CFDB - Cystic Fibrosis DataBase

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ongoing trials trial from other registries

Tolerability and Safety of Inhaled Colistimethate Sodium (CMS) Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT) - Not yet recruiting

  • Year: 2024
  • Date: new
  • Author:
Source

https://anzctr.org.au/ACTRN12624000601538.aspx

Participants

3 patients 0-17 years with Cystic Fibrosis

Interventions

VX-445/VX-661/VX-770 fixed-dose combination granules, VX-445/VX-661/VX-770 fixed-dose combination granules, VX-770 granules, Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets, Kalydeco 150 mg film-coated tablets, VX-770 75mg, Kaftrio 75 mg/50 mg/100 mg film-coated tablets, Kalydeco 75 mg film-coated tablets, Kalydeco 75 mg granules in sachet

Outcome measures

Safety and tolerability of ELX/TEZ/IVA based on adverse events (AEs), clinical laboratory values, standard 12-lead ECGs, vital signs, and pulse oximetry

Keywords: CFTR Modulators; Genetic Predisposition to Disease; pharmacological_intervention; placebo; VX-770; VX-661; ivacaftor; Aminophenols; tezacaftor; VX-445; elexacaftor; Trikafta; kaftrio;