Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Indacaterol acetate 75 μg; Drug: Indacaterol acetate 150 μg

• Registration Number: NCT02892019
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Study Start: 2017-04-18
• Primary Completion: 2019-06-19
• Study Completion: 2019-07-17
• Status Verified: 2020-01
• Results First Submitted: 2020-01-15
• Results First Submitted QC: 2020-01-15
• Last Update Submitted: 2020-01-15
• Results First Posted: 2020-01-27
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• Male and female children ≥ 6 years and < 12 years with confirmed diagnosis of asthma for at least 1 year prior to study enrollment.
• Written informed consent by parent(s)/legal guardian(s) and depending upon their age and local requirements a consent or assent for the patient.
• Patients receiving daily treatment with a stable low dose Inhaled Corticosteroid (ICS) (with or without additional controller), or patients receiving daily treatment with a stable mid-dose ICS (monotherapy or together with LTRA) for at least 4 weeks prior to Screening, and able to tolerate fluticasone propionate 100 μg b.i.d. inhaler starting at Visit 1 (or soon after).
• Patients with a pre-bronchodilator FEV1 ≥ 50% and ≤ 90% of the predicted normal value for the patient at the start and end of Run-in (Visits 101 and 199).
• Patients who demonstrate an increase in FEV1 of 12% within 30 minutes after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Visit 101. All patients must perform a reversibility test at Visit 101.

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Exclusion Criteria

• Patients taking a mid-dose ICS (per GINA guidelines) in combination with LABA or any patient taking high-dose ICS.
• Evidence of unstable disease within 4 weeks prior to Screening (Visit 1).
• Patients who have had an asthma attack/exacerbation requiring systemic steroids (SCS) or hospitalization or emergency room visit within 3 months prior to Visit 1 (Screening) or more than 3 separate exacerbations in the 12 months preceding Visit 1.
• Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Screening (Visit 1).
• Prior intubation for asthma.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indacaterol acetate 75 μg o.d.	Indacaterol acetate 75 μg	Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
Indacaterol acetate 150 μg o.d.	Indacaterol acetate 150 μg	Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler

Primary Outcome Measures

Name	Time	Method
Trough Forced Expiratoty Volume in 1 Second (FEV1)	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Pre-dose Morning and Evening Peak Expiratoty Flow (PEF)	2 weeks	Pre-dose morning and evening PEF over 2 weeks of treatment as determined by electronic peak flow meter data (mean change)
Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days)	2 weeks	Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change)
Rescue Medication Usage (Mean Daiily Number of Puffs)	2 weeks	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.
Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)	2 weeks	FEV1 and FVC at 30 minutes and 1-hour post dose at week 2 for indacaterol acetate 75 μg and 150 μg o.d.
Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score)	2 weeks	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).
Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire	2 weeks	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
Rescue Medication Usage (Percentage of Rescue Medication Free Days)	2 weeks	Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.
Systemic Exposure to Indacaterol in Plasma	day 1, day 14	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇷 Ankara, Turkey