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

February 15, 2008
August 26, 2010
February 2008
September 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00624702 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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
  • Drug: Placebo
  • Active Comparator: 1
    Active Comparator 1 different salt formulation of Indacaterol.
    Intervention: Drug: Indacaterol maleate
  • Active Comparator: 2
    Active Comparator 2 different salt formulation of Indacaterol.
    Intervention: Drug: Indacaterol maleate
  • Active Comparator: 3
    Active Comparator 3 different salt formulation of Indacaterol.
    Intervention: Drug: Indacaterol maleate
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
September 2008
September 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00624702
CQAB149B2102
No
Novartis
Novartis
Not Provided
Principal Investigator: Novartis Novartis investigator site
Novartis
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP