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Trial · NCT05270525

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe Absolute Change From Baseline in Sputum Neutrophil Cell NumbersBaseline and 8 WeeksThe Absolute change from baseline in sputum neutrophil cell numbers will be reported.
SecondaryAbsolute Change in Cell Numbers From Baseline in Sputum Cell CountsBaseline and 8 WeeksAbsolute change in cell numbers from baseline in sputum cell counts (eosinophils, basophils, macrophages, lymphocytes, total cells) will be reported.
SecondaryPercent Change From Baseline in Sputum Cell CountsBaseline and 8 WeeksPercent change from baseline in sputum cell counts (neutrophils, eosinophils, basophils, macrophages, lymphocytes, and total cells) will be reported.
SecondaryPercent Change From Baseline in CytokinesBaseline and 8 WeeksPercent Change From Baseline in Cytokines will be reported.
SecondaryPercent Change From Baseline in ProteasesBaseline and 8 WeeksPercent Change From Baseline in Proteases will be reported.
SecondaryPercent Change From Baseline in Markers of InflammationBaseline and 8 WeeksPercent Change From Baseline in Markers of Inflammation will be reported.
SecondaryChange From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 4 WeeksBaseline and 4 WeeksChange from baseline in FEV1 at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
SecondaryChange From Baseline in FEV1 at 8 WeeksBaseline and 8 WeeksChange from baseline in FEV1 at 8 weeks during the treatment period (postdose) will be reported.
SecondaryChange From Baseline in Forced Vital Capacity (FVC) at 4 WeeksBaseline and 4 WeeksChange from baseline in FVC at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
SecondaryChange From Baseline in FVC at 8 WeeksBaseline and 8 WeeksChange from baseline in FVC at 8 weeks during the treatment period (postdose) will be reported.
SecondaryChange From Baseline in Residual Volume (RV) at 4 WeeksBaseline and 4 WeeksChange from baseline in RV at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
SecondaryChange From Baseline in RV at 8 WeeksBaseline and 8 WeeksChange from baseline in RV at 8 weeks (postdose) during the treatment period will be reported.
SecondaryChange From Baseline in Functional Residual Capacity (FRC) at 4 WeeksBaseline and 4 WeeksChange from baseline in FRC at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
SecondaryChange From Baseline in FRC at 8 WeeksBaseline and 8 WeeksChange from baseline in FRC at 8 weeks (postdose) during the treatment period will be reported.
SecondaryChange From Baseline in Total Lung Capacity (TLC) at 4 WeeksBaseline and 4 WeeksChange from baseline in TLC at 4 weeks during the treatment period (predose and 2 hours postdose) will be reported.
SecondaryChange From Baseline in TLC at 8 WeeksBaseline and 8 WeeksChange from baseline in TLC at 8 weeks (postdose) during the treatment period will be reported.
SecondaryNumber of Participants Who Experience One or More Adverse Events (AEs)Up to approximately 8 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Number of participants who experience one or more adverse events will be reported.
SecondaryChange From Baseline in Systolic Blood PressureBaseline and 8 WeeksChange from baseline in systolic blood pressure will be reported.
SecondaryChange From Baseline in Diastolic Blood PressureBaseline and 8 WeeksChange from baseline in diastolic blood pressure will be reported.
SecondaryChange From Baseline in Heart RateBaseline and 8 WeeksChange from baseline in heart 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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