Trial · NCT07595796
An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment
NCT07595796, Not applicable, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment. Trials, record NCT07595796. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07595796
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment
- NCT number
- NCT07595796
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 23 participants, estimated
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Conditions
- Preserved Ratio Impaired Spirometry (PRISM)
- Interventions
- Budesonide/glycopyrronium bromide/formoterol inhalation aerosol
- First posted
- 2026-05-19
- Last updated
- 2026-05-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Trough forced expiratory volume in the first second (trough FEV1) | Baseline, Week 6, and Week 12 | Pulmonary function tests will be conducted using standardized spirometry (in accordance with ATS/ERS guidelines) at 12 hours post-dose (trough state). |
| Secondary | Saint George's Respiratory Questionnaire (SGRQ) Score | Baseline, Week 6, and Week 12 | The standardized SGRQ (Chinese version) will be self-administered by the subjects. |
| Secondary | COPD Assessment Test (CAT) Score | Baseline, Week 6, and Week 12 | The standardized CAT questionnaire (Chinese version) will be self-administered by the subjects. |
| Secondary | Adverse events (AEs) and serious adverse events (SAEs) | Baseline, Week 6, and Week 12 | All AE/SAE occurrences and types during the treatment period will be recorded. Grading will be performed according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Causality and severity will be assessed by the investigator. |
| Other | The association between biomarkers (such as peripheral blood eosinophil count and serum IgE level) and treatment efficacy | Baseline, Week 6, and Week 12 | 1. Stratify by baseline peripheral blood eosinophil (EOS) count: (i) EOS \<100/μL (ii) EOS ≥100 to \<300/μL (iii) EOS ≥300/μL Assess the improvement in trough FEV1 according to EOS count level. 2. Stratify by serum IgE level: (i) IgE \> upper limit of normal (ULN) (ii) IgE normal Assess the improvement in trough FEV1 according to IgE level. |
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/NCT07595796
GET https://conductscience.org/api/trials/v1/NCT07595796/registered