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A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis — SMR3372  

Cystic Fibrosis Clinical Trial

Official title:
A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis

Clinical Trial Summary

Randomized, double blind, placebo controlled study. The study has two parts: Dose-finding part, followed by longer term follow-up (6 months)

Clinical Trial Description

Part 1: Randomized, double blind, placebo controlled dose-finding. Patients will be assigned to 1 of 3 doses OligoG, or to placebo, on top of Standard of Care. Patients will be treated for 12 weeks, followed by 4 weeks washout.The primary endpoint is relative change in % predicted FEV1. Secondary endpoints include additional spirometry parameters, exacerbation rate, Quality of Life, sputum rheology and microbiology, safety laboratory tests and adverse event reporting. Part 2: Randomized double-blind 6 -month study, for longer term follow-up of the dose identified in Part 1. New patients will be recruited in part 2, in addition to patients who received placebo in Part 1. In addition to the endpoints studied in Part 1, Part 2 will include Lung Clearance Index (LCI), chest imaging by MRI or CT, and pharmaco-economic parameters. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03698448
Study type Interventional
Source AlgiPharma AS
Contact
Status Withdrawn
Phase Phase 2/Phase 3
Start date September 1, 2021
Completion date November 1, 2022
View Details
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