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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00624702

Enrollment

Registered

2008-02-27

Start date

2008-02-29

Completion date

2008-09-30

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)

Brief summary

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

Interventions

DRUGIndacaterol 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

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

Measure	Time frame
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
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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026