Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, open label, Phase IIa, multiple-ascending dose study in which subjects with mild to moderate Cystic Fibrosis and non CF bronchiectasis (n≤12) will be enrolled.

The safety and tolerability of S-1226 composed of PFOB with ascending doses of carbon dioxide (4%, 8%, and 12% CO2) administered twice daily in subjects with Cystic Fibrosis and non CF bronchiectasis will be evaluated. This will be followed by 5 day consecutive treatment using the highest tolerated dose of S1226. Participants can choose additional use of a further four weeks (28 days) of S-1226 therapy at home, using same or a lower tolerated dose.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SolAeroMed Inc.

Criteria

Inclusion Criterian(CF lung disease):

• Confirmed diagnosis of Cystic Fibrosis by sweat chloride concentration over 60 mosm/L and/or genotype analysis identifying two disease causing mutations

• Male or Female over the age of 14

• Followed in CF clinic at Foothills Hospital or Alberta Children's Hospital

• Known lung involvement

1. Recommended airway clearance daily or twice daily

2. FEV1, % predicted, between 40-80%

3. Evidence of Cystic Fibrosis lung involvement on Imaging, if available

• Competent at providing reliable and accurate pulmonary function studies

• Clinically stable - no pulmonary exacerbation of CF for which the patient has been hospitalized or received intravenous antibiotics for 4 weeks, no change in frequency of airway clearance

Exclusion Criteria CF lung disease:

• Gross Hemoptysis in previous 4 weeks

• Pneumothorax in previous 4 weeks

• Pregnancy or of child bearing age without adequate contraception

• Inability to produce acceptable and reproducible pulmonary function studies

• Evidence of elevated PaCO2 in recent 6 months

• Inability to perform airway clearance twice a day for the duration of the study

• History of anxiety/panic disorders

• Breast-feeding subject.

• Positive pregnancy test at screening.

• Subject, who in the opinion of the Investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.

Gross Hemoptysis in previous 4 weeks Pneumothorax in previous 4 weeks Pregnancy or of child bearing age without adequate contraception Inability to produce acceptable and reproducible pulmonary function studies Evidence of elevated PaCO2 in recent 6 months Inability to perform airway clearance twice a day for the duration of the study History of anxiety/panic disorders Breast-feeding subject. Positive pregnancy test at screening. Subject, who in the opinion of the Investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.

Inclusion Criteria (Non-CF bronchiectasis)

• Male or Female including and over the age of 14

• Known lung involvement

1. FEV1, % predicted, between 40-80%

2. Evidence of bronchiectasis on Imaging

• Competent at providing reliable and accurate pulmonary function studies

• Clinically stable - no pulmonary exacerbation for which the patient has been hospitalized or received intravenous antibiotics for 4 weeks

Exclusion Criteria (Non-CF bronchiectasis)

• Diagnosis of Cystic Fibrosis

• Active tuberculosis and/or non-tuberculosis mycobacterial infection

• Active allergic bronchopulmonary aspergillosis

• Traction bronchiectasis due to pulmonary fibrosis

• Gross Hemoptysis in previous 4 weeks

• Pneumothorax in previous 4 weeks

• Pregnancy or of child bearing age without adequate contraception

• Inability to produce acceptable and reproducible pulmonary function studies

• Evidence of elevated PaCO2 in recent 6 months

• Inability to perform airway clearance twice a day for the duration of the study

• History of anxiety/panic disorders

• Breast-feeding subject.

• Positive pregnancy test at screening.

• Subject, who in the opinion of the Investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.