SNPMiner Trials by Shray Alag

SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT02157922

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis

The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis.

NCT02157922 Cystic Fibrosis
MeSH: Fibrosis Cystic Fibrosis

1 Interventions

Name: alginate oligosaccharide

Description: Inhalation

Type: Drug

Alginate oligosaccharide Placebo

Primary Outcomes

Description: An improvement in FEV1 during treatment with OligoG as compared to placebo is the primary endpoint of the study.

Measure: FEV1 (Forced Expiratory Volume in 1 second)

Time: 28 days, i.e. start and end of treatment periods

Secondary Outcomes

Description: Mucociliary clearance is assessed by measuring the movement of an inhaled radiotracer up the airways.

Measure: Mucociliary and cough clearance

Time: 28 days, i.e. start and end of treatment periods

Other Outcomes

Description: Measurement of vital signs, ECG, blood oxygen saturation and pulmonary function tests. Adverse events and concomitant medications will be recorded, and blood samples will be collected for hematology, clinical chemistry and OligoG concentration.

Measure: Safety

Time: Screening, day 0, 14, 28, 56, 70, 84 and follow up

Purpose: Treatment

Allocation: Randomized

Crossover Assignment

There is one SNP


1 G551D

- Diagnosed with the G551D-mutation, and currently on concomitant treatment with Ivacaftor (Kalydeco). --- G551D ---

HPO Nodes