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A Study to Investigate Lung Deposition of Radiolabelled OligoG

NCT01991028 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-02-09

No results posted yet for this study

Summary

OligoG is a new potential treatment which is being developed by AlgiPharma AS (a Norwegian-based company) with an aim to help people with cystic fibrosis in the future.

OligoG, derived from marine algae, is expected to act locally in the lungs once inhaled to reduce mucus thickness and improve mucus clearance. It could also have the benefit of reducing the incidence of infections.

Nebulised doses of up to 540 mg/day have been administered to healthy volunteers for three consecutive days and to cystic fibrosis patients for 28 consecutive days. Both groups tolerated the medication well, with no treatment related issues reported. The dose administered in this study is lower; patients who complete the study will receive, in total, 186 mg of OligoG in two divided doses.

A new dry powder formulation of OligoG has been developed so that patients can use an inhaler, rather than a nebuliser. Administration from an inhaler compared to a nebuliser is much quicker and more practical for the patient.

In this study, we will use gamma scintigraphy to see where in the lungs the dry powder and nebulised solution go after being inhaled by cystic fibrosis patients. Gamma scintigraphy is a well-established medical imaging technique. A small amount of radioactive material will be added to both the dry powder and nebulised solution. The radiation emitted will then be detected by taking images using a device known as a gamma camera. The procedure is relatively easy and non-invasive.

The purpose of this study is to help answer the following research questions:

* How do the OligoG dry powder and nebulised solution distribute in the lungs of patients with cystic fibrosis?
* How much of the formulation gets to the deep lung?
* How much of the formulation remains in the devices used for administration?

Conditions

Interventions

DRUG

Radiolabelled OligoG CF-5/20 DPI

Inhalation with dry powder by Mia Monodose Inhaler

DRUG

Radiolabelled OligoG CF-5/20 6% Solution

Inhalation with aerosolised solution by nebuliser

Sponsors & Collaborators

  • AlgiPharma AS

    collaborator INDUSTRY

  • BDD Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Howard NE Stevens, PhD · BDD Pharma Ltd

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991028 on ClinicalTrials.gov