This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
Trough Forced Expiratoty Volume in 1 Second (FEV1)
Change from baseline in pre-dose trough FEV1 after 2 weeks of treatment with indacaterol acetate 75 μg o.d and 150 μg o.d. The primary endpoint is change from baseline in pre-dose trough FEV1 (mL) after 2 weeks of treatment. The pre-dose trough FEV1 (mL) is defined as the mean of the two FEV1 (mL), values measured at -45 min and -15 min pre-dose.
Time frame: 2 weeks
Systemic Exposure to Indacaterol in Plasma
Systemic exposure to indacaterol in plasma following sparse pharmacokinetic (PK) sampling on Day 1 and Day 14 after inhalation of indacaterol acetate 75 μg and 150 μg.
Time frame: day 1, day 14
Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire
Asthma Control as assessed by pediatric interviewer-administered Asthma Control Questionnaire (ACQ-IA) score at week 2 (mean change). A decrease in the score shows an improvement. The scale ranges from 0 (no symptoms) to 6 (severe symptoms every day). Results are given as a change as compared from baseline
Time frame: 2 weeks
Pre-dose Morning and Evening Peak Expiratoty Flow (PEF)
Pre-dose morning and evening PEF over 2 weeks of treatment as determined by electronic peak flow meter data (mean change)
Time frame: 2 weeks
Rescue Medication Usage (Mean Daiily Number of Puffs)
Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.Results given as mean change of puffs of rescue medication.
Time frame: 2 weeks
Rescue Medication Usage (Percentage of Rescue Medication Free Days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Bruges, Belgium
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Bogotá, Colombia
Novartis Investigative Site
Bucaramanga, Colombia
Novartis Investigative Site
Slavonski Brod, Croatia
Novartis Investigative Site
Zagreb, Croatia
Novartis Investigative Site
Hamm, Germany
Novartis Investigative Site
Mannheim, Germany
Novartis Investigative Site
Rosenheim, Germany
Novartis Investigative Site
Guatemala City, GTM, Guatemala
...and 19 more locations
Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.
Time frame: 2 weeks
Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)
FEV1 and FVC at 30 minutes and 1-hour post dose at week 2 for indacaterol acetate 75 μg and 150 μg o.d.
Time frame: 2 weeks
Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score)
Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change) The scale rages from 0 (no problem) - 4 (very severe problems).
Time frame: 2 weeks
Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days)
Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change)
Time frame: 2 weeks