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

• ClinicalTrials.gov Identifier: NCT02892019
• Recruitment Status: Completed
• First Posted: September 8, 2016
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Indacaterol acetate 75 μg; Drug: Indacaterol acetate 150 μg	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 18, 2017
• Actual Primary Completion Date: June 19, 2019
• Actual Study Completion Date: July 17, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Indacaterol acetate 75 μg o.d.; Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler	Drug: Indacaterol acetate 75 μg; Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler; Other Name: QAB149
Active Comparator: Indacaterol acetate 150 μg o.d.; Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler	Drug: Indacaterol acetate 150 μg; Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler; Other Name: QAB149

Outcome Measures

Primary Outcome Measures :

1. Trough Forced Expiratoty Volume in 1 Second (FEV1) [ Time Frame: 2 weeks ]

   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 :

1. Systemic Exposure to Indacaterol in Plasma [ Time Frame: day 1, day 14 ]
   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.
2. Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire [ Time Frame: 2 weeks ]

   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

3. Pre-dose Morning and Evening Peak Expiratoty Flow (PEF) [ Time Frame: 2 weeks ]
   Pre-dose morning and evening PEF over 2 weeks of treatment as determined by electronic peak flow meter data (mean change)
4. Rescue Medication Usage (Mean Daiily Number of Puffs) [ Time Frame: 2 weeks ]
   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.
5. Rescue Medication Usage (Percentage of Rescue Medication Free Days) [ Time Frame: 2 weeks ]
   Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.
6. Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) [ Time Frame: 2 weeks ]
   FEV1 and FVC at 30 minutes and 1-hour post dose at week 2 for indacaterol acetate 75 μg and 150 μg o.d.
7. Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score) [ Time Frame: 2 weeks ]
   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).
8. Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days) [ Time Frame: 2 weeks ]
   Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change)

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Belgium

Novartis Investigative Site

Brugge, Belgium, 8000

Novartis Investigative Site

Brussel, Belgium, 1020

Colombia

Novartis Investigative Site

Bogota, Colombia

Novartis Investigative Site

Bucaramanga, Colombia

Croatia

Novartis Investigative Site

Slavonski Brod, Croatia, 35000

Novartis Investigative Site

Zagreb, Croatia, 10000

Germany

Novartis Investigative Site

Hamm, Germany, D 59063

Novartis Investigative Site

Mannheim, Germany, 68161

Novartis Investigative Site

Rosenheim, Germany, 83026

Guatemala

Novartis Investigative Site

Guatemala City, GTM, Guatemala, 01010

Novartis Investigative Site

Guatemala City, Guatemala, 01011

Novartis Investigative Site

Guatemala City, Guatemala, 01015

Hungary

Novartis Investigative Site

Torokbalint, Pest, Hungary, 2045

Novartis Investigative Site

Budapest, Hungary, 1083

Novartis Investigative Site

Szeged, Hungary, 6720

Novartis Investigative Site

Szigetvar, Hungary, 7900

Philippines

Novartis Investigative Site

Manila, Metro Manila, Philippines, 1000

Novartis Investigative Site

Manila, Philippines, 1008

Novartis Investigative Site

Quezon City, Philippines, 1113

Russian Federation

Novartis Investigative Site

Saint Petersburg, Russian Federation, 199106

Novartis Investigative Site

St.Petersburg, Russian Federation, 196240

Slovakia

Novartis Investigative Site

Nitra, Slovak Republic, Slovakia, 949 01

Novartis Investigative Site

Nove Zamky, SVK, Slovakia, 94001

South Africa

Novartis Investigative Site

Middelburg, Mpumalanga, South Africa, 1050

Novartis Investigative Site

Panorama, Western Cape, South Africa, 7500

Novartis Investigative Site

Cape Town, South Africa, 7531

Novartis Investigative Site

Cape Town, South Africa, 7700

Turkey

Novartis Investigative Site

Adana, Turkey, 01330

Novartis Investigative Site

Ankara, Turkey, 06100

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):

Statistical Analysis Plan  [PDF] August 27, 2019

Study Protocol  [PDF] June 28, 2016

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02892019
• Other Study ID Numbers: CQMF149G2202; 2016-002113-21 ( EudraCT Number )
• First Posted: September 8, 2016
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

indacaterol acetate, asthma, GINA 2015, pediatrics

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases