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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892019
• Other study ID #: CQMF149G2202
• Secondary ID: 2016-002113-21
• Status: Completed
• Phase: Phase 2
• Start date: April 18, 2017
• Est. completion date: July 17, 2019

Study information

• Verified date: January 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 17, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Indacaterol acetate 75 µg
Indacaterol acetate 75 µg o.d. delivered via Concept1 inhaler
• Indacaterol acetate 150 µg
Indacaterol acetate 150 µg o.d. delivered via Concept1 inhaler

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Brussel
Colombia	Novartis Investigative Site	Bogota
Colombia	Novartis Investigative Site	Bucaramanga
Croatia	Novartis Investigative Site	Slavonski Brod
Croatia	Novartis Investigative Site	Zagreb
Germany	Novartis Investigative Site	Hamm
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Rosenheim
Guatemala	Novartis Investigative Site	Guatemala City	GTM
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szigetvar
Hungary	Novartis Investigative Site	Torokbalint	Pest
Philippines	Novartis Investigative Site	Manila	Metro Manila
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Quezon City
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	St.Petersburg
Slovakia	Novartis Investigative Site	Nitra	Slovak Republic
Slovakia	Novartis Investigative Site	Nove Zamky	SVK
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Middelburg	Mpumalanga
South Africa	Novartis Investigative Site	Panorama	Western Cape
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Colombia,  Croatia,  Germany,  Guatemala,  Hungary,  Philippines,  Russian Federation,  Slovakia,  South Africa,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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.	day 1, day 14
Secondary	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	2 weeks
Secondary	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)	2 weeks
Secondary	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.	2 weeks
Secondary	Rescue Medication Usage (Percentage of Rescue Medication Free Days)	Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 µg and 150 µg o.d.	2 weeks
Secondary	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.	2 weeks
Secondary	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).	2 weeks
Secondary	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)	2 weeks