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
Summary
The investigational drug S-1226 is being developed as a possible treatment to aid airway mucous clearance in Cystic Fibrosis. An “investigational” drug is a drug that is being tested and is not approved for sale by Health Canada; it has been approved by Health Canada for this study based on safety data from an earlier trial performed in healthy adult volunteers as well as those with allergic asthma. SolAeroMed Inc. will be supplying the study drug. S-1226 is made of the gas carbon dioxide (CO2) and a liquid called perflubron. Carbon dioxide and perflubron are mixed together to make a mist that is inhaled (breathed in) from a nebulizer using a facemask that covers your nose and mouth. S-1226 has properties that open and lubricate the airways in order to clear the mucus out of the lungs. The study will evaluate the safety, tolerability and efficacy of S-1226 in subjects who have Cystic Fibrosis. The goal of this study is to determine whether daily courses of S-1226 can improve mucous clearance as well as relieve the airway constriction in patients with Cystic Fibrosis.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 14 to 50
Inclusion criteria:
You may be eligible to participate if you are:
1. Over the age of 14
2. Diagnosed with Cystic Fibrosis with lung involvement
3. Clinically stable
4. Able to perform the breathing tests (pulmonary function tests)
Doctors will also evaluate other criteria to make sure you qualify for the study.
Exclusion criteria:
You are not eligible to participate if you are:
1. Pregnant or of child-bearing age and not on appropriate contraception
2. Breast-feeding
3. Unable to perform the breathing tests (pulmonary function tests)
4. Someone who history of anxiety or panic disorders
Doctors will also evaluate other criteria to make sure you qualify for the study.
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
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Additional information
Contact information
Please contact the study coordinator Grishma Shrestha (email: grishma.shrestha@ucalgary.ca, phone: 403-220-3044)
Principal investigator:
Mark David Montgomery
Clinical trial:
Yes
REB-ID:
REB18-2069