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Bronchodilator
Bronchodilator Therapy for Cystic Fibrosis
N/A
Waitlist Available
Led By Jordan A Guenette, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 19 years or older
Currently non-smoking or a past smoking history of less than 20 pack-years
Must not have
Use of supplemental oxygen or desaturation less than 80% with exercise
History of solid organ transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 min post-dose.
Summary
This trial is studying whether a bronchodilator drug can help improve shortness of breath, exercise performance, and breathing responses in adults with cystic fibrosis.
Who is the study for?
This trial is for adults with cystic fibrosis who experience difficulty breathing and limited exercise capacity. Eligible participants must have a specific range of lung function, be between the ages of 19 and older, have a body mass index from 16 to 30, and cannot currently smoke or have a heavy past smoking history. People with certain infections or other diseases affecting breathing, those needing supplemental oxygen, or with a history of organ transplantation can't join.
What is being tested?
The study is testing whether Salbutamol—a bronchodilator medication that helps open up the airways in the lungs—can effectively reduce shortness of breath and improve exercise performance in CF patients compared to a placebo (a substance with no therapeutic effect).
What are the potential side effects?
While not specified here, common side effects of bronchodilators like Salbutamol may include tremors, headache, fast heart rate, dizziness, throat irritation and muscle cramps.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 19 years old or older.
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I am a non-smoker or have smoked less than 20 pack-years.
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I have been diagnosed with cystic fibrosis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need extra oxygen or my oxygen levels drop below 80% when I exercise.
Select...
I have had a solid organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 min post-dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 min post-dose.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Standardized dyspnea score at the highest equivalent submaximal exercise time achieved on both constant load exercise tests (i.e., iso-time).
Secondary study objectives
Airways resistance on both constant load exercise tests.
Arterial oxygen saturation on both constant load exercise tests.
Exercise stress test
+11 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Salbutamol meter-dose inhalerActive Control1 Intervention
Inhalation of 400 μg salbutamol
Group II: Placebo meter-dose inhalerPlacebo Group1 Intervention
Inhalation of 400 μg placebo
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,472 Previous Clinical Trials
2,489,600 Total Patients Enrolled
15 Trials studying Cystic Fibrosis
2,522 Patients Enrolled for Cystic Fibrosis
Jordan A Guenette, PhDPrincipal InvestigatorUniversity of British Columbia - Centre for Heart Lung Innovation
6 Previous Clinical Trials
166 Total Patients Enrolled
3 Trials studying Cystic Fibrosis
81 Patients Enrolled for Cystic Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition besides CF that affects my breathing or ability to exercise.I have a long-term lung infection with specific bacteria.You are not able to participate in exercise testing for medical reasons.I need extra oxygen or my oxygen levels drop below 80% when I exercise.I have had a solid organ transplant.I am 19 years old or older.My health condition is currently stable.I am a non-smoker or have smoked less than 20 pack-years.Your lung function test result (FEV1.0) is between 30% and 90% of what is expected for someone your age, height, and gender.I have been diagnosed with cystic fibrosis.Your body mass index (BMI) is between 16 and 30.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo meter-dose inhaler
- Group 2: Salbutamol meter-dose inhaler
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.