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Trial · NCT04441788

Results by group45

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to PlaceboPlacebo0.0642Standard Deviation 0.2506liters
Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to PlaceboION-827359 37.5 mg-0.0240Standard Deviation 0.3581liters
Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to PlaceboION-827359 75 mg0.1336Standard Deviation 0.1087liters
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 PointPlacebo-1.08Standard Deviation 1.171score on a scale
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 PointION-827359 37.5 mg-1.41Standard Deviation 2.486score on a scale
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 PointION-827359 75 mg-1.99Standard Deviation 4.217score on a scale
Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time PointPlacebo-2.6Standard Deviation 2.51score on a scale
Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time PointION-827359 37.5 mg-0.6Standard Deviation 3.78score on a scale
Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time PointION-827359 75 mg0.0Standard Deviation 1.73score on a scale
Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time PointPlacebo-15.93Standard Deviation 19.515score on a scale
Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time PointION-827359 37.5 mg-1.74Standard Deviation 3.839score on a scale
Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time PointION-827359 75 mg-0.76Standard Deviation 2.350score on a scale
Change From Baseline in Post-Bronchodilator FEV1Placebo0.0663Standard Deviation 0.0685liters
Change From Baseline in Post-Bronchodilator FEV1ION-827359 37.5 mg0.0320Standard Deviation 0.2379liters
Change From Baseline in Post-Bronchodilator FEV1ION-827359 75 mg0.1180Standard Deviation 0.1006liters
Cmax: Maximum Observed Plasma Concentration for ION-827359ION-827359 37.5 mgDay 185.6Geometric Coefficient of Variation 198nanogram per milliliter (ng/mL)
Cmax: Maximum Observed Plasma Concentration for ION-827359ION-827359 75 mgDay 1203Geometric Coefficient of Variation 52.6nanogram per milliliter (ng/mL)
Cmax: Maximum Observed Plasma Concentration for ION-827359ION-827359 37.5 mgDay 8553.5Geometric Coefficient of Variation NAnanogram per milliliter (ng/mL)
Cmax: Maximum Observed Plasma Concentration for ION-827359ION-827359 75 mgDay 85195Geometric Coefficient of Variation 124nanogram per milliliter (ng/mL)
Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359ION-827359 37.5 mgDay 11.54Full Range 0.567 to 2.05hours

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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