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

NCT03822455 | Terminated Phase 2

• 1 other identifier: ORDCF205
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomised study of OligoG DPI compared to placebo DPI, both on top of standard-of-care, to assess safety, efficacy and tolerability. Adult patients with Cystic Fibrosis will be included in the study.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis

Outcome Measures

Primary Outcomes (1)

• FEV1 percent predicted

  Absolute change in percent Forced Expiratory Volume in one second,

  Baseline compared to 12 weeks

Secondary Outcomes (1)

• Pulmonary exacerbation rate

  6 months before treatment, 6 months after treatment,

Study Arms (2)

OligoG DPI

ACTIVE COMPARATOR

Active DPI containing the oligosaccharide OligoG and excipients

Drug: OligoG DPI

Placebo DPI

PLACEBO COMPARATOR

Placebo DPI containing lactose and excipients

Drug: OligoG DPI

Interventions

OligoG DPI DRUG

OligoG Dry Powder for Inhalation

OligoG DPI; Placebo DPI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AlgiPharma AS: lead

Study Sites (1)

John Hunter Hospital

Newcastle, New South Wales, Australia

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Peter Wark

  John Hunter Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomised to receive OligoG or placebo DPI. The investigational medicinal products will have identical appearance
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, double blind, placebo controlled

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 30, 2019
• Study Start: May 16, 2019
• Primary Completion: March 11, 2020
• Study Completion: July 10, 2021
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)