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A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:
A Phase 2b Randomised, Double-blind, Parallel-group Study of Alginate Oligosaccharide (OligoG) Dry Powder Inhalation in Addition to Standard of Care Compared to Placebo in Addition to Standard of Care in Patients With Cystic Fibrosis (CF)

Clinical Trial Summary

A double-blind, randomised study of OligoG DPI compared to placebo DPI, both on top of standard-of-care, to assess safety, efficacy and tolerability. Adult patients with Cystic Fibrosis will be included in the study.

Clinical Trial Description

The alginate oligosaccharide OligoG CF-5/20 dry powder for inhalation (OligoG DPI) represents a novel therapeutic approach for patients with cystic fibrosis (CF). OligoG has been shown to release stagnant mucus, modulate sputum rheology and disrupt the biofilm formation often typically observed in CF. These properties will in turn facilitate mucus clearance and promote effectiveness of antibiotic therapy against the chronic pulmonary infections characteristic of CF.

Patients with CF (age 18 years or older) will be eligible to participate in this study.

The design will be a randomised, blinded, placebo-controlled pilot study for proof of concept that OligoG DPI can improve lung function in adult CF patients. Study medication will be given twice daily for twelve weeks on top of standard of care (SOC). Thirty-three patients will be included, out of which twenty-two shall receive OligoG, and eleven shall receive placebo.

After all patients have completed the 12 week double blind treatment period, all patients will be offered open-label OligoG twice daily, in addition to standard of care, for 12 months.

The primary endpoint will be absolute change i percent predicted FEV1

Exploratory parameters will include sputum microbiology. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03822455
Study type Interventional
Source AlgiPharma AS
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 16, 2019
Completion date July 10, 2021
View Details
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