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S-1226 for Cystic Fibrosis

Phase 2
Waitlist Available
Led By Mark Montgomery, MD
Research Sponsored by SolAeroMed Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights

Study Summary

This study is evaluating whether a drug called S-1226 can improve lung function in people with Cystic Fibrosis and non CF bronchiectasis.

Eligible Conditions
  • Cystic Fibrosis
  • Bronchiectasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment-emergent adverse events
Secondary outcome measures
Change from baseline in percent of predicted forced expiratory volume in 1 Second
Cystic Fibrosis
Other outcome measures
Change from baseline in Forced Expiratory Flow at 25-75%
Vital capacity
Change from baseline in Inspiratory Capacity
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Escalation StudyExperimental Treatment1 Intervention
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.
Group II: Daily Dosing StudyExperimental Treatment1 Intervention
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

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Who is running the clinical trial?

SolAeroMed Inc.Lead Sponsor
4 Previous Clinical Trials
126 Total Patients Enrolled
Mark Montgomery, MDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
78 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis
2019. "Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03903913.
All > Bronchiectasis > Cystic Fibrosis
~2 spots leftby Apr 2025
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