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

October 2, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Inhaler CHF5993 100/6/12,5μg pMDI
Drug: 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.
Active Comparator: Seretide Evohaler FP/SLM pMDI 125/25μg
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in pre-dose Forced Expiratory Volume FEV1 in the first second (FEV1).
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in 2h post-dose FEV1
Time Frame: 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
Time Frame: Over the 52 weeks of treatment
Over the 52 weeks of treatment
Time to first severe exacerbation during the entire 52 weeks of treatment
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chiesi Farmaceutici S.p.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan Zielen, MD, Institut für Atemwegserkrankungen Medaimun GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLI-05993AA5-06
  • 2024-514248-95-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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