A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02453789
• Date of registration: 14/05/2015
• Prospective Registration: No
• Primary sponsor: AlgiPharma AS
• Public title: A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection SMR-2591
• Scientific title: A Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp.
• Date of first enrolment: February 2015
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02453789
• 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

Germany

Contacts

• Name: Rainald Fischer, MD, PD
• Affiliation: Pneumologische Praxis Pasing

Key inclusion & exclusion criteria

Inclusion Criteria:

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

- Clinical features consistent with the diagnosis of CF; AND

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

- Genotypic confirmation of CFTR mutation

- Aged 18 years or older

- Ability to provide sputum samples for microbiological evaluation throughout the study
either spontaneously or induced.

- Chronic colonization with Burkholderia spp. defined as at least two positive
microbiological cultures in expectorated sputum within the last 12 months from Visit
1.

- Use of inhaled aztreonam three times daily in a 4 weeks on/off cycle treatment regimen
or a continuous intake regimen for at least 4 weeks before screening visit. For on/off
cycles, screening visit should take place in the off phase. Randomization visit should
take place the first day "on" to harmonize the aztreonam inhalation period with the
IMP intake period.

- Willingness to stop treatment with other inhaled antibiotics.

- At Screening 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.

- FEV1 greater than 25% of the predicted normal value following adjustment for age,
gender, and height according to the Global Lung Initiative

- 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 are exempt from the contraceptive
requirements.

- Provision of 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 at Day 98.

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

- Prohibited medications within 7 days prior to Day 0. Concomitant administration of
inhaled mannitol or hypertonic saline within 7 days prior to Day 0.

- Concomitant use of inhaled antibiotics other than aztreonam.

- Pulmonary exacerbation within 28 days of 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.

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

- Inability or unwillingness to provide sputum samples for microbiological evaluation
throughout the study either spontaneously or induced by means of using inhaled
hypertonic saline.

- 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 at Screening.

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

- Subjects with documented or suspected, clinically significant, alcohol or drug abuse,
as determined by the Investigator.

- 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.

- Patients not willing/able to follow the study instructions.

- Resistance to aztreonam, or intolerance to aztreonam or any of its excipients.



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

Health Condition(s) or Problem(s) studied

Burkholderia Infection

Cystic Fibrosis

Intervention(s)

Drug: Placebo

Drug: Alginate oligosaccharide

Primary Outcome(s)

Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum. [Time Frame: 28 days, i.e. at start and end of treatment]

Secondary Outcome(s)

Clinical safety as measured by FEV1 (Forced Expiratory Volume in 1 second) [Time Frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112]

Clinical safety as measured by ECG [Time Frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112]

Clinical safety as measured by blood oxygen saturation [Time Frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112]

Clinical safety as measured by vital signs [Time Frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112]

Secondary ID(s)

SMR-2591

Source(s) of Monetary Support

Please refer to primary and secondary sponsors