Status:
TERMINATED
A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients with Cystic Fibrosis
Lead Sponsor:
AlgiPharma AS
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 includ...
Detailed Description
The alginate oligosaccharide OligoG CF-5/20 dry powder for inhalation (OligoG DPI) represents a novel therapeutic approach for patients with cystic fibrosis (CF). OligoG has been shown to release stag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03822455
Start Date
May 16 2019
End Date
July 10 2021
Last Update
October 28 2024
Active Locations (1)
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1
John Hunter Hospital
Newcastle, New South Wales, Australia