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

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2016-002113-21-SK
• Date of registration: 12/01/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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
• Scientific 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 - Efficacy and safety of indacaterol acetate delivered via the Concept1 in children
• Date of first enrolment: 18/04/2017
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002113-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: DRA information desk
• Affiliation: Novartis Slovakia s.r.o.

• Name: DRA information desk
• Affiliation: Novartis Slovakia s.r.o.

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

lung function effects of two doses of indacaterol acetate, 75 µg and 150 µg, in pediatric asthma patients 6-11 years old
MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Name: Indacaterol acetate
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol acetate
Other descriptive name: INDACATEROL ACETATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-

Product Name: Indacaterol acetate
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol acetate
Other descriptive name: INDACATEROL ACETATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 75-

Primary Outcome(s)

Secondary Objective: Systemic exposure to indacaterol in plasma

Primary end point(s): Primary Outcome Measure:
• Trough FEV1 [Time Frame: 2 weeks] [Designated as safety issue: No]
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.

Main Objective: 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

Timepoint(s) of evaluation of this end point: Time Frame: 2 weeks

Secondary Outcome(s)

Secondary end point(s): Secondary Outcome Measures:
• Systemic exposure to indacaterol in plasma [Time Frame: 2 weeks]
[Designated as safety issue: No]
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.
• Asthma Control as assessed by pediatric interviewer-administered Asthma
Control Questionnaire [Time Frame: 2 weeks] [Designated as safety
issue: No]
Asthma Control as assessed by pediatric interviewer-administered
Asthma Control Questionnaire (ACQ-IA) score at week 2 for
indacaterol acetate 75 µg and 150 µg o.d.
• FEV1 and FVC [Time Frame: 2 weeks] [Designated as safety issue: No]
FEV1 and FVC at 30 minutes and 1-hour post dose at week 2 for
indacaterol acetate 75 µg and 150 µg o.d.
• Rescue medication usage [Time Frame: 2 weeks] [Designated as safety
issue: No]
Rescue medication usage over 2 weeks of treatment as determined
by patient diary data for indacaterol acetate 75 µg and 150 µg o.d.
• Symptoms as recorded by patient e-diary [Time Frame: 2 weeks]
[Designated as safety issue: No]
Symptoms as recorded by patient e-diary for indacaterol acetate 75
µg and 150 µg o.d.
• Pre-dose morning and evening PEF [Time Frame: 2 weeks] [Designated
as safety issue: No]
Pre-dose morning and evening PEF over 2 weeks of treatment as
determined by electronic peak flow meter data.

Timepoint(s) of evaluation of this end point: Time Frame: 2 weeks

Secondary ID(s)

CQMF149G2202

2016-002113-21-DE

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact: