A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03822455
• Date of registration: 29/01/2019
• Prospective Registration: Yes
• Primary sponsor: AlgiPharma AS
• Public title: A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis
• Scientific title: A Phase 2b Randomised, Double-blind, Parallel-group Study of Alginate Oligosaccharide (OligoG) Dry Powder Inhalation in Addition to Standard of Care Compared to Placebo in Addition to Standard of Care in Patients With Cystic Fibrosis (CF)
• Date of first enrolment: May 16, 2019
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03822455
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Peter Wark
• Affiliation: John Hunter Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Genotypic confirmation of CFTR mutation or clinical diagnosis of Cystic Fibrosis (CF)
confirmed by a sweat chloride value =60 mmol/L by quantitative pilocarpine
iontophoresis.

- Age 18 years or older.

- Male or female patients with any ethnicity.

- FEV1 at screening in the range of =40% and 90% of the predicted normal for age, sex,
and height, according to the GLI equation (Eur Respir J. Dec 2012; 40(6): 1324-1343).

- History of Pseudomonas aeruginosa (PA) infection with at least one positive
microbiological PA testing during the last 12 months before the Screening Visit.

- History of antibiotic treatment due to PA infection (not for eradication therapy)
during the last 12 months

- Concomitant treatment with inhaled tobramycin, colistin, or aztreonam (either cycled
or continuous) for at least 3 months at screening to treat PA infection. In case of
cycled antibiotic treatment, the treatment should start with an active cycle at the
day of randomisation (+/- 2 day) (together with the IMP intake). If taking tobramycin
cycled with another antibiotic, IMP should start on the active cycle of tobramycin.

- Stable CF disease as judged by the investigator.

- Willing to remain on a stable CF medication regimen (standard of care; SOC) during the
study.

- Women of child-bearing potential must have a negative urine pregnancy test at the
Screening and Randomisation Visit.

- Male and female patients must use acceptable contraceptive methods for the duration of
the study. Male and female patients without child-bearing potential (i.e. who are
infertile, surgically sterile or post-menopausal) are exempted from the contraceptive
requirements. For the purpose of this study acceptable contraception is defined as one
or a combination of the following:

- oral, injected, transdermal or implanted hormonal methods of contraception;
placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier
methods of contraception: condom or occlusive cap (diaphragm or cervical/vault
caps) with spermicidal foam/gel/film/cream/suppository.

- Capable of inhaling dry powder.

- Willing to sign informed consent

- Willing and able to follow the study procedures.

Exclusion Criteria:

- Use of hypertonic saline more than 2 times a day. If hypertonic saline is used, OligoG
inhalation should be taken at least 15 minutes after completion of hypertonic saline
therapy.

- Use of CFTR modulator therapies.

- Clinically significant abnormal findings of haematology or clinical chemistry;

- Elevated gamma GT (GGT), ALT, or AST > 3x the upper normal limit of normal (ULN)

- Bilirubin >2x ULN

- Abnormal renal function, with a creatinine clearance calculated <50ml/min

- Haemoglobin <10g/dL

- History of any comorbidity that, in the opinion of the investigator, might distort the
results of the study or cause an additional risk in administering study drug to the
patient.

- Pulmonary exacerbation within 28 days prior to randomisation.

- Change in CF therapy within 28 days before randomisation (first dose of IMP).

- Pregnant or breastfeeding females.

- History of allergic reactions to the ingredients of the IMP according to Common
Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4, including lactose and
milk protein.

- Patients unable to perform pulmonary function tests according to the ATS/ERS criteria.

- Uncontrolled or unstable chronic diseases (e.g. congestive heart failure, cardiac
arrhythmia, or psychiatric illness/social situations) that would limit the compliance
with study requirements in the opinion of the investigator.

- Any acute illness in the last 14 days

- History of, or planned organ transplantation.

- Lung infection with organisms associated with a more rapid decline in pulmonary status
(including, but not limited to Burkholderia cenocepacia, Burkholderia dolosa, and
Mycobacterium abscessus). For subjects who have had a history of a positive culture,
the following criteria will be used to determine whether the subject is free of
infection with such organisms:-

- The subject has not had a respiratory tract culture positive for these organisms
within the 12 months before the date of informed consent, and

- The subject has had at least 2 respiratory tract cultures negative for such
organisms within the 12 months before the date of informed consent, with the
first and last of these separated by at least 3 months, and the most recent one
within the 6 months before the date of informed consent.

- Active allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to
the Screening Visit, that has received pharmacological treatment for ABPA.

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

- Patients currently receiving any other investigational treatment, or who have
participated in a clinical study within 4 weeks (28 days) prior to the screening
visit.

- Current malignant disease (with the exception of basal cell carcinoma and cervical
neoplasia).

- Any medical or psychological condition, other than CF, which in the opinion of the
investigator exposes the patient to an unacceptably high risk.

- Patients with documented or suspected, clinically significant, alcohol or drug abuse
as per Investigator's discretion.



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

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: OligoG DPI

Primary Outcome(s)

FEV1 percent predicted [Time Frame: Baseline compared to 12 weeks]

Secondary Outcome(s)

Pulmonary exacerbation rate [Time Frame: 6 months before treatment, 6 months after treatment,]

Secondary ID(s)

ORDCF205

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AlgiPharma Australia Pty. Ltd.