A study to investigate lung deposition of radiolabelled OligoG(v1.0)

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2013-003774-27-GB
• Date of registration: 27/11/2013
• Prospective Registration: Yes
• Primary sponsor: AlgiPharma AS
• Public title: A study to investigate lung deposition of radiolabelled OligoG(v1.0)
• Scientific 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 - A study to investigate lung deposition of radiolabelled OligoG (v1.0)
• Date of first enrolment: 20/01/2014
• Target sample size: 12
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003774-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Contacts

• Name: Lee Ann Hodges
• Affiliation: Bio-Images Research Ltd

• Name: Lee Ann Hodges
• Affiliation: Bio-Images Research Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged at least 18 years at screening.

2. Understands and is willing, able and likely to comply with all study procedures and restrictions.

3. Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)

4. Male or female with a confirmed diagnosis of cystic fibrosis defined by:
i. Clinical features consistent with the diagnosis of cystic fibrosis (Rosenstein et al., 1998); AND
ii. Sweat chloride = 60 mmol/L by pilocarpine iontophoresis; OR
iii. Genotypic confirmation of 2 CF-causing mutations

5. Positive microbiological finding of Pseudomonas aeruginosa (mucoid or nonmucoid) in expectorated sputum (and/or swab) documented within the last 24 months prior to screening. Negative finding is acceptable provided the proportion of patients with positive findings is at least 80% as possible.

6. At screening, FEV1 must be between 35 and 80% of the predicted normal value following adjustment for age, gender and height according to the Knudson equation (Knudson et al., 1983)

7. Be clinically stable in the opinion of the referring physician at the CF unit.

8. Female subjects of child-bearing potential and male subjects participating in the study who are sexually active must use acceptable contraception. Female subjects documented as being of non-child bearing potential are exempt from the contraceptive requirements. For the purpose of this study, acceptable contraception is defined as:
i. Oral, injected or implanted hormonal methods or contraception; OR
ii. Placement of an intrauterine device (IUD) or intrauterine system (IUS); OR
iii. Barrier methods of contraception: condom or occlusive cap with spermicidal foam/gel/film/cream/suppository

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
1. On-going acute illness. Patients must not have needed an outpatient visit, hospitalisation or required any change in therapy for other pulmonary disease between screening and AV1.

2. History of, or planned organ transplantation.

3. Requirement for continuous (24 hour/day) oxygen supplementation.

4. Concomitant administration of inhaled mannitol or hypertonic saline within 48 hours of Period 1, Day 1.

5. Clinically significant abnormal findings on haematology or clinical chemistry. In addition, any value = 3 x the upper limit of normal will exclude the patient from participating in the study.

6. Patients unable to perform pulmonary function tests according to ATS criteria.

7. Pregnant or breast-feeding women. A negative pregnancy test must be demonstrated in females of child-bearing potential at screening.

8. Patients who have participated in any interventional clinical trial within the 28 days prior to AV1.

9. Patients with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be made by the study physician.

10. Known allergies or intolerances to alginates.

11. Any active malignant disease (with the exception of basal cell carcinoma; BCC).

12. Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol.

13. Haemoptysis more than 60 mL at any time within 30 days before study drug administration.

14. Patients for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 mSv), or will exceed 10 mSv over any three year period.

15. Male patients who are intending to father a child in the 3 months following the study or are unwilling to abstain from sexual intercourse with pregnant or lactating women. Female patients who are intending to become pregnant in the 3 months following the study.

16. Patients who have any non-removable metal objects such as metal plates, screws etc in their head, neck, chest or abdominal area.

17. As a result of a physical examination or screening investigations, the physician responsible considers the patient unfit for the study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Name: Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI)
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: OligoG
CAS Number: 9005-38-3
Current Sponsor code: OligoG CF-5/20
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 96-

Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: OligoG
CAS Number: 9005-38-3
Current Sponsor code: OligoG CF-5/20
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Scintigraphic imaging will be performed at one timepoint only: immediately after dosing.

Secondary Objective: To determine the radiolabel distribution pattern of the two formulations in the diseased lung, including calculating the ratio of radiolabel in the central airways compared to the peripheral region (C/P index)

To characterise the extra-pulmonary deposition (i.e. oropharyngeal and stomach) of radiolabel including retention in the nebuliser or dry powder inhaler reservoir and deposition on the exhalation filter (if appropriate).

Main Objective: To determine the lung deposition of OligoG when administered to cystic fibrosis patients either as a nebulised solution or as a dry powder for inhalation.

Primary end point(s): To qualitatively determine the deposition of radiolabelled OligoG in the lung.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Scintigraphic imaging will be performed at one timepoint only: immediately after dosing.

Secondary end point(s): To determine the radiolabel distribution pattern of the two formulations in the diseased lung, including calculating the ratio of radiolabel in the central airways compared to the peripheral region (C/P index).

To characterise the extra-pulmonary deposition (i.e. oropharyngeal and stomach) of radiolabel including retention in the nebuliser or dry powder inhaler reservoir and deposition on the exhalation filter (if appropriate).

Secondary ID(s)

BC-180-12

Source(s) of Monetary Support

Technology Strategy Board