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

2. oktober 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

700

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Inhaler CHF5993 100/6/12,5μg pMDI
Legemiddel: 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.
Aktiv komparator: Seretide Evohaler FP/SLM pMDI 125/25μg
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in pre-dose Forced Expiratory Volume FEV1 in the first second (FEV1).
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in 2h post-dose FEV1
Tidsramme: 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
Tidsramme: Over the 52 weeks of treatment
Over the 52 weeks of treatment
Time to first severe exacerbation during the entire 52 weeks of treatment
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chiesi Farmaceutici S.p.A.

Etterforskere

  • Hovedetterforsker: Stefan Zielen, MD, Institut für Atemwegserkrankungen Medaimun GmbH

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

16. november 2026

Primær fullføring (Antatt)

26. juni 2030

Studiet fullført (Antatt)

26. juni 2030

Datoer for studieregistrering

Først innsendt

18. september 2026

Først innsendt som oppfylte QC-kriteriene

2. oktober 2026

Først lagt ut (Faktiske)

5. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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