Trial · NCT05743075
A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT05743075, Phase 3, Completed, Nuance Pharma (shanghai) Co., Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. Trials, record NCT05743075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05743075
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- NCT number
- NCT05743075
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 526 participants, actual
- Lead sponsor
- Nuance Pharma (shanghai) Co., Ltd
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Ensifentrine, Placebo
- First posted
- 2023-02-24
- Last updated
- 2025-06-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h | 12 weeks | Change from baseline of Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h |
| Secondary | Peak FEV1 over 4 hours post-dose at Week 12 | 12 weeks | Change from baseline of Peak FEV1 over 4 hours post-dose at Week 12 |
| Secondary | Peak FEV1 at Week 6 and Week 24 | 6 or 24 weeks | Change from baseline peak FEV1 |
| Secondary | Morning trough FEV1 at Week 6 and Week 24 | 6 or 24 weeks | Change from baseline morning trough FEV1 |
| Secondary | Average FEV1 AUC0-4h at Week 6 and Week 24 | 6 or 24 weeks | Change from baseline average FEV1 AUC0-4h |
| Secondary | Average FEV1 AUC0-4h at Week 12 | 12 weeks | Change from baseline average FEV1 AUC0-4h |
| Secondary | Morning trough FEV1 at Week 12 | 12 weeks | Change from baseline of morning trough FEV1 at Week 12 |
| Secondary | Evening trough FEV1 at Week 12 | 12 weeks | Change from baseline of evening trough FEV1 at Week 12 |
| Secondary | Average FEV1 AUC6-12h at Week 12 | 12 weeks | Change from baseline of Average FEV1 AUC6-12h at Week 12 |
| Secondary | Rescue medication use at Weeks 6, 12 and 24 | 6, 12 or 24 weeks | Change from baseline of Rescue medication use |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41895581 | DERIVED |
Source PubMed
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/NCT05743075
GET https://conductscience.org/api/trials/v1/NCT05743075/registered