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Clinical trial

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

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Last updated:1st Dec 2019
Identifier: NCT03698448

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


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, double blind, dose-finding
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo medication with identical appearance to the active drug
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis
Estimated Study Start Date: December 1, 2019
Estimated Primary Completion Date: January 15, 2021
Estimated Study Completion Date: December 15, 2021

Arms:
- Placebo Comparator:
Placebo DPI
- Active Comparator: Low dose OligoG DPI
- Active Comparator: medium dose OligoG DPI
- Active Comparator: High dose OligoG DPI

Category Value
Date last updated at source 2019-10-10
Study type(s) Interventional
Expected enrolment 120
Study start date 2019-12-01
Estimated primary completion date 2021-01-15

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