Safety and Efficacy Comparison Between CHF5993 100/6 12.5µg pMDI to Seretide Evohaler 125/25µg pMDI in Adolescent Subjects With Asthma (TRIADES)
2 de octubre de 2026 actualizado por: Chiesi Farmaceutici S.p.A.
A 52-Week, Randomised, Double-Blind, Double-Dummy, Multinational, Multicenter, Active-Controlled, 2-Arm Parallel Group Study Comparing CHF5993 100/6/12.5 μg pMDI (Fixed Combination of Extrafine Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to Seretide® Evohaler® 125/25 μg pMDI (Fixed Combination of Fluticasone Propionate/Salmeterol Xinafoate) in Adolescent Subjects With Uncontrolled Asthma on Medium Doses of Inhaled Corticosteroids in Combination With Long-Acting β2-Agonists
The CLI-05993AA5-06 study is an interventional study designed to investigate the safety and efficacy of a new experimental drug called CHF5993 pMDI compared to the currently approved Seretide 125 Evohaler pMDI in adolescent patients with uncontrolled asthma.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Outpatients attending the hospital clinics/study centers will be recruited. Uncontrolled asthma adolescent subjects will be recruited. A total of 420 subjects will be randomized. The whole study will last approximately 52 weeks for each subject.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
700
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Chiesi Clinical Trial Info
- Número de teléfono: +39 0521 2791
- Correo electrónico: clinicaltrials_info@chiesi.com
Ubicaciones de estudio
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Frankfurt, Alemania
- Institute for Respiratory Diseases Medaimun GmbH
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Contacto:
- Stefan Zielen
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Göttingen, Alemania
- Georg-August-Universität Göttingen
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Contacto:
- Christiane Lex
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Jena, Alemania
- Universitätsklinikum Jena
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Contacto:
- Michael Lorenz
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Stuttgart, Alemania
- Centre for Congenital Heart Defects Stuttgart, Paediatric Intensive Care, Pulmonology and Allergology
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Contacto:
- Marcus Rose
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Badalona, España
- Hospital Universitario Germans Trias
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Contacto:
- Albert Roger Reig
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Barcelona, España
- Vall d'Hebron University Hospital
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Contacto:
- Teresa Garriga-Baraut
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Barcelona, España
- Hospital Sant Joan de Deu
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Contacto:
- Jaime Lozano Blasco
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Cartagena, España
- Hospital General Universitario Santa Lucia
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Contacto:
- Jose Valverde Molina
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Jerez de la Frontera, España
- Hospital Universitario De Jerez Servicio de Pediatría
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Contacto:
- David Gomez Pastrana
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Madrid, España
- Hospital Universitario Infanta Leonor
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Contacto:
- Maria Vazquez de la Torre Gaspar
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Madrid, España
- Hospital Universitario Severo Ochoa
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Contacto:
- Sergio Quevedo Teruel
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Santiago de Compostela, España
- Hospital Clínico Universitario de Santiago de Compostela
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Contacto:
- Carlos Garcia Magan
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Valencia, España
- IMED Valencia
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Contacto:
- Noelia Colomer Hernadez
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Brescia, Italia
- ASST Spedali Civili Brescia
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Contacto:
- Laura Pini
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Brindisi, Italia
- "A. Perrino" Hospital
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Contacto:
- Aniello Meoli
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Genoa, Italia
- Istituto Giannina Gaslini Pediatric Allergic Center,
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Contacto:
- Maria Angela Tosca
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Messina, Italia
- University of Messina G. Martino Hospital, Allergy and Clinical Immunology Unit
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Contacto:
- Luisa Riccardi
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Milan, Italia
- Buzzi Children Hospital
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Contacto:
- Michele Ghezzi
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Naples, Italia
- Federico II University, Department of Translational Medical Sciences, Section of Pediatrics
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Contacto:
- Melissa Borrelli
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Naples, Italia
- IPAS (Respiratory Diseases of Pediatric Interest) University of Campania 'Luigi Vanvitelli',
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Contacto:
- Michele Miraglia del Giudice
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Parma, Italia
- University Hospital of Parma
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Contacto:
- Susanna Maria Roberta Esposito
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Pisa, Italia
- University Hospital of Pisa, Pediatrics Unit
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Contacto:
- Maria Elisa di Cicco
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Roma, Italia
- Fondazione Policlinico Universitario A. Gemelli IRCCS, Department of Woman and Child Health and Public Health
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Contacto:
- Roberta Onesimo
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Rome, Italia
- Bambino Gesù Pediatric Hospital IRCCS, Allergy Division
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Contacto:
- Alessandro Fiocchi
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Rozzano, Italia
- IRCCS Humanitas Research Hospital
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Contacto:
- Enrico Heffler
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subject's written informed consent obtained prior to any study related procedure;
- Male and female adolescent aged ≥ 12 and <18 years;
- Subject participating in the Pharmacokinetic(s) (PK) part of the study, body weight should be ≥ 30kg
- A documented history of asthma for at least 6 months
- Subjects in treatment with double therapy with medium doses of inhaled corticosteroids (ICS) in fixed or free combination with a long-acting β2-agonist (LABA) ( > 500-1000 μg daily dose Beclomethasone Dipropionate non-extrafine or estimated clinically comparable dose plus formoterol 24 µg/day or salmeterol 100 µg/day or vilanterol 25 µg/day) at a stable dose for at least 4 weeks prior to screening;
- Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read/write, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved.
