Trial · NCT04049175
Efficacy and Safety of CHF 6532 in Patients With Uncontrolled Severe Eosinophilic Asthma
NCT04049175, Phase 3, Terminated, Chiesi Farmaceutici S.p.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of CHF 6532 in Patients With Uncontrolled Severe Eosinophilic Asthma. Trials, record NCT04049175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04049175
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of CHF 6532 in Patients With Uncontrolled Severe Eosinophilic Asthma
- NCT number
- NCT04049175
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 810 participants, actual
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Conditions
- Asthma; Eosinophilic
- Interventions
- Treatment A, Treatment B, Treatment C, Treatment D
- First posted
- 2019-08-08
- Last updated
- 2022-04-08
- Other registries' IDs
- eudract:2018-003548-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of CHF 6532 on moderate and severe asthma exacerbations rate | Over 52 weeks of treatment | Rate of moderate and severe asthma exacerbations during the treatment period with CH 6532 (3 doses tested) or Placebo |
| Secondary | Effect of CHF 6532 on severe asthma exacerbations compared to Placebo | Over 52 weeks of treatment | Assessment of time to first moderate or severe exacerbation, and of time to first severe exacerbation |
| Secondary | Effect of CHF 6532 compared to Placebo in terms of change from baseline in pre-dose morning FEV1 (Forced Expiratory Volume in 1 second) | At Week 52 | Assessment of change from Baseline in pre-dose FEV1 |
| Secondary | Effect of CHF 6532 compared to Placebo in terms of change from baseline on St. George's Respiratory Questionnaire (SGRQ) | At Week 52 | Assessment of change from Baseline in SGRQ scores (Score range from 0 to 100, with lower scores corresponding to better health) |
| Secondary | Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Control Questionnaire (ACQ-5) | At Week 52 | Assessment of change from Baseline in ACQ-5 scores (Score range from 0=no impairment to 6= maximum impairment) |
| Secondary | Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Quality of Life Questionnaire (AQLQ+12) | At Week 52 | Assessment of change from Baseline in AQLQ+12 scores (Score range from 1=severe impairment to 7= no impairment) |
| Secondary | Pharmacokinetic analysis of CHF 6532 | At baseline and 3 months | Assessment of the area Under of the plasma concentration-time curve from 0 to the last quantifiable concentration (AUC0-t) of CHF 6532 |
| Secondary | Pharmacokinetic analysis of CHF 6532 | At baseline and 3 months | Assessment of the area Under of the plasma concentration versus time curve observed from time 0 up to 8 hours post-dose (AUC0-8h) of CHF 6532 |
| Secondary | Pharmacokinetic analysis of CHF 6532 | At baseline and 3 months | Assessment of the value of the maximum plasma concentration (Cmax) of CHF 6532 |
| Secondary | Pharmacokinetic analysis of CHF 6532 | At baseline and 3 months | Assessment of the time of the maximum plasma concentration (tmax) of CHF 6532 |
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT04049175
GET https://conductscience.org/api/trials/v1/NCT04049175/registered