A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02157922
• Date of registration: 04/06/2014
• Prospective Registration: Yes
• Primary sponsor: AlgiPharma AS
• Public title: A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis SMR-2984
• Scientific title: A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis
• Date of first enrolment: October 2014
• Target sample size: 65
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02157922
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Denmark, Germany, Norway, Sweden, United Kingdom

Contacts

• Name: Tacjana Pressler, PhD MD
• Affiliation: Rigshospitalet, Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female with a confirmed diagnosis of cystic fibrosis defined by:

1. Clinical features consistent with the diagnosis of CF AND Sweat chloride =60
mmol/L by pilocarpine iontophoresis; OR

2. Genotypic confirmation of CFTR mutation

- Aged 18 years or older

- Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or
cough swab within 24 months prior to Screening

- FEV1 between 40%-100%

- At Screening no clinical or laboratory findings suggestive of significant pulmonary
illness, other than CF

- Female subjects of child bearing potential and sexually active male subjects must use
contraception

- Provision written informed consent

Exclusion Criteria:

- Changes in underlying therapy within the 14 days prior to Day 0. Subjects must be
willing to remain on the same underlying stable therapy regimens for the duration of
the study until the final follow-up visit.

- Changes in physiotherapy technique or schedule within 14 days prior to Day 0.

- Prohibited medications within 7 days prior to Day 0.

- Pulmonary exacerbation within 28 days of Screening.

- Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough
swab documented within 12 months prior to Screening.

- Lactose intolerance/milk allergy.

- On-going acute illness. Subjects must not have needed an outpatient visit,
hospitalization or required any change in therapy for other pulmonary disease between
Screening and Day 0.

- History of, or planned organ transplantation.

- Treatment for Allergic bronchopulmonary aspergillosis (ABPA).

- Requirement for continuous (24 hour/day) oxygen supplementation.

- Diagnosed with the G551D-mutation, and currently on concomitant treatment with
Ivacaftor (Kalydeco).

- Concomitant administration of inhaled mannitol or hypertonic saline within 7 days
prior to Day 0 (Visit 2).

- Initiation of cycled, inhaled tobramycin (TOBI) and Colistin less than 4 months prior
to Screening (Visit 1). Note: Chronic TOBI and Colistin users are allowed to
participate in this study, but subjects who have recently initiated chronic TOBI or
Colistin should have at least 2 cycles of TOBI or Colistin respectively in the
preceding 4 months before being enrolled in this study. Treatment should be phased in
line with the antibiotic treatment.

- Concomitant use of all other marketed antibiotic agents is permitted, providing
subjects are willing to remain on the same regimens within the 28 days immediately
prior to Day 0 and for the entire duration of the study (until the follow-up visit).

- Clinically significant abnormal findings on haematology or clinical chemistry. In
addition, any value = 3 x the upper limit of normal will exclude the subject from
participating in the study.

- Subjects unable to perform pulmonary function tests according to the ATS/ERS criteria.

- Pregnant or breast-feeding women. A negative urine pregnancy test must be demonstrated
in females of child-bearing potential (Section 4.2.9) at Screening.

- Subjects who have participated in any interventional clinical trial within the 28 days
prior to Day 0 (Visit 2).

- Subjects with documented or suspected, clinically significant, alcohol or drug abuse.

- Current malignant disease (with the exception of basal cell carcinoma and cervical
neoplasia).

- Any serious or active medical or psychiatric illness, which in the opinion of the
Investigator, would interfere with subject treatment, assessment, or compliance with
the protocol.

- DPI intolerance, active or placebo

For MCC sites only:

- Smoking. A negative Cotinine test must be demonstrated at Screening

- Subjects who have any non-removable metal objects such as metal plates, screws etc in
their head, neck, chest or abdominal area

- Subjects for whom participation in this study will exceed the limits of total
radiation exposure allowed in any 12 month period (5 mSv), or will exceed 10 mSv over
any three year period.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: alginate oligosaccharide

Primary Outcome(s)

FEV1 (Forced Expiratory Volume in 1 second) [Time Frame: 28 days, i.e. start and end of treatment periods]

Secondary Outcome(s)

Mucociliary and cough clearance [Time Frame: 28 days, i.e. start and end of treatment periods]

Secondary ID(s)

SMR-2984

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Smerud Medical Research International AS

Eurostars