i

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

PHRR170908-001688

CQMF149G2202

2017-CT0415

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

This study uses a randomized, multicenter, double-blind, active-controlled study design.  The primary endpoint will be evaluated after 2 weeks of treatment with indacaterol acetate as change from baseline in children ³6years and

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-08-22 13 2018-09-22 2019-08-30

Completed

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR CDRR-NCR-S-1
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR
Institution Region
Novartis Healthcare Philippines, Inc. NCR
Name E-Mail Institution and Institution Address
Anna Liza Calingasin anna_liza.calingasin@novartis.com 2nd floor ARCC Bldg Salcedo cor Gamboa Sts Legaspi Village Makati City 1229
Name E-Mail Institution and Institution Address
Lawrence Allen Tria lawrence_allen.tria@novartis.com 2nd floor ARCC Bldg Salcedo cor Gamboa Sts Legaspi Village Makati City 1229
Name Expertise Affiliation
Marysia Stella P. Tiongco-Recto, MD Allergologist Pediatrician University of the Philippines - Philippine General Hospital, Department of Pediatrics
Milagros S. Bautista, MD Pediatrics Pulmonology University of the East Ramon Magsaysay Memorial Medical Center
Rommel Crisenio Lobo, MD Pulmonology Hospital Of The Infant Jesus
Project Location Institutional Ethics Review Board
University of the Philippines - Philippine General Hospital, Department of Pediatrics N/A
University of the East Ramon Magsaysay Memorial Medical Center N/A
Hospital Of The Infant Jesus N/A

asthma

To evaluate indacaterol acetate 75 µg o.d and 150 µg o.d. in terms of change from baseline in pre-dose trough FEV1 after 2 weeks of treatment.

·         To evaluate the systemic exposure to indacaterol in plasma following sparse pharmacokinetic (PK) sampling on Day 1 and Day 14 after oral inhalation of indacaterol acetate 75 µg and 150 µg

·         To evaluate the clinical effects and pharmacodynamics of indacaterol acetate (75 μg and 150 μg o.d.) after 2 weeks of treatment in terms of:

·         Pediatric interviewer-administered Asthma Control Questionnaire (ACQ-IA) score at Week 2

·         FEV1 and forced vital capacity (FVC) rate at 30 minutes and 1-hour post dose at Week 2

·         Rescue medication usage over 2 weeks of treatment as determined by patient diary data

·         Symptoms as recorded by patient e-diary

·         Pre-dose morning and evening peak expiratory flow (PEF) over 2 weeks of treatment as determined by electronic peak flow meter data.

To evaluate the safety (including labs, vital signs, ECG, adverse events), and tolerability of indacaterol acetate (75 and 150 μg o.d.) over 2 weeks of treatment. 

Completed

  • Belgium
  • Colombia
  • Croatia
  • Germany
  • Guatemala
  • Hungary
  • Philippines
  • Russia
  • Slovakia
  • South Africa

Clinical Trial

CQMF149G2202

20170601125754

2017-08-22

0000-00-00

15

4

Only 4 patients were randomized in the trial.

2017-08-22

1.      Male and female children ≥ 6 years and < 12 years with confirmed diagnosis of asthma for at least 1 year prior to study enrollment.

2.      Written informed consent by parent(s)/legal guardian(s) and depending upon their age and local requirements a consent or assent for the patient.

3.      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).

4.      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).

·  Withholding period of bronchodilators prior to spirometry at Visit 101: SABA for ≥ 6 hours and FDC or free combinations of ICS/ Long Acting Beta-2 Agonist (LABA) for ≥ 48 hours, o.d. LABA for at ≥ 14 days,  SAMA for ≥ 8 hours, LAMA for ≥ 7 days, xanthines ≥ 7 days

·  One-time re-testing of pre-bronchodilator FEV1 is allowed only at Visit 101. Re-assessment should be done in an ad-hoc visit before randomization.

5.      Patients who demonstrate an increase in FEV1 of ³ 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. Use of spacer devices is mandatory. Reversibility may be repeated once.

A single parent/legal guardian must be designated to complete all e-Diary entries and attend all clinic visits with the patient.
 
Exclusion

1.      Patients taking a mid-dose ICS (per GINA guidelines) in combination with LABA or any patient taking high-dose ICS.

2.      Evidence of unstable disease within 4 weeks prior to Screening (Visit 1).

3.      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. If patients experience an asthma attack/exacerbation requiring SCS or hospitalization between Visit 1 and Visit 199 they may be re-screened 3 months after recovery from the exacerbation.

4.      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).

5.      Prior intubation for asthma

Patients who, in the opinion of the investigator, are not able to be compliant with study treatments, properly use study drug devices (e.g. DPI, MDI, Concept1, peak flow meter), or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements

Interventional

Indacaterol acetate

The Investigational treatments are as follows:

·         Indacaterol acetate 75 µg capsules for inhalation, delivered via Concept1

·         Indacaterol acetate 150 µg capsules for inhalation, delivered via Concept1

Indacaterol acetate will be provided as powder filled capsules with a Concept1 inhalation device. 

None

Randomized

Double Blind

At Visit 201, all eligible patients will be randomized via Interactive Response Technology (IRT) to one of the treatment arms above. The investigator or his/her delegate will contact the IRT after confirming that the patient fulfills all the inclusion/exclusion criteria. The IRT will assign a randomization number to the patient, which will be used to link the patient to a treatment arm and will specify a unique medication number for the first package of study drug to be dispensed to the patient. The randomization number will not be communicated to the caller. The randomization numbers will be generated using the following procedure to ensure that treatment assignment is unbiased and concealed from patients/subjects and investigator staff. A patient randomization list will be produced by the IRT provider using a validated system that automates the random assignment of patient numbers to randomization numbers. These randomization numbers are linked to the different treatment arms, which in turn are linked to medication numbers. A separate medication list will be produced by or under the responsibility of Novartis Drug Supply Management using a validated system that automates the random assignment of medication numbers to packs containing the investigational drug(s). Randomization will be stratified by region. The randomization scheme for patients will be reviewed and approved by a member of the COAR Randomization Group.

Parallel

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.

Phase II

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
©2021 HERDIN PLUS. All rights reserved. | Contact Us | Keep up to date