Bronchodilator Therapy for Cystic Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen byJordan A Guenette, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of British Columbia

Approved in 3 Jurisdictions

Trial Summary

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

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

Treatment Details

Interventions

Placebo (Drug)
Salbutamol (Bronchodilator)

Trial OverviewThe 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: