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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00624702
First received: February 15, 2008
Last updated: August 26, 2010
Last verified: August 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 98
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
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
Placebo Comparator: 4 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:

  • 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.

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

Locations
Canada, Ontario
Novartis Investigator Site
Ottawa, Ontario, Canada
Canada, Quebec
Novartis Investigator Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00624702     History of Changes
Other Study ID Numbers: CQAB149B2102
Study First Received: February 15, 2008
Last Updated: August 26, 2010
Health Authority: Canada: Health Canada

Keywords provided by Novartis:
Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013