Trial · NCT06029595
Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
NCT06029595, Phase 2, Terminated, Chiesi Farmaceutici S.p.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy. Trials, record NCT06029595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06029595
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
- NCT number
- NCT06029595
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 517 participants, actual
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Conditions
- Uncontrolled Asthma
- Interventions
- Experimental: CHF6001 3200 μg, Placebo Comparator: CHF6001 Placebo
- First posted
- 2023-09-08
- Last updated
- 2025-12-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Asthma exacerbation over 52 weeks of treatment | Over 52 weeks | Number of Asthma exacerbation over 52 weeks of treatment (Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization) |
| Secondary | Time to first asthma exacerbation; | Up to 52 weeks | Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization |
| Secondary | Number of asthma exacerbation and asthma worsening over 52 weeks of treatment | Up to 52 weeks | Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation. |
| Secondary | Time to first asthma exacerbation or asthma worsening | Up to 52 weeks | Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation. |
| Secondary | ACQ-7 responders | week 4, week 26 and week 52 | ACQ-7 responders at Week 4, Week 26 and Week 52 (i.e., subjects showing improvement from baseline in ACQ-7 score of ≥0.5 units); |
| Secondary | Change from baseline in ACQ-7 and ACQ-6 | week 4, week 26 and week 52 | Change from baseline in ACQ-7 and ACQ-6 at Week 4, Week 26 and Week 52 |
| Secondary | Change from baseline in Mini-AQLQ | week 4, week 26 and week 52 | Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52 |
| Secondary | Change from baseline in pre-dose FEV1 | week 4, week 26 and week 52 | Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52; |
| Secondary | Change from baseline in pre-dose FVC | Week4, Week 52 and Week 26 | Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26; |
| Secondary | Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF; | Up to 52 weeks |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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/NCT06029595
GET https://conductscience.org/api/trials/v1/NCT06029595/registered