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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 June 2021
• Main ID: NCT03903913
• Date of registration: 15/02/2019
• Prospective Registration: Yes
• Primary sponsor: SolAeroMed Inc.
• Public title: Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis
• Scientific title: A Phase IIa Open Label Study to Evaluate the Safety, Tolerability and Efficacy of S-1226 Administered by Nebulization in Subjects With Mild to Moderate Cystic Fibrosis and Non CF Bronchiectasis
• Date of first enrolment: August 8, 2019
• Target sample size: 12
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03903913
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Mark Montgomery, MD
• Affiliation: University of Calgary

• Name: John Dennis, Phd

Key inclusion & exclusion 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.



Age minimum: 14 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bronchiectasis

Cystic Fibrosis

Intervention(s)

Drug: S-1226

Primary Outcome(s)

Treatment-emergent adverse events [Time Frame: 60 minutes]

Secondary Outcome(s)

Change from baseline in the respiratory domain of Cystic Fibrosis Questionnaire -Revised [Time Frame: Up to 4 weeks]

Change from baseline in percent of predicted forced expiratory volume in 1 Second [Time Frame: 60 minutes]

Secondary ID(s)

SAMi-03-1-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors