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Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults — APPLAUD  

Cystic Fibrosis Clinical Trial

Official title:
APPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in Adults

Clinical Trial Summary

An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.

Clinical Trial Description

An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF. All patients will remain on their CF standard-of-care treatments over the trial duration. The goal for the treatment with LAU-7b in CF is to preserve lung function by reducing the persistent inflammation in the lung and to improve its capacity to defend against resistant bacteria such as Pseudomonas aeruginosa. The treatment regimen will consist of 6 consecutive "dosing cycles" of 21 days each, spaced by study drug-free periods of 7 days. A total of 136 eligible adult patients with CF will be randomized to receive 300 mg LAU-7b or placebo in a 1:1 ratio. The participation in the study will last about 7 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03265288
Study type Interventional
Source Laurent Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 2
Start date October 10, 2018
Completion date September 15, 2021
View Details
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