NCT03698448

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

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AlgiPharma AS · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	OligoG Dry powder for inhalation	10 capsules Dry Powder for Inhalation, BID

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-10-01
• Completion: 2022-11-01
• First posted: 2018-10-09
• Last updated: 2022-06-30

Locations

1 site across 1 country: Germany