol.	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
Active Comparator: 2; Active Comparator 2 different salt formulation of Indacaterol.	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
Active Comparator: 3; Active Comparator 3 different salt formulation of Indacaterol.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Occurrence of cough within 1 minute post dose	throughout the study
Number of coughs	throughout the study
Duration of coughing	throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Occurrence of cough within 1 minute post dose	throughout the study
Number of coughs	throughout the study
Duration of coughing	throughout the study

Collaborators and Investigators

• Sponsor: Novartis

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: February 15, 2008
• First Submitted That Met QC Criteria: February 25, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Maleic acid
• Other Study ID Numbers: CQAB149B2102