Trial · NCT07546981
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
NCT07546981, Phase 3, Recruiting, Chiesi Farmaceutici S.p.A.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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. Trials, record NCT07546981. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07546981
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT07546981
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 554 participants, estimated
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Conditions
- Asthma
- Interventions
- Experimental: Participant Group CHF 5993 pMDI HFA-152a, Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a
- First posted
- 2026-04-23
- Last updated
- 2026-07-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak FEV1 | At week 24 | FEV1 = forced expiratory volume in the first second |
| Secondary | Peak FEV1, FEV1, FEV1 area under curve(AUC)0-3h normalised by time | up to 24 weeks | FEV1 = forced expiratory volume in the first second |
| Secondary | PEF | at week 24 | PEF = peak expiratory flow |
| Secondary | ACQ-7 score | up to 24 weeks | 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. |
| Secondary | Average use of rescue medication | at week 24 | Average use of rescue medication |
| Secondary | The number of moderate and severe exacerbations | at week 24 | The number of moderate and severe exacerbations |
| Secondary | Time to first moderate or severe exacerbation | at week 24 | Time to first moderate or severe exacerbation |
| Secondary | Average daily (morning and evening) asthma symptoms | at week 24 | |
| Secondary | Percentage of asthma control days | at week 24 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07546981
GET https://conductscience.org/api/trials/v1/NCT07546981/registered