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Trial · NCT06460493

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYThe Proportion of CAT Score Responders in the Full Analysis Set at Week 1212 WeeksThe full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYThe Proportion of CAT Score Responders in the Full Analysis Set at Week 66 WeeksThe full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMean Change From Baseline - CAT Score in the Full Analysis SetAt week 6 and week 12The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.units on a scaleLEAST_SQUARES_MEAN
SECONDARYMean Change From Baseline - CAT Individual Item (1, Cough) in the Full Analysis SetAt week 6 and week 12The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.units on a scaleLEAST_SQUARES_MEAN
SECONDARYMean Change From Baseline - CAT Individual Item (2, Mucus) in the Full Analysis SetAt week 6 and week 12The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.units on a scaleLEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIEDMean Change From Baseline in Blood Pressure in the Safety Analysis Set12 Weeks
The safety analysis set (SAS) included all subjects who were administered the study medication at day 1 (n=20). However, 2 subjects did not complete week 6 and week 12 visits and did not have a change from baseline calculated.
mmHgMEAN
OTHER_PRE_SPECIFIEDMean Change From Baseline in Pulse Rate in the Safety Analysis Set12 Weeks
The safety analysis set (SAS) included all subjects who were administered the study medication at day 1 (n=20). However, 2 subjects did not complete week 6 and week 12 visits and did not have a change from baseline calculated.
bpmMEAN
SECONDARYMean Change From Baseline - CAT Individual Item (3, Chest Tight) in the Full Analysis SetAt week 6 and week 12The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.units on a scaleLEAST_SQUARES_MEAN
SECONDARYMean Change From Baseline - CAT Individual Item (4, Breathless) in the Full Analysis SetAt week 6 and week 12The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.units on a scaleLEAST_SQUARES_MEAN
SECONDARYMean Change From Baseline - CAT Individual Item (5, Activities) in the Full Analysis SetAt week 6 and week 12The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.units on a scaleLEAST_SQUARES_MEAN
SECONDARYMean Change From Baseline - CAT Individual Item (6, Confidence) in the Full Analysis SetAt week 6 and week 12The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.units on a scaleLEAST_SQUARES_MEAN
SECONDARYMean Change From Baseline - CAT Individual Item (7, Sleep) in the Full Analysis SetAt week 6 and week 12The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.units on a scaleLEAST_SQUARES_MEAN
SECONDARYMean Change From Baseline - CAT Individual Item (8, Energy) in the Full Analysis SetAt week 6 and week 12The full analysis set (FAS) included all subjects administered the study medication at visit 2 (day 1), and had a CAT completed at baseline and from at least one post-treatment visit.units on a scaleLEAST_SQUARES_MEAN

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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