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COMPLETEDPHASE2

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

A Multicenter, Randomized, Double-blind, Active-controlled, 2 Week Treatment, Parallel-group Study to Assess the 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

NCT02892019•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 11 years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (29)

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

Key Dates

Start Date

April 18, 2017

Primary Completion Date

June 19, 2019

Completion Date

July 17, 2019

Last Updated

January 27, 2020

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

Indacaterol acetate 75 μg

DRUG

Indacaterol acetate 150 μg

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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