- Subjects with a pre-Bronchodilator (BD) Forced Expiratory Volume in the first second (FEV1) ≤90% and ≥60% of their predicted normal value, after appropriate washout from BDs, at the Screening and Randomization Visits
- Subjects with a positive response to a reversibility test at screening, defined as FEV1 ≥12% and ≥200 mL over baseline, 10 to 15 minutes (min) after inhaling 200-400 µg of salbutamol pMDI.
- Subjects with uncontrolled asthma evidenced by an ACQ-7 total score ≥1.5 at screening;
- A documented history of one or more asthma exacerbations requiring treatment with systemic corticosteroids (SCS) or emergency department visit or in-patient hospitalization in the previous 12 months;
Exclusion Criteria:
- History of "at risk" asthma: history of near fatal asthma or of a past hospitalization for asthma in an intensive care unit which, in the judgement of the Investigator, may place the subject at undue risk;
- Recent exacerbation or respiratory tract infection: hospitalization, emergency room admission or use of SCS for an asthma exacerbation or a documented diagnosis of lower respiratory tract infection that required antibiotics or an unresolved respiratory tract infection within 4 weeks prior to Screening Visit (V1) or during the run-in period;
- Respiratory disorders other than asthma: this can include but is not limited to: α1-antitrypsin deficiency, active tuberculosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary hypertension and interstitial lung disease;
- Current smokers (including e-cigarettes, vaping and hookah), or ex-smokers with a smoking history of ≥5 pack-years (pack-years = the number of cigarette packs per day times the number of years), or current use of inhaled or oral cannabis products. Ex-smokers must have stopped smoking ≥1 year (≥6 months for e-cigarettes);
- Other severe acute or chronic medical (such as but not limited to thyrotoxicosis, diabetes mellitus, and untreated hypokalemia) or malignancy or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study;
- Any change in dose, schedule or formulation of the combination ICS plus LABA in the 4 weeks prior to Screening Visit (V1)
- Subjects using SCS medication in the 4 weeks or slow-release corticosteroids in the 12 weeks, prior to screening
- Only for subjects included in the subset for PK assessment:
Veins unsuitable for repeated venipuncture; Blood donation or blood loss (>450 mL) in the 4 weeks before randomization.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Inhaler CHF5993 100/6/12,5μg pMDI
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Drug: CHF5993 100/6/12.5 μg pMDI HFA-152a administered via Pressurized Metered Dose Inhaler (pMDI). Active ingredients: Beclomethasone Dipropionate (BDP)//Formoterol Fumarate (FF) /Glycopyrronium Bromide (GB) 100/6/12,5μg per actuation; Excipients: HFA-152a propellant. |
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Comparador activo: Seretide Evohaler FP/SLM pMDI 125/25μg
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Drug: Seretide Evohaler administered via Pressurized Metered Dose Inhaler (pMDI). Active ingredients: Fluticasone Propionate (FP)/Salmeterol Xinafoate (SLM) pMDI 125/25μg per actuation; Excipients: HFA-134a propellant. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in pre-dose Forced Expiratory Volume FEV1 in the first second (FEV1).
Periodo de tiempo: Baseline (pre-dose on Week 0) and Week 26
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Population summary measure is the adjusted mean between treatment difference comparing CHF5993 BDP/FF/GB pMDI vs. Seretide® Evohaler® FP/SLM pMDI in a Intent To Treat (ITT) Population to demonstrate the superiority of CHF5993 BDP/FF/GB pMDI compared to Seretide Evohaler FP/SLM pMDI |
Baseline (pre-dose on Week 0) and Week 26
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in 2h post-dose FEV1
Periodo de tiempo: Baseline (pre-dose on Week 0) and Week 26
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Population summary measure is the adjusted mean between treatment difference comparing CHF5993 BDP/FF/GB pMDI vs. Seretide® Evohaler® FP/SLM pMDI in ITT population to demonstrate the superiority of CHF5993 BDP/FF/GB pMDI compared to Seretide Evohaler FP/SLM pMDI |
Baseline (pre-dose on Week 0) and Week 26
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Evaluation of Severe asthma exacerbations rate over the 52 weeks of treatment
Periodo de tiempo: Over the 52 weeks of treatment
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Over the 52 weeks of treatment
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Time to first severe exacerbation during the entire 52 weeks of treatment
Periodo de tiempo: Over the 52 weeks of treatment
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Over the 52 weeks of treatment
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Change from baseline in the 7-item Asthma Control Questionnaire (ACQ-7) at Week 12, Week 26 and Week 52 during study visits (using centralized spirometry)
Periodo de tiempo: Baseline (pre-dose on Week 0) and Week 12, Week 26, Week 52
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The 7-item Asthma Control Questionnaire (ACQ-7) score ranges from 0 to 6, with higher scores indicating worse asthma control. |
Baseline (pre-dose on Week 0) and Week 12, Week 26, Week 52
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Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) at Week 12, Week 26 and Week 52 during study visits
Periodo de tiempo: Baseline (pre-dose on Week 0) and Week 12, Week 26, Week 52
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The Asthma Quality of Life Questionnaire (AQLQ) score ranges from 1 to 7, with higher scores indicating better asthma-related quality of life. |
Baseline (pre-dose on Week 0) and Week 12, Week 26, Week 52
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Change from baseline in pre-dose FEV1 at all clinical visits
Periodo de tiempo: Baseline (pre-dose on Week 0) and applicable clinical visits
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Baseline (pre-dose on Week 0) and applicable clinical visits
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Change from baseline in 2h post-dose FEV1 at all clinical visits
Periodo de tiempo: Baseline (pre-dose on Week 0) and all applicable clinical visits
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Baseline (pre-dose on Week 0) and all applicable clinical visits
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Proportion of subjects classified as responders in terms of pre-dose FEV1 at Week 26 and Week 52 (i.e., subjects with change from baseline in pre-dose FEV1 ≥100 mL)
Periodo de tiempo: Baseline (pre-dose on Week 0) and Week 26, Week 52
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Baseline (pre-dose on Week 0) and Week 26, Week 52
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Change from baseline in 48h post-dose morning FEV1 after the last intake of study treatment at Week 52
Periodo de tiempo: Week 52
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Week 52
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Change from baseline in weekly 5-item Asthma Control Questionnaire (ACQ-5) over the 52 weeks of treatment (performed at home by the subject)
Periodo de tiempo: Baseline (pre-dose on Week 0) and over the 52 weeks of treatment
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The 5-item Asthma Control Questionnaire (ACQ-5) score ranges from 0 to 6, with higher scores indicating worse asthma control. |
Baseline (pre-dose on Week 0) and over the 52 weeks of treatment
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Change from baseline in home spirometry parameters (e.g. FEV1, Forced Vital Capacity) over the 52 weeks of treatment (performed at home by the subject)
Periodo de tiempo: Baseline (pre-dose on Week 0) and Over the 52 weeks of treatment
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Baseline (pre-dose on Week 0) and Over the 52 weeks of treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Stefan Zielen, MD, Institut für Atemwegserkrankungen Medaimun GmbH
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
16 de noviembre de 2026
Finalización primaria (Estimado)
26 de junio de 2030
Finalización del estudio (Estimado)
26 de junio de 2030
Fechas de registro del estudio
Enviado por primera vez
18 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de octubre de 2026
Publicado por primera vez (Actual)
5 de octubre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de octubre de 2026
Última verificación
1 de octubre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CLI-05993AA5-06
- 2024-514248-95-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .