20 Participants Needed

Bronchodilator Therapy for Cystic Fibrosis

SS
Overseen BySatvir S Dhillon, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that albuterol (another name for salbutamol) can improve lung function in patients with cystic fibrosis, as seen in a study where patients experienced significant improvements in their breathing after using albuterol compared to a placebo.12345

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

JA

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

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.
See 3 more

Exclusion 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.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

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

1 week
1 visit (in-person)

Treatment

Participants undergo constant-load cycle exercise tests with inhalation of either 400 μg salbutamol or placebo in a crossover design

5 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Salbutamol
Trial Overview 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).
Participant Groups
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

Salbutamol is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Ventolin for:
  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Exercise-induced bronchoconstriction
  • High blood potassium levels
🇺🇸
Approved in United States as Albuterol/Ventolin for:
  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Exercise-induced bronchoconstriction
  • High blood potassium levels
🇨🇦
Approved in Canada as Ventolin for:
  • 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

Trials
1,506
Recruited
2,528,000+

Findings from Research

Endotracheal administration of albuterol was successfully used in a 67-year-old woman with severe asthma, leading to significant improvement in her clinical status and arterial blood gases.
This method of delivering albuterol directly to the bronchial tree is effective for intubated asthmatic patients, allowing for rapid recovery and extubation.
Treatment of asthma-related respiratory arrest with endotracheal albuterol (salbutamol).Verbeek, PR., Gareau, AB., Rubes, CJ.[2019]
In a double-blind controlled trial involving nine patients with severe chronic airway obstruction, all participants preferred nebulized salbutamol over placebo, indicating its potential efficacy in improving symptoms.
Patients showed significant improvements in morning and evening peak flow measurements and reported lower symptom scores for breathlessness, wheezing, and sputum production during the active treatment period, suggesting that nebulized salbutamol may be beneficial for those not responding to conventional therapies.
Domiciliary nebulised salbutamol solution in severe chronic airway obstruction.Wilson, RS., Connellan, SJ.[2019]
A study involving 10 healthy volunteers found no significant differences in lung bioavailability between generic (Salamol, Salbulin) and innovator (Ventolin) formulations of inhaled salbutamol, indicating similar effectiveness in delivering the medication to the lungs.
All formulations produced comparable plasma salbutamol levels and urinary excretion rates, suggesting that both generic and innovator inhalers can be used interchangeably without loss of efficacy.
Lung bioavailability of generic and innovator salbutamol metered dose inhalers.Clark, DJ., Gordon-Smith, J., McPhate, G., et al.[2019]

References

Treatment of asthma-related respiratory arrest with endotracheal albuterol (salbutamol). [2019]
Domiciliary nebulised salbutamol solution in severe chronic airway obstruction. [2019]
Effects of standard and high doses of salmeterol on lung function of hospitalized patients with cystic fibrosis. [2019]
[Effectiveness of salbutamol powder (Ventodisk Glaxo) compared to dosed aerosols (sultanol)]. [2016]
Lung bioavailability of generic and innovator salbutamol metered dose inhalers. [2019]
Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered-dose inhaler in patients with asthma. [2019]
Inhaled salbutamol (albuterol) vs injected epinephrine in the treatment of acute asthma in children. [2019]
Safety outcomes of salbutamol: A systematic review and meta-analysis. [2023]
Mechanisms by which systemic salbutamol increases ventilation. [2022]
Comparison of spray congealing and melt emulsification methods for the incorporation of the water-soluble salbutamol sulphate in lipid microparticles. [2013]
11.United Statespubmed.ncbi.nlm.nih.gov
Long-acting bronchodilators in cystic fibrosis. [2019]
Nebulized salbutamol (Asmasal) in Thai children with asthma: comparison of three doses. [2016]
13.United Statespubmed.ncbi.nlm.nih.gov
The effect of a holding chamber on albuterol metered-dose inhaler product differences. [2017]
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