AsthmaPhase 3TRIADESNCT07858123
Safety and Efficacy Comparison Between CHF5993 100/6 12.5µg pMDI to Seretide Evohaler 125/25µg pMDI in Adolescent Subjects With Asthma
A Phase 3 study testing CHF5993 100/6/12.5 μg pMDI HFA-152a and Seretide Evohaler in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 25 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- CHF5993 100/6/12.5 μg pMDI HFA-152a and Seretide Evohaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 16 Nov 2026to 26 Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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;
Who cannot join
- 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)
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- 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.
Trial locations and contacts
25 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 3 countries
Italy12 sites
ASST Spedali Civili Brescia
Brescia
Laura Pini
"A. Perrino" Hospital
Brindisi
Aniello Meoli
Istituto Giannina Gaslini Pediatric Allergic Center,
Genoa
Maria Angela Tosca
University of Messina G. Martino Hospital, Allergy and Clinical Immunology Unit
Messina
Luisa Riccardi
Buzzi Children Hospital
Milan
Michele Ghezzi
Federico II University, Department of Translational Medical Sciences, Section of Pediatrics
Naples
Melissa Borrelli
IPAS (Respiratory Diseases of Pediatric Interest) University of Campania 'Luigi Vanvitelli',
Naples
Michele Miraglia del Giudice
University Hospital of Parma
Parma
Susanna Maria Roberta Esposito
University Hospital of Pisa, Pediatrics Unit
Pisa
Maria Elisa di Cicco
Fondazione Policlinico Universitario A. Gemelli IRCCS, Department of Woman and Child Health and Public Health
Roma
Roberta Onesimo
Bambino Gesù Pediatric Hospital IRCCS, Allergy Division
Rome
Alessandro Fiocchi
IRCCS Humanitas Research Hospital
Rozzano
Enrico Heffler
Spain9 sites
Hospital Universitario Germans Trias
Badalona
Albert Roger Reig
Hospital Sant Joan de Deu
Barcelona
Jaime Lozano Blasco
Vall d'Hebron University Hospital
Barcelona
Teresa Garriga-Baraut
Hospital General Universitario Santa Lucia
Cartagena
Jose Valverde Molina
Hospital Universitario De Jerez Servicio de Pediatría
Jerez de la Frontera
David Gomez Pastrana
Hospital Universitario Infanta Leonor
Madrid
Maria Vazquez de la Torre Gaspar
Hospital Universitario Severo Ochoa
Madrid
Sergio Quevedo Teruel
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Carlos Garcia Magan
IMED Valencia
Valencia
Noelia Colomer Hernadez
Germany4 sites
Institute for Respiratory Diseases Medaimun GmbH
Frankfurt
Stefan Zielen
Georg-August-Universität Göttingen
Göttingen
Christiane Lex
Universitätsklinikum Jena
Jena
Michael Lorenz
Centre for Congenital Heart Defects Stuttgart, Paediatric Intensive Care, Pulmonology and Allergology
Stuttgart
Marcus Rose
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- CHF5993 100/6/12.5 μg pMDI HFA-152a, Seretide Evohaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF5993 100/6/12.5 μg pMDI HFA-152aDrug
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.
Seretide EvohalerDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Inhaler CHF5993 100/6/12,5μg pMDI | Experimental | Not described Receives: Drug: CHF5993 100/6/12.5 μg pMDI HFA-152a |
| Seretide Evohaler FP/SLM pMDI 125/25μg | Active comparator | Not described Receives: Drug: Seretide Evohaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pre-dose Forced Expiratory Volume FEV1 in the first second (FEV1).
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
Measured: Baseline (pre-dose on Week 0) and Week 26
Secondary outcomes (11)
Change from baseline in 2h post-dose FEV1
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
Measured: Baseline (pre-dose on Week 0) and Week 26
Evaluation of Severe asthma exacerbations rate over the 52 weeks of treatment
Measured: Over the 52 weeks of treatment
Time to first severe exacerbation during the entire 52 weeks of treatment
Measured: 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)
The 7-item Asthma Control Questionnaire (ACQ-7) score ranges from 0 to 6, with higher scores indicating worse asthma control.
Measured: 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
The Asthma Quality of Life Questionnaire (AQLQ) score ranges from 1 to 7, with higher scores indicating better asthma-related quality of life.
Measured: Baseline (pre-dose on Week 0) and Week 12, Week 26, Week 52
Change from baseline in pre-dose FEV1 at all clinical visits
Measured: Baseline (pre-dose on Week 0) and applicable clinical visits
Change from baseline in 2h post-dose FEV1 at all clinical visits
Measured: 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)
Measured: 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
Measured: 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)
The 5-item Asthma Control Questionnaire (ACQ-5) score ranges from 0 to 6, with higher scores indicating worse asthma control.
Measured: 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)
Measured: Baseline (pre-dose on Week 0) and Over the 52 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start16 Nov 2026 (estimated)
- Primary completion26 Jun 2030 (estimated)
- Study completion26 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind multicenter, randomized, active-controlled, 2-arm, parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Zielen, MD, Principal investigator, Institut für Atemwegserkrankungen Medaimun GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858123
- Sponsor's protocol ID
- CLI-05993AA5-06
- Other IDs
- 2024-514248-95-00
- Acronym
- TRIADES
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07858123
- Acronym / sponsor ID
- TRIADES / CLI-05993AA5-06
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 26 Jun 2030 (estimated)
- Study completion
- 26 Jun 2030 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind multicenter, randomized, active-controlled, 2-arm, parallel-group
| Arm | Type | Receives |
|---|---|---|
| Inhaler CHF5993 100/6/12,5μg pMDI | Experimental | Drug: CHF5993 100/6/12.5 μg pMDI HFA-152a |
| Seretide Evohaler FP/SLM pMDI 125/25μg | Active comparator | Drug: Seretide Evohaler |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF5993 100/6/12.5 μg pMDI HFA-152aDrug: 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. | Drug | Inhaler CHF5993 100/6/12,5μg pMDI |
| Seretide EvohalerDrug: 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. | Drug | Seretide Evohaler FP/SLM pMDI 125/25μg |
Primary outcome
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
11 secondary outcomes
Change from baseline in 2h post-dose FEV1
Time frame: 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
Time to first severe exacerbation during the entire 52 weeks of treatment
Time frame: 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
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
Change from baseline in pre-dose FEV1 at all clinical visits
Time frame: 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
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
Change from baseline in 48h post-dose morning FEV1 after the last intake of study treatment at Week 52
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Zielen, MD principal investigator
Institut für Atemwegserkrankungen Medaimun GmbH
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHF5993 100/6/12.5 μg pMDI HFA-152a and Seretide Evohaler in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiesi Clinical Trial Info (+39 0521 2791, clinicaltrials_info@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.