Recruiting
Phase 2

S-1226

Sponsor:

SolAeroMed Inc.

Code:

NCT03903913

Conditions

Cystic Fibrosis

Bronchiectasis

Eligibility Criteria

Sex: All

Age: 14 - 50

Healthy Volunteers: Not accepted

Interventions

S-1226

Study Details

Brief 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.

Conditions

Cystic Fibrosis

Bronchiectasis

Study ID

NCT03903913

Start date

Aug 8, 2019

Status verified date

Jun, 2021

Completion date

Aug, 2022

Anticipated

Primary completion date

Feb, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 50

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation Study

Subjects will receive up to three inhaled doses of S- 1226. Each dose will be administered over a 2-minute treatment period (with a minimum 2-minute break between treatments) with a nebulizer as follows.

Three S-1226 formulations will be tested sequentially:

  • S-1226(4%) is composed of 3 mL PFOB and 4% CO2
  • S-1226(8%) is composed of 3 mL PFOB and 8% CO2
  • S-1226(12%) is composed of 3 mL PFOB and 12% CO2

Each formulation will be administered by inhalation for a period of 2 minutes.The nebulizer will be filled with 3 mL of PFOB. The nebulizer is connected to a compressed medical gas mixture consisting of either 4%, 8% or 12%, CO2. A driving pressure of 20 psi will be used, producing a gas flow rate of 9 L/min.

experimental: Daily Dosing Study

Eligible subjects will receive S-1226 twice daily for 5 consecutive days. Subjects will receive up to three doses of S-1226 in the morning and afternoon, administered over three 2-minute periods with a Circulaire nebulizer, filled with one of the dosages outlined below, depending on the safety and tolerability data gathered from the dose escalation study for that particular subject.

  • S-1226(4%) is composed of 3 mL PFOB and 4% CO2
  • S-1226(8%) is composed of 3 mL PFOB and 8% CO2
  • S-1226(12%) is composed of 3 mL PFOB and 12% CO2

Interventions

S-1226

The drug product S-1226 has two components delivered by inhalation. It is a mixture of perfluorooctylbromide (PFOB) nebulized with a medical gas mixture containing CO2. The PFOB component remains the same but the medical gas component contains 4%, 8% or 12% CO2.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

John Dennis, Phd

403-689-5989jdennis@solaeromed.com

Francis Green, MBChB, MD

403-220-4514fgreen@ucalgary.ca

Locations

Adult Cystic Fibrosis Clinic at the Foothills Hospital

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Grishma Shrestha, MD

4032203044grishma.shrestha@ucalgary.ca

Pediatric Cystic Fibrosis Clinic at Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Grishma Shrestha, MD

4032203044grishma.shrestha@ucalgary.ca

More Information

Sponsor

SolAeroMed Inc.

Last update posted

Jun 16, 2021

Last verified

Jun, 2021

Keywords

  • Asthma
  • Carbon dioxide
  • Perfluorocarbon
  • Mucolytic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SolAeroMed Inc. on 2021-06-16.