Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:06 PM
Study NCT ID:
NCT01991028
Status:
COMPLETED
Last Update Posted:
2015-02-09
First Post:
2013-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Lung Deposition of Radiolabelled OligoG
Sponsor:
BDD Pharma Ltd
Organization:
Study Overview
Official Title:
An Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis Patients
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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?
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?
Detailed Description:
The primary efficacy (deposition) variable will be the % dose deposited in the lungs.
The following secondary efficacy (deposition) variables will be determined (where appropriate): Percentage dose deposited in the oropharyngeal, oesophageal and gastric regions Percentage dose remaining in the Miat Monodose inhaler Percentage dose remaining in the nebuliser mouthpiece Percentage dose remaining in the nebuliser reservoir Percentage dose deposited on the exhalation filter (if appropriate) Percentage dose contained in mouth washing(s) Penetration index based on the ratio of counts in the central:peripheral lung regions (C/P index)
The following secondary efficacy (deposition) variables will be determined (where appropriate): Percentage dose deposited in the oropharyngeal, oesophageal and gastric regions Percentage dose remaining in the Miat Monodose inhaler Percentage dose remaining in the nebuliser mouthpiece Percentage dose remaining in the nebuliser reservoir Percentage dose deposited on the exhalation filter (if appropriate) Percentage dose contained in mouth washing(s) Penetration index based on the ratio of counts in the central:peripheral lung regions (C/P index)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: