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