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

NCT02892019 | Completed Phase 2 Results

• 2 other identifiers: CQMF149G22022016-002113-21
• Study Type: interventional
• Target: 79
• Locations: 11 countries
• Sites: 29

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.

Conditions

Asthma

Keywords

indacaterol acetate, asthma, GINA 2015, pediatrics

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (8)

• Systemic Exposure to Indacaterol in Plasma

  day 1, day 14

• Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire

  2 weeks

• Pre-dose Morning and Evening Peak Expiratoty Flow (PEF)

  2 weeks

• Rescue Medication Usage (Mean Daiily Number of Puffs)

  2 weeks

• Rescue Medication Usage (Percentage of Rescue Medication Free Days)

  2 weeks

Study Arms (2)

Indacaterol acetate 75 μg o.d.

ACTIVE COMPARATOR

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

Drug: Indacaterol acetate 75 μg

Indacaterol acetate 150 μg o.d.

ACTIVE COMPARATOR

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

Drug: Indacaterol acetate 150 μg

Interventions

Indacaterol acetate 75 μg DRUG

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

Also known as: QAB149

Indacaterol acetate 75 μg o.d.

Indacaterol acetate 150 μg DRUG

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

Also known as: QAB149

Indacaterol acetate 150 μg o.d.

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (29)

Novartis Investigative Site

Bruges, 8000, Belgium

Location

Novartis Investigative Site

Brussels, 1020, Belgium

Location

Novartis Investigative Site

Bogotá, Colombia

Location

Novartis Investigative Site

Bucaramanga, Colombia

Location

Novartis Investigative Site

Slavonski Brod, 35000, Croatia

Location

Novartis Investigative Site

Zagreb, 10000, Croatia

Location

Novartis Investigative Site

Hamm, D 59063, Germany

Location

Novartis Investigative Site

Mannheim, 68161, Germany

Location

Novartis Investigative Site

Rosenheim, 83026, Germany

Location

Novartis Investigative Site

Guatemala City, GTM, 01010, Guatemala

Location

Novartis Investigative Site

Guatemala City, 01011, Guatemala

Location

Novartis Investigative Site

Guatemala City, 01015, Guatemala

Location

Novartis Investigative Site

Törökbálint, Pest County, 2045, Hungary

Location

Novartis Investigative Site

Budapest, 1083, Hungary

Location

Novartis Investigative Site

Szeged, 6720, Hungary

Location

Novartis Investigative Site

Szigetvár, 7900, Hungary

Location

Novartis Investigative Site

Manila, National Capital Region, 1000, Philippines

Location

Novartis Investigative Site

Manila, 1008, Philippines

Location

Novartis Investigative Site

Quezon City, 1113, Philippines

Location

Novartis Investigative Site

Saint Petersburg, 196240, Russia

Location

Novartis Investigative Site

Saint Petersburg, 199106, Russia

Location

Novartis Investigative Site

Nitra, Slovak Republic, 949 01, Slovakia

Location

Novartis Investigative Site

Nové Zámky, SVK, 94001, Slovakia

Location

Novartis Investigative Site

Middelburg, Mpumalanga, 1050, South Africa

Location

Novartis Investigative Site

Panorama, Western Cape, 7500, South Africa

Location

Novartis Investigative Site

Cape Town, 7531, South Africa

Location

Novartis Investigative Site

Cape Town, 7700, South Africa

Location

Novartis Investigative Site

Adana, 01330, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Sekerel BE, Nell H, Laki I, Pak T, Contreras E, Kolarz A, D'Andrea P, Manga V, Jain M, Vaidya S, Valentin M, Sen B. Efficacy, Safety, and Systemic Exposure of Once-Daily Indacaterol Acetate in Pediatric Asthma: A Randomized, Double-Blind, Controlled Dose-Finding Study. Clin Drug Investig. 2023 Sep;43(9):719-728. doi: 10.1007/s40261-023-01300-8. Epub 2023 Sep 8.

  PMID: 37682405 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

indacaterol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 8, 2016
• Study Start: April 18, 2017
• Primary Completion: June 19, 2019
• Study Completion: July 17, 2019
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Locations

RU (2); CR (2); GU (3); BE (2); SL (2); TU (2); CO (2); DE (3); HU (4); ZA (4); PH (3)