Trial · NCT04441788
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo | From Baseline up to average of Weeks 13 and 14 | FAS=all randomized participants who had ≥1 dose of study drug(ION 827359/placebo),≥1 post-Baseline efficacy assessment(i.e.,post-Baseline FEV1,Exacerbations of Chronic pulmonary Disease Tool\[EXACT\]Respiratory Symptoms\[E-RS\]score,Chronic Obstructive Pulmonary Disease\[COPD\]Assessment Test\[CAT\]score,or St.George's Respiratory Questionnaire-COPD Specific\[SGRQ-C score\],post-bronchodilator FEV1).Overall number analyzed:number of participants with data available for analyses in this outcome measure. | liters | MEAN |
| SECONDARY | Change From Baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Respiratory Symptoms (E-RS) Daily Symptom Diary Total Score to the Primary Time Point | From Baseline up to average of weeks 13 and 14 | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time Point | From Baseline to Week 14 | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time Point | From Baseline to Week 14 | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Post-Bronchodilator FEV1 | From Baseline to end of treatment (EOT) [Up to Week 14] | FAS included all randomized participants who received at least 1 dose of study drug (ION-827359 or placebo) and who had at least 1 post-Baseline efficacy assessment (i.e., post-Baseline FEV1 assessment, E-RS score, CAT score, or SGRQ-C score). Overall number of participants analyzed is the number of participants with data available for analyses in this outcome measure. | liters | MEAN |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration for ION-827359 | Days 1 and 85 | Pharmacokinetic (PK) population included all participants who were randomized and received at least 1 dose of active study drug (ION-827359) and had at least 1 evaluable PK sample collected and analyzed with reportable result. Number analyzed is the number of participants with data available for analysis at the specified time point. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359 | Days 1 and 85 | PK population included all participants who were randomized and received at least 1 dose of active study drug (ION-827359) and had at least 1 evaluable PK sample collected and analyzed with reportable result. Number analyzed is the number of participants with data available for analysis at the specified time point. | hours | MEDIAN |
| SECONDARY | AUC[0-24h]: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours for ION-827359 | Days 1 and 85 | PK population consisted of all the participants who were randomized and received at least 1 dose of active study drug (ION-827359) and had at least 1 evaluable PK sample collected and analyzed with reportable result. Number analyzed is the number of participants with data available for analysis at the specified time point. | hours*nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) Based on Severity | Up to Week 24 | Safety population included all participants who were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Significant Change in Laboratory Values | Up to Week 24 | Safety population included all participants who are were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Significant Change in Vital Sign Parameters | Up to Week 24 | Safety population included all participants who are were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings | Up to Week 24 | Safety population included all participants who were randomized and received at least 1 dose of study drug. | percentage of participants | NUMBER |
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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GET https://conductscience.org/api/trials/v1/NCT04441788/outcomes