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ongoing trials trial from www.clinicaltrials.gov

Clinical Trial to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Adults With CF - PHASE2 - RECRUITING

  • Year: 2024
  • Date: 04/06/2024
  • Author: Kors van der Ent
Source

https://ClinicalTrials.gov/show/NCT06468527

Study design (if review, criteria of inclusion for studies)

INTERVENTIONAL - Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

Participants

Cystic Fibrosis - ADULT, OLDER_ADULT

Interventions

DRUG: Diponecaftor|DRUG: Placebo

Outcome measures

Mean percent predicted forced expiratory volume in 1 second (ppFEV1), The primary endpoint in both groups is the mean percent predicted forced expiratory volume in 1 second (ppFEV1) of measurements taken after 4, 6 and 8 weeks of treatment. Period baseline values will be corrected for in the analysis., Measurements taken at 4, 6 and 8 weeks of treatment

Keywords: Dirocaftor; PTI-808; CFTR Modulators; pharmacological_intervention; Posenacaftor; PTI-801; Nesolicaftor; PTI-428;