Trial · NCT07388680
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase II and Phase III: The absolute value of the change in the predicted percentage of lung carbon monoxide diffusion capacity (DLCO% predicted) from the baseline at week 24. | At the 24th week of the experiment | DLCO% is a core indicator for evaluating pulmonary gas exchange function, reflecting the efficiency of oxygen transfer from the alveoli into the bloodstream. It is crucial for the diagnosis and prognosis of interstitial lung disease, pulmonary vascular disease, and similar conditions. DLCO% = measured diffusing capacity of the lung for carbon monoxide ÷ predicted value × 100%. Absolute value change refers to the direct difference between two consecutive measurements (for example, a decrease from 65% to 55% represents an absolute value change of -10%). |
| Secondary | Phase II and Phase III: The absolute values of the changes in DLCO% at weeks 2, 4, 8, and 16 compared to the baseline. | At weeks 2, 4, 8 and 16 of the trial | |
| Secondary | Phase II and III: Compared with the baseline, the changes in the measured values of pulmonary carbon monoxide diffusion capacity (DLCO) (in units of liters [L]) at weeks 2, 4, 8, 16, and 24. | At weeks 2, 4, 8,16 and 24 of the trial | |
| Secondary | Phase II and Phase III: Changes in forced vital capacity (FVC) (in liters) from baseline at weeks 2, 4, 8, 16, and 24. | At weeks 2, 4, 8,16 and 24 of the trial | |
| Secondary | Phase II and Phase III: The absolute value changes of forced vital capacity as a percentage of the predicted value (FVC%) from baseline at weeks 2, 4, 8, 16, and 24. | At weeks 2, 4, 8,16 and 24 of the trial | |
| Secondary | Phase II and Phase III: Changes in forced expiratory volume in one second (FEV1) (in liters) from baseline at weeks 2, 4, 8, 16, and 24. | At weeks 2, 4, 8,16 and 24 of the trial | |
| Secondary | Phase II and Phase III: The absolute value of the change in forced expiratory volume in one second as a percentage of the predicted value (FEV1%) from baseline at weeks 2, 4, 8, 16, and 24. | At weeks 2, 4, 8,16 and 24 of the trial | |
| Secondary | Phase II and Phase III: Changes in FEV1/FVC from baseline at weeks 2, 4, 8, 16, and 24. | At weeks 2, 4, 8,16 and 24 of the trial | |
| Secondary | Phase II and Phase III: Changes in the St. George's Respiratory Questionnaire (SGRQ) scores from baseline at weeks 4, 8, 16, and 24. | At weeks 4, 8,16 and 24 of the trial | The St. George's Respiratory Questionnaire (SGRQ) score is the standard instrument for assessing health-related quality of life in patients with chronic airway diseases. It comprises 76 items grouped into three domains-symptoms, activity, and disease impact. Each domain score and the overall total score are scaled from 0 to 100: 0 denotes "complete absence of symptoms or limitation," whereas 100 indicates "maximal severity." Higher scores signify a greater adverse effect of the disease on daily life. |
| Secondary | Phase II and Phase III: Changes in cough score from baseline at weeks 2, 4, 8, 16, and 24. | At weeks 2, 4, 8,16 and 24 of the trial | The cough score is a subjective instrument that quantifies the frequency, intensity, and disruptive impact of cough on daily activities and sleep into a 0-10-point or 0-100-mm scale; zero denotes complete absence of cough, and higher values indicate increasing symptom severity. |
| Secondary | Phase II and Phase III: Changes in the Modified Medical Research Council Dyspnea Scale (mMRC) score at weeks 2, 4, 8, 16, and 24 compared to the baseline. | At weeks 2, 4, 8,16 and 24 of the trial | The Modified Medical Research Council Dyspnea Scale (mMRC) is a five-level instrument that rapidly quantifies the extent to which breathlessness limits physical activity; higher grades indicate greater disability. |
| Secondary | Phase II and Phase III: Compared with the baseline, the changes in computed tomography (CT) imaging scores at weeks 4, 8, 16, and 24 | At weeks 4, 8,16 and 24 of the trial | CT imaging score is a standardized method that converts anatomical or functional features observed on CT scans into quantifiable numerical values, used for disease diagnosis, staging, treatment response monitoring, or prognostic assessment.Referring to the HRCT scoring system, the scores were assigned by imaging experts after consensus , with higher values generally indicating more severe disease. |
| Secondary | Phase II and Phase III: The proportion of subjects with CIP at baseline who discontinued immunotherapy and experienced immune reactivation during the study period. | Within 24 weeks | |
| Secondary | Phase II and Phase III: The proportion of subjects whose lung injury grade decreased by at least one level compared to the baseline at week 24. | Within 24 weeks | According to the Common Terminology Criteria for Adverse Events, Version 5.0, pulmonary injury is graded, with higher grades indicating more severe symptoms. |
| Secondary | Phase II and Phase III: The proportion of subjects achieving a lung injury level of ≤ 1 at the 24th week compared to the baseline. | Within 24 weeks | According to the Common Terminology Criteria for Adverse Events, Version 5.0, pulmonary injury is graded, with higher grades indicating more severe symptoms. |
| Secondary | Phase II and Phase III: The time required for the subjects to first achieve a lung injury level of ≤ 1. | Within 24 weeks | According to the Common Terminology Criteria for Adverse Events, Version 5.0, pulmonary injury is graded, with higher grades indicating more severe symptoms. |
| Secondary | Phase II and Phase III: The proportion of subjects who experienced their first acute pulmonary deterioration or died for any reason within 24 weeks of treatment. | Within 24 weeks | Acute pulmonary deterioration is defined as the unexplained worsening or new onset of cough, dyspnea, hypoxia, or pneumonia from the completion of initial treatment up to Week 24, persisting for \>4 days, with chest CT showing new or increased diffuse pulmonary infiltrates in the absence of pneumothorax or pleural effusion, and after exclusion of pneumonia, congestive heart failure, pulmonary embolism, or cancer progression. Pulmonary deterioration occurring within the first 2 weeks after initial treatment is not counted toward the endpoint, allowing full resolution of initial symptoms. |
| Secondary | Phase II and Phase III: Analyze the blood drug concentration of pirfenidone capsules, evaluate the steady-state blood drug trough concentration for individual patients and each group of people at specific treatment time poin | on days 1, 14, 28, 56, 112, and 168 of the trial | |
| Secondary | Phase II and Phase III: Analyze the blood drug concentration of pirfenidone capsules, evaluate the PopPK characteristics for individual patients and each group of people at specific treatment time poin | on days 1, 14, 28, 56, 112, and 168 of the trial | |
| Secondary | Phase II and Phase III: Adverse events/serious adverse events (AE/SAE). | Within 24 weeks | Adverse Event (AE) refers to any untoward and unintended medical occurrence experienced by a trial participant during treatment or clinical investigation, regardless of causal relationship to the investigational product. Serious Adverse Event (SAE) is a subset of AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, causes persistent or significant disability/incapacity, leads to congenital anomaly/birth defect, or is judged medically important by the investigator. According to the Common Terminology Criteria for Adverse Events, Version 5.0, pulmonary injury is graded, with higher grades indicating more severe symptoms. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07388680/registered