Clinical trial NCT02892019: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: indacaterol acetate, asthma, GINA 2015, pediatrics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 79
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

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.

Primary outcomes:
measure: Trough Forced Expiratoty Volume in 1 Second (FEV1)
timeFrame: 2 weeks
Secondary outcomes:
measure: Systemic Exposure to Indacaterol in Plasma
timeFrame: day 1, day 14
measure: Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire
timeFrame: 2 weeks
measure: Pre-dose Morning and Evening Peak Expiratoty Flow (PEF)
timeFrame: 2 weeks
measure: Rescue Medication Usage (Mean Daiily Number of Puffs)
timeFrame: 2 weeks
measure: Rescue Medication Usage (Percentage of Rescue Medication Free Days)
timeFrame: 2 weeks
measure: Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)
timeFrame: 2 weeks
measure: Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score)
timeFrame: 2 weeks
measure: Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Bucaramanga
country: Colombia
facility: Novartis Investigative Site
city: Slavonski Brod
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Hamm
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Rosenheim
country: Germany
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
state: GTM
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
state: Pest
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Szigetvar
country: Hungary
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
state: SVK
city: Middelburg
country: South Africa
facility: Novartis Investigative Site
state: Mpumalanga
city: Panorama
country: South Africa
facility: Novartis Investigative Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: