AsthmaPhase 3TRICHECONCT07546981
Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists
A Phase 3 study testing Experimental: Participant Group CHF 5993 pMDI HFA-152a and Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 2 sites in China.
Trial summary
This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Experimental: Participant Group CHF 5993 pMDI HFA-152a and Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 2 sitesChina
- Study dates
- 26 Jun 2026to 17 Oct 2028
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
- Subjects must provide written informed consent prior to any study-related procedures;
- Subjects must be male or female Chinese aged ≥18 and
- ≤75 years;
- Subjects must have a documented history of asthma for at least 1 year and asthma must have been diagnosed before the subject's age of 40;
- Subjects must have uncontrolled asthma, receiving double therapy only on medium doses of ICS in combination with LABA at a stable dose for at least 4 weeks prior to screening;
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- Subjects must have a pre-bronchodilator FEV1 <80% of their predicted normal value, after appropriate wash out from bronchodilators at the screening visit.
- Subjects must have a positive response to a reversibility test at screening.
- Subjects must have uncontrolled asthma evidenced by a score at the ACQ-7 ≥1.5 (this criterion must be met at screening and at randomisation).
Who cannot join
- Subjects meeting any of the following criteria will be excluded from study enrolment:
- Subjects who have a history of near fatal asthma or of a past hospitalisation for status asthmaticus or severe asthma exacerbation which, in the judgement of the Investigator, may place the subject at undue risk;
- Subjects who have undergone hospitalisation, emergency room visit or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to the screening visit or during the run-in period;
- Subjects with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period;
- Subjects with any change in dose, schedule or formulation of the combination ICS+LABA in the 4 weeks prior to the screening visit;
- Subjects who have used systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks prior to screening;
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- Subjects who have a history of a diagnosis of chronic obstructive pulmonary disease (COPD) (according to the Global Initiative for Chronic Obstructive Lung Disease [GOLD] document), cystic fibrosis, bronchiectasis or alpha- 1 antitrypsin deficiency or any other significant lung disease which may interfere with study evaluations;
- Subjects who are current smokers; ex-smokers with total cumulative exposure ≥10 pack-years; having stopped smoking 1 year or less prior to the screening visit;
- Subjects who are treated with monoclonal antibodies (e.g., anti-immunoglobulin (Ig)E or anti-IgG antibodies) or biological drugs;
- Subjects who have received an investigational drug within 2 months or six half-lives (whichever is greater) prior to the screening visit, or have been previously randomised in this study, or are currently participating in another clinical study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Chaoyang District
Chen Wang, Academician, +86 -10 -84205288
- Recruiting
China-Japan Friendship Hospital
Beijing, Chaoyang District
Chen Wang, Academician
About this study
Official title: A 24 Week, Randomised, Double Blind, Multicentre, Active Controlled, 2-arm, Parallel Group Trial Comparing Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 100/6 μg HFA-134a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate) in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists
This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.
Read the detailed description
The study will be conducted at sites in China. The study will be composed of a run-in period with CHF 1535 pMDI HFA-134a (reference product) followed by a 24-week randomised treatment period when CHF 5993 pMDI HFA-152a (test product) or the reference product will be administered. Total study duration is 27 weeks. AEs and SAEs will be monitored from the informed consent signature until the subject's study participation ends, including AEs of particular interest such as cough. Serial spirometry will be performed both for subjects under study treatment as well as for subjects that discontinued the study treatments but continued the study using a different medication
- Conditions
- Asthma
- Being tested
- Experimental: Participant Group CHF 5993 pMDI HFA-152a, Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a
- Keywords
- Uncontrolled asthma, Triple therapy, HFA-152a, Pressurized metered-dose inhaler, China
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Participant Group CHF 5993 pMDI HFA-152aDrug
total daily dose of BDP/FF/GB:400/24/50 μg
Administration:
Two (2) inhalations twice daily(BID) (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF/GB: 400/24/50 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu AntiStaticTM to take the pMDI study treatments)
Active Comparator: CHF 1535 100/6 μg pMDI HFA-134aOther
total daily dose of BDP/FF: 400/24 μg
Administration:
Two (2) inhalations BID (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF: 400/24 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu Anti-StaticTM to take the pMDI study treatments).
| Study group | Role | What they receive |
|---|---|---|
| CHF 5993 pMDI HFA-152a | Experimental | Experimental: CHF 5993 pMDI HFA-152a; Fixed combination of beclometasone dipropionate (BDP) 100 μg+formoterol fumarate(FF) 6 μg+glycopyrronium bromide(GB) 12.5 μg, via pressurised metered dose inhaler(pMDI) with HFA-152a propellant. Receives: Drug: Experimental: Participant Group CHF 5993 pMDI HFA-152a |
| CHF 1535 pMDI HFA-134a | Active comparator | Comparator: CHF 1535 pMDI HFA-134a Fixed combination of BDP 100 μg+FF 6 μg, via pMDI with HFA-134a propellant. Receives: Other: Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak FEV1
FEV1 = forced expiratory volume in the first second
Measured: At week 24
Secondary outcomes (8)
Peak FEV1, FEV1, FEV1 area under curve(AUC)0-3h normalised by time
FEV1 = forced expiratory volume in the first second
Measured: up to 24 weeks
PEF
PEF = peak expiratory flow
Measured: at week 24
ACQ-7 score
The Asthma Control Questionnaire assesses asthma symptoms over last 7 days (night-time awakenings due to symptoms, morning symptoms, activity limitation, shortness of breath, wheezing), average daily rescue medication use, and current FEV1 percent predicted. Score scale: 0=totally controlled; 6=severely uncontrolled.
Measured: up to 24 weeks
Average use of rescue medication
Average use of rescue medication
Measured: at week 24
The number of moderate and severe exacerbations
The number of moderate and severe exacerbations
Measured: at week 24
Time to first moderate or severe exacerbation
Time to first moderate or severe exacerbation
Measured: at week 24
Average daily (morning and evening) asthma symptoms
Measured: at week 24
Percentage of asthma control days
Measured: at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start26 Jun 2026
- Primary completion17 Oct 2028 (estimated)
- Study completion17 Oct 2028 (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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Wang Academician, Principal Investigator, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546981
- Sponsor's protocol ID
- CLI-05993AA5-05
- Acronym
- TRICHECO
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2026
- Last updated
- 8 Jul 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Randomised, Double Blind, Multicentre, Active Controlled, 2-arm, Parallel Group Trial Comparing Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 100/6 μg HFA-134a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate) in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists
- ClinicalTrials.gov ID
- NCT07546981
- Acronym / sponsor ID
- TRICHECO / CLI-05993AA5-05
- Conditions
- Asthma
- Keywords
- Uncontrolled asthma, Triple therapy, HFA-152a, Pressurized metered-dose inhaler, China
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 17 Oct 2028 (estimated)
- Study completion
- 17 Oct 2028 (estimated)
- First posted
- 23 Apr 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.
This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.
Detailed description
The study will be conducted at sites in China. The study will be composed of a run-in period with CHF 1535 pMDI HFA-134a (reference product) followed by a 24-week randomised treatment period when CHF 5993 pMDI HFA-152a (test product) or the reference product will be administered. Total study duration is 27 weeks. AEs and SAEs will be monitored from the informed consent signature until the subject's study participation ends, including AEs of particular interest such as cough. Serial spirometry will be performed both for subjects under study treatment as well as for subjects that discontinued the study treatments but continued the study using a different medication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHF 5993 pMDI HFA-152a | Experimental | Drug: Experimental: Participant Group CHF 5993 pMDI HFA-152aExperimental: CHF 5993 pMDI HFA-152a; Fixed combination of beclometasone dipropionate (BDP) 100 μg+formoterol fumarate(FF) 6 μg+glycopyrronium bromide(GB) 12.5 μg, via pressurised metered dose inhaler(pMDI) with HFA-152a propellant. |
| CHF 1535 pMDI HFA-134a | Active comparator | Other: Active Comparator: CHF 1535 100/6 μg pMDI HFA-134aComparator: CHF 1535 pMDI HFA-134a Fixed combination of BDP 100 μg+FF 6 μg, via pMDI with HFA-134a propellant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
- ≤75 years;
Key exclusion criteria (10 listed)
- Subjects meeting any of the following criteria will be excluded from study enrolment:
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 |
|---|---|---|
| Experimental: Participant Group CHF 5993 pMDI HFA-152atotal daily dose of BDP/FF/GB:400/24/50 μg Administration: Two (2) inhalations twice daily(BID) (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF/GB: 400/24/50 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu AntiStaticTM to take the pMDI study treatments) | Drug | CHF 5993 pMDI HFA-152a |
| Active Comparator: CHF 1535 100/6 μg pMDI HFA-134atotal daily dose of BDP/FF: 400/24 μg Administration: Two (2) inhalations BID (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF: 400/24 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu Anti-StaticTM to take the pMDI study treatments). | Other | CHF 1535 pMDI HFA-134a |
Primary outcome
Peak FEV1
Time frame: At week 24
FEV1 = forced expiratory volume in the first second
8 secondary outcomes
Peak FEV1, FEV1, FEV1 area under curve(AUC)0-3h normalised by time
Time frame: up to 24 weeks
PEF
Time frame: at week 24
ACQ-7 score
Time frame: up to 24 weeks
Average use of rescue medication
Time frame: at week 24
The number of moderate and severe exacerbations
Time frame: at week 24
Time to first moderate or severe exacerbation
Time frame: at week 24
Average daily (morning and evening) asthma symptoms
Time frame: at week 24
Percentage of asthma control days
Time frame: at week 24
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 8 Jul 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.
Chen Wang Academician, Principal Investigator principal investigator
China-Japan Friendship Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: Participant Group CHF 5993 pMDI HFA-152a and Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 2 sites in China.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Clinical Trial INFO Chiesi Farmaceutici S.p.A. (+ 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?
Peak FEV1 (time frame: At week 24). 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 8 Jul 2026.