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.
Asthma
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 12 años - 17 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 188 Estimado
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Acerca de la investigación
The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.
Leer la descripción completa
This is a double-dummy, double-blind, randomized, active controlled, two-way two-period treatment (12 weeks duration each) cross-over study.
The study duration of 36 weeks includes:
- a screening period of up to 15 days (rescue medication: short acting β2-agonist (SABA) salbutamol 100 μg or albuterol 90 μg via a Metered-Dose Inhaler (MDI) to use as-needed throughout the study).
- a run-in period of 14 days (run-in medication: salmeterol xinafoate 50 μg / fluticasone propionate 250μg bid delivered via Girohaler® or equivalent DPI device)
- two treatment period of 12 weeks each (either QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 µg bid, or salmeterol xinafoate/fluticasone propionate 50/500 µg bid and placebo to QVM149 150/50/160 µg od, separated by a 3 week washout period (wash-out medication: salmeterol xinafoate/fluticasone propionate 50/250 µg bid)
- a safety follow up period of 30 days during which the participant will be back on standard of care treatment as appropriate.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Key Inclusion criteria:
- Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit
- Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening.
- Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening
- Participants must be symptomatic / inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening
- Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol/180-360 μg albuterol at run-in visit
- Pre-bronchodilator FEV1 ≥ 50% of the predicted normal value for the participant according to American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 criteria at both run-in and before randomization
Key Exclusion criteria:
- Participants who have had a severe asthma attack/exacerbation requiring systemic steroids OR hospitalization (\> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation
- Participants who have ever required intubation for a severe asthma attack/exacerbation
- Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis
- Participants with Type I diabetes or uncontrolled Type II diabetes
- Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in
- Participants with a history of myocardial infarction (this should be confirmed clinically by the Investigator) within the previous 12 months
- Participants with a history of long QT syndrome or a family history of a first degree relative with sudden cardiac death under the age of 50 years, or participants whose QTc measured at run-in or at baseline (prior to randomization) (Fridericia method) is prolonged (\> 450 msec for males and \> 460 msec for females) and confirmed by a central assessor or the inability to determine the QT interval corrected by Fridericia's formula (QTcF) interval (these participants should not be re-screened)
- Female participants of childbearing potential defined as all females physiologically capable of becoming pregnant (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria
- Use of long-acting muscarinic antagonist (LAMA) within 3 months prior to screening
Other protocol-defined inclusion/exclusion criteria may apply.
Entiende la evaluación inicialTratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate
- QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1.
- Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2.
Drug: QVM149 · Drug: Salmeterol Xinafoate / Fluticasone Propionate · Drug: Placebo to QVM149 · Drug: Placebo to salmeterol xinafoate / fluticasone propionate
Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149
- Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1.
- Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2.
Drug: QVM149 · Drug: Salmeterol Xinafoate / Fluticasone Propionate · Drug: Placebo to QVM149 · Drug: Placebo to salmeterol xinafoate / fluticasone propionate
QVM149 DRUG
QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
Salmeterol Xinafoate / Fluticasone Propionate DRUG
Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
Placebo to QVM149 DRUG
Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
Placebo to salmeterol xinafoate / fluticasone propionate DRUG
Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change from Baseline in Trough FEV1
Plazo: Baseline, Week 12 of each treatment period.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Medidas secundarias
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score
Plazo: Baseline, Week 12 of each treatment period
The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score range from 0 to 6. Higher scores indicates worsening of condition.
Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score
Plazo: Baseline, Week 12 of each treatment period
Pediatric Asthma Quality of Life Questionnaire is a 23-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with 7-point scale (7-not bothered at all, 1-extremely bothered). It consists of 3 domains: symptoms, activity limitation and emotional function. Higher scores indicate less impairment in HRQOL.
The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.
Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)
Plazo: Baseline, Week 12 of each treatment period
Rescue medication use over 12 weeks of each treatment period.
Number and severity of reported asthma exacerbations
Plazo: Baseline, Week 12 of each treatment period
Asthma exacerbations over 12 weeks of each treatment period
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Plazo: From first dose up to 30 days after last dose (up to 31 weeks)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (27)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
27 centros
Novartis Investigative SiteRosario, Santa Fe Province, ArgentinaReclutando
Novartis Investigative SiteStrasbourg, FranceReclutando
Novartis Investigative SiteWesel, North Rhine-Westphalia, GermanyReclutando
Novartis Investigative SiteBielefeld, GermanyReclutando
Novartis Investigative SiteSzeged, HungaryReclutando
Novartis Investigative SiteTarnów, Poland, PolandReclutando
Novartis Investigative SiteBialystok, PolandReclutando
Novartis Investigative SiteKrakow, PolandReclutando
Novartis Investigative SiteLublin, PolandReclutando
Novartis Investigative SitePiaseczno, PolandReclutando
Novartis Investigative SiteTorun, PolandReclutando
Novartis Investigative SiteBucharest, RomaniaReclutando
Novartis Investigative SiteBratislava, Mestska Cast Ruzinov, SlovakiaReclutando
Novartis Investigative SiteBanská Bystrica, SlovakiaReclutando
Novartis Investigative SiteBratislava, SlovakiaReclutando
Novartis Investigative SiteKošice, SlovakiaReclutando
Novartis Investigative SiteEast London, Eastern Cape, South AfricaReclutando
Novartis Investigative SiteGermiston, Gauteng, South AfricaReclutando
Novartis Investigative SiteKrugersdorp, Gauteng, South AfricaReclutando
Novartis Investigative SiteLenasia, Gauteng, South AfricaReclutando
Novartis Investigative SitePaarl, Western Cape, South AfricaReclutando
Novartis Investigative SiteCape Town, South AfricaReclutando
Novartis Investigative SitePretoria, South AfricaReclutando
Novartis Investigative SiteSantiago Compostela, A Coruna, SpainReclutando
Novartis Investigative SiteSabadell, Barcelona, SpainReclutando
Novartis Investigative SiteSeville, SpainReclutando
Novartis Investigative SiteKaohsiung City, TaiwanReclutando
Equipo y fechas
- Patrocinador principal
- Novartis Pharmaceuticals
- Inicio del estudio
- 4 ago 2026 Real
- Finalización primaria
- 30 dic 2028 Estimado
- Finalización del estudio
- 30 ene 2029 Estimado
- Primera publicación
- 20 mar 2023 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026