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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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Indacaterol acetate 75 μg
Indacaterol acetate 150 μg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring indacaterol acetate, asthma, GINA 2015, pediatrics

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Indacaterol acetate 75 μg o.d.

Indacaterol acetate 150 μg o.d.

Arm Description

Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler

Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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)
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.
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.
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.
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).
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)

Full Information

First Posted
September 1, 2016
Last Updated
January 15, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02892019
Brief 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
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
indacaterol acetate, asthma, GINA 2015, pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol acetate 75 μg o.d.
Arm Type
Active Comparator
Arm Description
Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
Arm Title
Indacaterol acetate 150 μg o.d.
Arm Type
Active Comparator
Arm Description
Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
Intervention Type
Drug
Intervention Name(s)
Indacaterol acetate 75 μg
Other Intervention Name(s)
QAB149
Intervention Description
Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
Intervention Type
Drug
Intervention Name(s)
Indacaterol acetate 150 μg
Other Intervention Name(s)
QAB149
Intervention Description
Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
Primary Outcome Measure Information:
Title
Trough Forced Expiratoty Volume in 1 Second (FEV1)
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Systemic Exposure to Indacaterol in Plasma
Description
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.
Time Frame
day 1, day 14
Title
Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire
Description
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
Time Frame
2 weeks
Title
Pre-dose Morning and Evening Peak Expiratoty Flow (PEF)
Description
Pre-dose morning and evening PEF over 2 weeks of treatment as determined by electronic peak flow meter data (mean change)
Time Frame
2 weeks
Title
Rescue Medication Usage (Mean Daiily Number of Puffs)
Description
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.
Time Frame
2 weeks
Title
Rescue Medication Usage (Percentage of Rescue Medication Free Days)
Description
Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.
Time Frame
2 weeks
Title
Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)
Description
FEV1 and FVC at 30 minutes and 1-hour post dose at week 2 for indacaterol acetate 75 μg and 150 μg o.d.
Time Frame
2 weeks
Title
Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score)
Description
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).
Time Frame
2 weeks
Title
Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days)
Description
Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bogota
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bucaramanga
Country
Colombia
Facility Name
Novartis Investigative Site
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Facility Name
Novartis Investigative Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Novartis Investigative Site
City
Hamm
ZIP/Postal Code
D 59063
Country
Germany
Facility Name
Novartis Investigative Site
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Novartis Investigative Site
City
Rosenheim
ZIP/Postal Code
83026
Country
Germany
Facility Name
Novartis Investigative Site
City
Guatemala City
State/Province
GTM
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guatemala City
ZIP/Postal Code
01011
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Torokbalint
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szigetvar
ZIP/Postal Code
7900
Country
Hungary
Facility Name
Novartis Investigative Site
City
Manila
State/Province
Metro Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Novartis Investigative Site
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Novartis Investigative Site
City
Quezon City
ZIP/Postal Code
1113
Country
Philippines
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St.Petersburg
ZIP/Postal Code
196240
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nitra
State/Province
Slovak Republic
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Nove Zamky
State/Province
SVK
ZIP/Postal Code
94001
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Middelburg
State/Province
Mpumalanga
ZIP/Postal Code
1050
Country
South Africa
Facility Name
Novartis Investigative Site
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7531
Country
South Africa
Facility Name
Novartis Investigative Site
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Novartis Investigative Site
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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