A Study to Investigate Lung Deposition of Radiolabelled OligoG

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01991028
• Date of registration: 18/11/2013
• Prospective Registration: Yes
• Primary sponsor: Bio-Images Research Ltd
• Public title: A Study to Investigate Lung Deposition of Radiolabelled OligoG
• 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
• Date of first enrolment: April 2014
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01991028
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Howard NE Stevens, PhD
• Affiliation: Bio-Images Research Ltd

Key inclusion & exclusion criteria

Inclusion Criteria:

Aged at least 18 years at screening. Understands and is willing, able and likely to comply
with all study procedures and restrictions.

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.

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

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 enrolled with positive
findings is at least 80%.

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)

Clinically stable in the opinion of the referring physician at CF unit.

Female subjects of child-bearing potential and male subjects participating in the study
who are sexually active must use acceptable contraception. 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

Exclusion Criteria:

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.

History of, or planned organ transplantation.

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

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

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.

Unable to perform pulmonary function tests according to ATS criteria.

Pregnant or breast-feeding women.

Participated in any interventional clinical trial within the 28 days prior to AV1.

Documented or suspected, clinically significant, alcohol or drug abuse.

Known allergies or intolerances to alginates.

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

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.

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

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.

Males who intend to father a child in 3 months following study or are unwilling to abstain
from sexual intercourse with pregnant or lactating women. Females who are intending to
become pregnant in 3 months following study.

Any non-removable metal objects such as metal plates, screws etc in their head, neck,
chest or abdominal area.

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Radiolabelled OligoG CF-5/20 DPI

Drug: Radiolabelled OligoG CF-5/20 6% Solution

Primary Outcome(s)

To qualitatively determine the deposition of radiolabelled OligoG in the lung. [Time Frame: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)]

Secondary Outcome(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) [Time Frame: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)]

To characterise the extrapulmonary 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) [Time Frame: 1 day (Scintigraphic imaging will be performed at one time point only; immediately after dosing)]

Secondary ID(s)

BC-180-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AlgiPharma AS