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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 below
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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:
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I need extra oxygen or my oxygen levels drop below 80% when I exercise.
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I have had a solid organ transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 min post-dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 min post-dose. for reporting.

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 more

Trial 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
1,466 Previous Clinical Trials
2,485,436 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

Salbutamol (Bronchodilator) Clinical Trial Eligibility Overview. Trial Name: NCT03522831 — N/A
Cystic Fibrosis Research Study Groups: Placebo meter-dose inhaler, Salbutamol meter-dose inhaler
Cystic Fibrosis Clinical Trial 2023: Salbutamol Highlights & Side Effects. Trial Name: NCT03522831 — N/A
Salbutamol (Bronchodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03522831 — N/A
~0 spots leftby Dec 2024
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