Cystic FibrosisPhase 2NCT03822455
A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients with Cystic Fibrosis
A Phase 2 study testing OligoG DPI in people with Cystic Fibrosis, run by AlgiPharma AS at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- OligoG DPI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 16 May 2019to 10 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the 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 stagnant mucus, modulate sputum rheology and disrupt the biofilm formation often typically observed in CF. These properties will in turn facilitate mucus clearance and promote effectiveness of antibiotic therapy against the chronic pulmonary infections characteristic of CF.
Patients with CF (age 18 years or older) will be eligible to participate in this study.
The design will be a randomised, blinded, placebo-controlled pilot study for proof of concept that OligoG DPI can improve lung function in adult CF patients. Study medication will be given twice daily for twelve weeks on top of standard of care (SOC). Thirty-three patients will be included, out of which twenty-two shall receive OligoG, and eleven shall receive placebo.
After all patients have completed the 12 week double blind treatment period, all patients will be offered open-label OligoG twice daily, in addition to standard of care, for 12 months.
The primary endpoint will be absolute change i percent predicted FEV1
Exploratory parameters will include sputum microbiology.
- Conditions
- Cystic Fibrosis
- Being tested
- OligoG DPI
- Keywords
- cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OligoG DPIDrug
OligoG Dry Powder for Inhalation
| Study group | Role | What they receive |
|---|---|---|
| OligoG DPI | Active comparator | Active DPI containing the oligosaccharide OligoG and excipients Receives: Drug: OligoG DPI |
| Placebo DPI | Placebo comparator | Placebo DPI containing lactose and excipients Receives: Drug: OligoG DPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 percent predicted
Absolute change in percent Forced Expiratory Volume in one second,
Measured: Baseline compared to 12 weeks
Secondary outcomes (1)
Pulmonary exacerbation rate
rate of pulmonary exacerbations
Measured: 6 months before treatment, 6 months after treatment,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start16 May 2019
- Primary completion11 Mar 2020
- Study completion10 Jul 2021
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlgiPharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Wark, Principal investigator, John Hunter Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822455
- Sponsor's protocol ID
- ORDCF205
- Status last verified
- Oct 2024
- First submitted
- 29 Jan 2019
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03822455
- Acronym / sponsor ID
- ORDCF205
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AlgiPharma ASIndustry (pharma, biotech, devices)
- Study start
- 16 May 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 stagnant mucus, modulate sputum rheology and disrupt the biofilm formation often typically observed in CF. These properties will in turn facilitate mucus clearance and promote effectiveness of antibiotic therapy against the chronic pulmonary infections characteristic of CF.
Patients with CF (age 18 years or older) will be eligible to participate in this study.
The design will be a randomised, blinded, placebo-controlled pilot study for proof of concept that OligoG DPI can improve lung function in adult CF patients. Study medication will be given twice daily for twelve weeks on top of standard of care (SOC). Thirty-three patients will be included, out of which twenty-two shall receive OligoG, and eleven shall receive placebo.
After all patients have completed the 12 week double blind treatment period, all patients will be offered open-label OligoG twice daily, in addition to standard of care, for 12 months.
The primary endpoint will be absolute change i percent predicted FEV1
Exploratory parameters will include sputum microbiology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| OligoG DPI | Active comparator | Drug: OligoG DPIActive DPI containing the oligosaccharide OligoG and excipients |
| Placebo DPI | Placebo comparator | Drug: OligoG DPIPlacebo DPI containing lactose and excipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (25 listed)
- 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;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OligoG DPIOligoG Dry Powder for Inhalation | Drug | OligoG DPI, Placebo DPI |
Primary outcome
FEV1 percent predicted
Time frame: Baseline compared to 12 weeks
Absolute change in percent Forced Expiratory Volume in one second,
1 secondary outcome
Pulmonary exacerbation rate
Time frame: 6 months before treatment, 6 months after treatment,
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Wark principal investigator
John Hunter Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OligoG DPI in people with Cystic Fibrosis, run by AlgiPharma AS at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 percent predicted (time frame: Baseline compared to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.