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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00624702

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Indacaterol maleate Drug: Placebo	Phase I

MedlinePlus related topics: Asthma Cough Dietary Sodium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	February 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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
3: Active Comparator 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
4: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

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:

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624702

Locations

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Novartis investigator site

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CQAB149B2102
Study First Received:	February 15, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00624702
Health Authority:	Canada: Health Canada

Keywords provided by Novartis:

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

Study placed in the following topic categories:

Asthma
Cough
Naphazoline
Oxymetazoline
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases

Maleic acid
Phenylephrine
Guaifenesin
Lung Diseases
Hypersensitivity, Immediate
Phenylpropanolamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Bronchial Diseases
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009