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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03822455




Registration number
NCT03822455
Ethics application status
Date submitted
29/01/2019
Date registered
30/01/2019

Titles & IDs
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)
Secondary ID [1] 0 0
ORDCF205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OligoG DPI

Active comparator: OligoG DPI - Active DPI containing the oligosaccharide OligoG and excipients

Placebo comparator: Placebo DPI - Placebo DPI containing lactose and excipients


Treatment: Drugs: OligoG DPI
OligoG Dry Powder for Inhalation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FEV1 percent predicted
Timepoint [1] 0 0
Baseline compared to 12 weeks
Secondary outcome [1] 0 0
Pulmonary exacerbation rate
Timepoint [1] 0 0
6 months before treatment, 6 months after treatment,

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/07/2021
Actual
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
- Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AlgiPharma AS
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
AlgiPharma Australia Pty. Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Wark
Address 0 0
John Hunter Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03822455