Bronchodilator Therapy for Cystic Fibrosis
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What evidence supports the effectiveness of the drug Salbutamol for treating cystic fibrosis?
Is salbutamol safe for use in humans?
Salbutamol, also known as albuterol, has been used for many years to treat breathing problems and is generally considered safe. Studies show it has fewer side effects compared to other treatments like epinephrine, especially when inhaled, making it a recommended option for children with asthma.16789
How is the drug Salbutamol unique for treating cystic fibrosis?
Salbutamol is a bronchodilator that helps open up the airways in the lungs, and while it is commonly used for asthma, its use in cystic fibrosis is still debated. The development of long-acting versions of bronchodilators like Salbutamol offers potential benefits for cystic fibrosis patients, as they may provide longer-lasting relief compared to traditional short-acting options.110111213
What is the purpose of this trial?
It is estimated that one in every 3,600 children in Canada has cystic fibrosis (CF). CF is a genetic disease that affects the glands that produce mucus and sweat. In CF, mucus production increases and the mucus becomes thick and sticky. This can block the airways, making it difficult to breathe. Mucus production also causes bacteria to grow, which can lead to infections in the lungs. Individuals with CF suffer from shortness of breath, wheezing, cough, and poor exercise capacity. There are limited treatment options to reduce shortness of breath in these individuals. Some medications known as bronchodilators are commonly prescribed to reduce breathlessness in patients with CF. These drugs help open the airways making it easier to breathe. Unfortunately, there is limited scientific proof that these drugs can reduce shortness of breath and improve exercise capacity in patients with CF. As a result, some experts have recommended that these drugs should not be prescribed for patients with CF. The purpose of this study is to examine the effects of a bronchodilator on shortness of breath, exercise performance, and breathing responses compared to a placebo drug in adults with CF.
Research Team
Jordan A Guenette, PhD
Principal Investigator
University of British Columbia - Centre for Heart Lung Innovation
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Medical history screening, chronic activity-related dyspnea, quality of life, and physical activity questionnaires, anthropometric measurements, pulmonary function assessment, and a symptom-limited incremental cycle exercise test
Treatment
Participants undergo constant-load cycle exercise tests with inhalation of either 400 μg salbutamol or placebo in a crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Salbutamol
Salbutamol is already approved in European Union, United States, Canada for the following indications:
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Exercise-induced bronchoconstriction
- High blood potassium levels
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Exercise-induced bronchoconstriction
- High blood potassium levels
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Exercise-induced bronchoconstriction
- High blood potassium levels
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor