Clinical trial NCT01465529 (phase 1/phase 2, status: completed)
Conditions: cystic fibrosis
ICD codes: E84.9, Z14.1, E84.0, E84.11, E84.8, E84.19, P09.4
Drugs: oligog cf-5/20, saline
SMILES: COCCC1=CC=C(OCC(O)CNC(C)C)C=C1
Eligibility criteria:

        Inclusion Criteria:

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

               -  Clinical features consistent with the diagnosis of CF [(Rosenstein BJ and Cutting
                  GR 1998)]; AND

               -  Sweat chloride ≥60 mmol/L by pilocarpine iontophoresis; OR

               -  Genotypic confirmation of CFTR mutation

          -  Aged 18 years or older

          -  Ability to provide samples for microbiological evaluation throughout the study. Note:
             sputum samples are preferred however cough swabs may be performed on occasions where
             sputum cannot be collected.

          -  Positive microbiological finding of Pseudomonas aeruginosa in expectorated sputum or
             cough swab documented within 24 months prior to Screening (Visit 1).

          -  FEV1 must, at Screening (Visit 1), be between 35%-80% of the predicted normal value
             following adjustment for age, gender, and height according to the Knudson equation
             [(Knudson RJ., Lebowitz MD., et al 1983)].

          -  At Screening (Visit 1), no clinical or laboratory findings suggestive of significant
             pulmonary illness, other than CF, which in the opinion of the investigator would
             preclude participation in the study.

          -  Female subjects of child bearing potential and male subjects participating in the
             study who are sexually active must use acceptable contraception. Female subjects
             documented as being of non child-bearing potential (Section 4.2.8) are exempt from the
             contraceptive requirements. For the purpose of this study acceptable contraception is
             defined as:

               -  oral, injected or implanted hormonal methods of contraception;OR

               -  placement of an intrauterine device (IUD) or intrauterine system (IUS);OR

               -  barrier methods of contraception: condom or occlusive cap (diaphragm or
                  cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

          -  Provision written informed consent

        Exclusion Criteria:

          -  Changes in underlying therapy (e.g., pulmonary massage therapy, bronchodilators,
             NSAIDs, antibiotic agents, pancreatic enzyme preparations, nutritional supplements and
             DNase within the 21 days prior to Day 1 (Visit 2). 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 at Day 111.

          -  Changes in physiotherapy technique or schedule within 14 days prior to Day 1 (Visit
             2).

          -  Prohibited medications within 7 days prior to Day 1 (Visit 2). Prohibited medications
             are described in Section 5.6

          -  Pulmonary exacerbation within 28 days of Screening (Visit 1).

          -  Positive microbiological finding of Burkholderia sp. in expectorated sputum or cough
             swab documented within 12 months prior to Screening (Visit 1).

          -  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 (Visit 1) and Day 1 (Visit 2).

          -  History of, or planned organ transplantation.

          -  Allergic bronchopulmonary aspergillosis (ABPA) in the last 12 months prior to
             Screening (Visit 1), defined as having received treatment for ABPA.

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

          -  Concomitant administration of inhaled mannitol or hypertonic saline within 7 days
             prior to Day 1 (Visit 2).

          -  Initiation of cycled, inhaled tobramycin (TOBI) less than 4 months prior to Screening
             (Visit 1). Note: Chronic TOBI users are allowed to participate in this study, but
             subjects who have recently initiated chronic TOBI should have at least 2 cycles of
             TOBI in the preceding 4 months before being enrolled in this study. Chronic TOBI
             subjects should be starting an 'off- TOBI' period at Day 1 (Visit 2) so there will be
             no concomitant dosing of TOBI and assigned study medication.

          -  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 4.2.8) at Screening (Visit 1).

          -  Subjects who have participated in any interventional clinical trial within the 28 days
             prior to Day 1 (Visit 2).

          -  Subjects with documented or suspected, clinically significant, alcohol or drug abuse.
             The determination of clinical significance will be determined by the Investigator.

          -  Known allergies or intolerance to alginates (e.g., foods and food additives based on
             seaweed extracts).

          -  Current malignant disease (with the exception of basal cell carcinoma; BCC).

          -  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.