Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Safety and Efficacy Comparison Between CHF5993 100/6 12.5µg pMDI to Seretide Evohaler 125/25µg pMDI in Adolescent Subjects With Asthma (TRIADES)

2 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

700

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Frankfurt, Allemagne
        • Institute for Respiratory Diseases Medaimun GmbH
        • Contact:
          • Stefan Zielen
      • Göttingen, Allemagne
        • Georg-August-Universität Göttingen
        • Contact:
          • Christiane Lex
      • Jena, Allemagne
        • Universitätsklinikum Jena
        • Contact:
          • Michael Lorenz
      • Stuttgart, Allemagne
        • Centre for Congenital Heart Defects Stuttgart, Paediatric Intensive Care, Pulmonology and Allergology
        • Contact:
          • Marcus Rose
  • Espagne
      • Badalona, Espagne
        • Hospital Universitario Germans Trias
        • Contact:
          • Albert Roger Reig
      • Barcelona, Espagne
        • Vall d'Hebron University Hospital
        • Contact:
          • Teresa Garriga-Baraut
      • Barcelona, Espagne
        • Hospital Sant Joan de Deu
        • Contact:
          • Jaime Lozano Blasco
      • Cartagena, Espagne
        • Hospital General Universitario Santa Lucia
        • Contact:
          • Jose Valverde Molina
      • Jerez de la Frontera, Espagne
        • Hospital Universitario De Jerez Servicio de Pediatría
        • Contact:
          • David Gomez Pastrana
      • Madrid, Espagne
        • Hospital Universitario Infanta Leonor
        • Contact:
          • Maria Vazquez de la Torre Gaspar
      • Madrid, Espagne
        • Hospital Universitario Severo Ochoa
        • Contact:
          • Sergio Quevedo Teruel
      • Santiago de Compostela, Espagne
        • Hospital Clínico Universitario de Santiago de Compostela
        • Contact:
          • Carlos Garcia Magan
      • Valencia, Espagne
        • IMED Valencia
        • Contact:
          • Noelia Colomer Hernadez
  • Italie
      • Brescia, Italie
        • ASST Spedali Civili Brescia
        • Contact:
          • Laura Pini
      • Brindisi, Italie
        • "A. Perrino" Hospital
        • Contact:
          • Aniello Meoli
      • Genoa, Italie
        • Istituto Giannina Gaslini Pediatric Allergic Center,
        • Contact:
          • Maria Angela Tosca
      • Messina, Italie
        • University of Messina G. Martino Hospital, Allergy and Clinical Immunology Unit
        • Contact:
          • Luisa Riccardi
      • Milan, Italie
        • Buzzi Children Hospital
        • Contact:
          • Michele Ghezzi
      • Naples, Italie
        • Federico II University, Department of Translational Medical Sciences, Section of Pediatrics
        • Contact:
          • Melissa Borrelli
      • Naples, Italie
        • IPAS (Respiratory Diseases of Pediatric Interest) University of Campania 'Luigi Vanvitelli',
        • Contact:
          • Michele Miraglia del Giudice
      • Parma, Italie
        • University Hospital of Parma
        • Contact:
          • Susanna Maria Roberta Esposito
      • Pisa, Italie
        • University Hospital of Pisa, Pediatrics Unit
        • Contact:
          • Maria Elisa di Cicco
      • Roma, Italie
        • Fondazione Policlinico Universitario A. Gemelli IRCCS, Department of Woman and Child Health and Public Health
        • Contact:
          • Roberta Onesimo
      • Rome, Italie
        • Bambino Gesù Pediatric Hospital IRCCS, Allergy Division
        • Contact:
          • Alessandro Fiocchi
      • Rozzano, Italie
        • IRCCS Humanitas Research Hospital
        • Contact:
          • Enrico Heffler

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Inhaler CHF5993 100/6/12,5μg pMDI
Médicament: CHF5993 100/6/12.5 μg pMDI HFA-152a

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.
Comparateur actif: Seretide Evohaler FP/SLM pMDI 125/25μg
Médicament: Seretide Evohaler

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in pre-dose Forced Expiratory Volume FEV1 in the first second (FEV1).
Délai: Baseline (pre-dose on Week 0) and Week 26

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline in 2h post-dose FEV1
Délai: Baseline (pre-dose on Week 0) and Week 26

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
Evaluation of Severe asthma exacerbations rate over the 52 weeks of treatment
Délai: Over the 52 weeks of treatment
Over the 52 weeks of treatment
Time to first severe exacerbation during the entire 52 weeks of treatment
Délai: Over the 52 weeks of treatment
Over the 52 weeks of treatment
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)
Délai: Baseline (pre-dose on Week 0) and Week 12, Week 26, Week 52

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
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) at Week 12, Week 26 and Week 52 during study visits
Délai: Baseline (pre-dose on Week 0) and Week 12, Week 26, Week 52

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
Change from baseline in pre-dose FEV1 at all clinical visits
Délai: Baseline (pre-dose on Week 0) and applicable clinical visits
Baseline (pre-dose on Week 0) and applicable clinical visits
Change from baseline in 2h post-dose FEV1 at all clinical visits
Délai: Baseline (pre-dose on Week 0) and all applicable clinical visits
Baseline (pre-dose on Week 0) and all applicable clinical visits
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)
Délai: Baseline (pre-dose on Week 0) and Week 26, Week 52
Baseline (pre-dose on Week 0) and Week 26, Week 52
Change from baseline in 48h post-dose morning FEV1 after the last intake of study treatment at Week 52
Délai: Week 52
Week 52
Change from baseline in weekly 5-item Asthma Control Questionnaire (ACQ-5) over the 52 weeks of treatment (performed at home by the subject)
Délai: Baseline (pre-dose on Week 0) and over the 52 weeks of treatment

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
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)
Délai: Baseline (pre-dose on Week 0) and Over the 52 weeks of treatment
Baseline (pre-dose on Week 0) and Over the 52 weeks of treatment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chiesi Farmaceutici S.p.A.

Les enquêteurs

  • Chercheur principal: Stefan Zielen, MD, Institut für Atemwegserkrankungen Medaimun GmbH

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

16 novembre 2026

Achèvement primaire (Estimé)

26 juin 2030

Achèvement de l'étude (Estimé)

26 juin 2030

Dates d'inscription aux études

Première soumission

18 septembre 2026

Première soumission répondant aux critères de contrôle qualité

2 octobre 2026

Première publication (Réel)

5 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CLI-05993AA5-06
  • 2024-514248-95-00 (Ctis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner