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

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ClinicalTrials.gov Identifier: NCT03822455
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
AlgiPharma Australia Pty. Ltd.
Information provided by (Responsible Party):
AlgiPharma AS

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: OligoG DPI Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, double blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients will be randomised to receive OligoG or placebo DPI. The investigational medicinal products will have identical appearance
Primary Purpose: Treatment
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)
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : January 3, 2020
Estimated Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Active Comparator: OligoG DPI
Active DPI containing the oligosaccharide OligoG and excipients
Drug: OligoG DPI
OligoG Dry Powder for Inhalation

Placebo Comparator: Placebo DPI
Placebo DPI containing lactose and excipients
Drug: OligoG DPI
OligoG Dry Powder for Inhalation




Primary Outcome Measures :
  1. FEV1 percent predicted [ Time Frame: Baseline compared to 12 weeks ]
    Absolute change in percent Forced Expiratory Volume in one second,


Secondary Outcome Measures :
  1. Pulmonary exacerbation rate [ Time Frame: 6 months before treatment, 6 months after treatment, ]
    rate of pulmonary exacerbations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822455


Contacts
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Contact: Hilde Morris +4792298921 hilde.morris@algipharma.com
Contact: Marieta Ryan +61398362653 marieta.ryan@algipharma.com

Locations
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Australia, New South Wales
John Hunter Hospital Recruiting
Newcastle, New South Wales, Australia
Contact: Peter Wark       peter.wark@newcastle.edu   
Sponsors and Collaborators
AlgiPharma AS
AlgiPharma Australia Pty. Ltd.
Investigators
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Principal Investigator: Peter Wark John Hunter Hospital

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Responsible Party: AlgiPharma AS
ClinicalTrials.gov Identifier: NCT03822455     History of Changes
Other Study ID Numbers: ORDCF205
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AlgiPharma AS:
cystic fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases