MedDataX Logo

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

NCT ID: NCT02892019

Last Updated: 2020-01-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2019-07-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.

NCT03257995

Asthma
COMPLETED PHASE2

Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma

NCT00927901

Asthma
COMPLETED PHASE2

Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma

NCT00529529

Asthma
COMPLETED PHASE3

Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma

NCT01959412

Asthma
COMPLETED PHASE2

Efficacy and Safety of Different Doses of Indacaterol

NCT01079130

Asthma
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Indacaterol acetate 75 μg o.d.

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

Group Type ACTIVE_COMPARATOR

Indacaterol acetate 75 μg

Intervention Type DRUG

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

Indacaterol acetate 150 μg o.d.

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

Group Type ACTIVE_COMPARATOR

Indacaterol acetate 150 μg

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Indacaterol acetate 75 μg

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

Intervention Type DRUG

Indacaterol acetate 150 μg

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

QAB149 QAB149

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Bruges, , Belgium

Site Status

Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Bogotá, , Colombia

Site Status

Novartis Investigative Site

Bucaramanga, , Colombia

Site Status

Novartis Investigative Site

Slavonski Brod, , Croatia

Site Status

Novartis Investigative Site

Zagreb, , Croatia

Site Status

Novartis Investigative Site

Hamm, , Germany

Site Status

Novartis Investigative Site

Mannheim, , Germany

Site Status

Novartis Investigative Site

Rosenheim, , Germany

Site Status

Novartis Investigative Site

Guatemala City, GTM, Guatemala

Site Status

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status

Novartis Investigative Site

Törökbálint, Pest County, Hungary

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Szeged, , Hungary

Site Status

Novartis Investigative Site

Szigetvár, , Hungary

Site Status

Novartis Investigative Site

Manila, National Capital Region, Philippines

Site Status

Novartis Investigative Site

Manila, , Philippines

Site Status

Novartis Investigative Site

Quezon City, , Philippines

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Nitra, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Nové Zámky, SVK, Slovakia

Site Status

Novartis Investigative Site

Middelburg, Mpumalanga, South Africa

Site Status

Novartis Investigative Site

Panorama, Western Cape, South Africa

Site Status

Novartis Investigative Site

Cape Town, , South Africa

Site Status

Novartis Investigative Site

Cape Town, , South Africa

Site Status

Novartis Investigative Site

Adana, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Colombia Croatia Germany Guatemala Hungary Philippines Russia Slovakia South Africa Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37682405 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-002113-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQMF149G2202

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
NCT00624702 COMPLETED PHASE1
A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
NCT01484197 COMPLETED PHASE2
Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
NCT01156844 COMPLETED PHASE2
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
NCT00605306 COMPLETED PHASE2
Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
NCT01609478 COMPLETED PHASE2
Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma
NCT00556673 COMPLETED PHASE2
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
NCT01012739 COMPLETED PHASE2
ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
NCT07301255 RECRUITING PHASE2
A Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture
NCT01845623 WITHDRAWN PHASE2
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma
NCT00545272 COMPLETED PHASE2
Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
NCT00112411 COMPLETED PHASE2
A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma
NCT05562466 RECRUITING PHASE3
Safety and Efficacy of Berodual® Inhaled Via Respimat® Compared to MDI (Metered Dose Inhaler) in Pediatric Patients With Asthma
NCT02182505 COMPLETED PHASE3
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma
NCT05222529 RECRUITING PHASE2
Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma
NCT00557440 COMPLETED PHASE2
Advair Pediatric Once-Daily
NCT00920959 COMPLETED PHASE3
Phase 2a Study to Assess the Efficacy and Safety of AZD4604 in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA
NCT06020014 COMPLETED PHASE2
A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics
NCT02126839 COMPLETED PHASE3
Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma
NCT00746330 COMPLETED PHASE2
A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic Subjects
NCT03622112 COMPLETED PHASE2
Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation
NCT04705727 TERMINATED PHASE3
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
NCT03226392 COMPLETED PHASE3
Comparison of Mesh Nebulizer and Compressor Nebulizer With Pulmonary Function Test in Pediatric Asthma Attacks
NCT06211998 COMPLETED NA
A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma
NCT01641692 COMPLETED PHASE2
A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
NCT05776927 NOT_YET_RECRUITING PHASE3