Overview

A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis

Status:
Not yet recruiting
Trial end date:
2022-07-10
Target enrollment:
0
Participant gender:
All
Summary
Randomized, double blind, placebo controlled study. The study has two parts: Dose-finding part, followed by longer term follow-up (6 months)
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AlgiPharma AS
Collaborators:
Cystic Fibrosis Europe
Cystic Fibrosis Foundation
European Cystic Fibrosis Society
Imperial College London
University Hospital of Cologne
Criteria
Inclusion Criteria:

- Confirmed diagnosis of CF

- FEV1 at screening >40 and < 90% of predicted normal

- History of PA infection in last 12 m

- History of antibiotic treatment due tp PA infection (not for eradication) during last
12 m

- Concomitant inhaled tobramycin, colistin, aztreonam, or levoflaxin (cycled or
continuous)

- Stable CF disease

- Willing to remain on stable CF medication (Standard of care)

- Women of child-bearing potential must habe negative urine pregnany test

- Males & females must use acceptable contraception

- Capable of inhaling dry powder

- willing to sign informed consent

- willing and able to follow study procedures

Exclusion Criteria:

- Use of hypertonic saline > twice daily

- Clinically significant abnormal lab findings, except CRP. In case of high GGT values,
case will be discussed by experts before deciding

- History of comorbidity that may distort results or cause additional risk

- pulmonary exacerbation within 28 days prior to randomisation

- Change in CF therapy within 28 days prior to randomisation

- Burkholderia spp. finding within 12 m prior to screening

- pregnant or breast feeding females

- History of allergic reactions to IMP ingredients, incl milk protein

- Inability to perform lung function tests according to ATS/ ERS criteria

- Uncontrolled or unstable diseases that might limit compliance

- History of, or planned organ transplantation

- Allergic ABPA in the last 12 months prior to the screening visit

- Requirement for continuous oxygen supplementation

- Current participation in another clinical study

- medical condition, other than CFwhich exposes the patient to an unacceptably high risk

- Concurrent mlignant disease, except BCC and cervical neoplasia

- Clinically significant alcohol or drug abuse