Trial · NCT07016412
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Forced Expiry Volume in 1 Second (FEV1) Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h) | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 4 hours on Day 28 will be reported. |
| Secondary | Change From Baseline in Peak FEV1 Measured Over 4 Hours Post-Dose | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in peak FEV1 over 4 hours following dosing on Day 28 will be reported. |
| Secondary | Change From Baseline in Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h) | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 12 hours on Day 28 will be reported. |
| Secondary | Change From Baseline in Morning Trough FEV1 on Day 29 | Baseline and Day 29 | Spirometry will be performed to determine the FEV1. Change from baseline in morning trough FEV1 measured on Day 29 will be reported. |
| Secondary | Change From Baseline in Evening Trough FEV1 on Day 28 | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in evening trough FEV1 measured on Day 28 will be reported. |
| Secondary | Change From Baseline in Morning Trough FEV1 on Day 28 | Baseline and Day 28 | Spirometry will be performed to determine the FEV1. Change from baseline in morning trough FEV1 measured on Day 28 will be reported. |
| Secondary | Change From Baseline in Average FEV1 AUC0-4h Measured After First Dose on Day 14 | Baseline and Day 14 | Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 4 hours following the first dose on Day 14 will be reported. |
| Secondary | Change From Baseline in Peak FEV1 Measured Over 4 Hours After First Dose on Day 14 | Baseline and Day 14 | Spirometry will be performed to determine the FEV1. Change from baseline in peak FEV1 over 4 hours following the first dose on Day 14 will be reported. |
| Secondary | Change From Baseline in Average FEV1 AUC0-4h Measured After First Dose on Day 1 | Baseline and Day 1 | Spirometry will be performed to determine the FEV1. Change from baseline in average FEV1 area under the curve from 0 to 4 hours following the first dose on Day 1 will be reported. |
| Secondary | Change from Baseline in Peak FEV1 Measured Over 4 Hours After First Dose on Day 1 | Baseline and Day 1 | Spirometry will be performed to determine the FEV1. Change from baseline in peak FEV1 over 4 hours following the first dose on Day 1 will be reported. |
| Secondary | Change in Symptoms of Dyspnea from Baseline as Measured by Transition Dyspnea Index (TDI) Score on Day 14 | Baseline and Day 14 | The TDI measures the change in dyspnea symptom severity from the baseline as measured by the Baseline Dyspnea Index (BDI). It is based on three components, functional impairment, magnitude of task, and magnitude of effort, that evoke dyspnea in activities of daily living. The BDI score ranges from 0 (very severe impairment) to 4 (no impairment) for each domain and are summed to determine the BDI focal score (0-12). The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score (-9 to +9). Change from baseline in TDI score on Day 14 will be reported. |
| Secondary | Change in Symptoms of Dyspnea from Baseline as Measured by TDI Score on Day 28 | Baseline and Day 28 | The TDI measures the change in dyspnea symptom severity from the baseline as measured by the BDI. It is based on three components, functional impairment, magnitude of task, and magnitude of effort, that evoke dyspnea in activities of daily living. The BDI score ranges from 0 (very severe impairment) to 4 (no impairment) for each domain and are summed to determine the BDI focal score (0-12). The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score (-9 to +9). Change from baseline in TDI score on Day 28 will be reported. |
| Secondary | Change From Baseline in Health-Related Quality of Life as Measured by Saint George's Respiratory Questionnaire (SGRQ) Total Score | Baseline and Day 28 | The SGRQ Patient Reported Outcome (PRO) measure is a 50- item questionnaire designed to assess health-related quality of life in patients with COPD in terms of symptoms, daily activity limitation, and psychosocial well-being. The total score ranges from 0 to 100, with lower scores indicating better health status. Change from baseline in health-related quality of life as assessed using SGRQ total score on Day 28 will be reported. |
| Secondary | Number of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) | Up to approximately 5 weeks | An AE is any untoward medical occurrence in a subject, temporally associated with the use of the study medication, whether or not considered related to the study medication. Number of participants who experience at least one TEAE will be reported. |
| Secondary | Number of Participants With Markedly Abnormal Changes in Hematology Parameters | Up to approximately Day 28 | Number of participants with markedly abnormal changes in hematology parameters will be reported. |
| Secondary | Number of Participants With Markedly Abnormal Changes in Blood Chemistry Parameters | Up to approximately Day 28 | Number of participants with markedly abnormal changes in blood chemistry parameters will be reported. |
| Secondary | Number of Participants With Markedly Abnormal Changes in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) | Up to approximately Day 28 | Number of participants with markedly abnormal changes in QTcF measurements will be reported. |
| Secondary | Number of Participants With Markedly Abnormal Changes in Heart Rate | Up to approximately Day 28 | Number of participants with markedly abnormal changes in heart rate will be reported. |
| Secondary | Number of Participants With Markedly Abnormal Changes in Blood Pressure | Up to approximately Day 28 | Number of participants with markedly abnormal changes in blood pressure will be reported. |
| Secondary | Number of Participants With Markedly Abnormal Changes in Pulse Rate | Up to approximately Day 28 | Number of participants with markedly abnormal changes in pulse rate will be reported. |
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.
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