CF Bronchodilation

Condition(s) studied

Investigational drug(s) / intervention(s)

Salbutamol: Administration of 400 μg meter-dose inhaler of salbutamol performed using large-volume spacer

Placebo: Administration of 400 μg meter-dose inhaler of placebo performed using large-volume spacer

Study summary

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.

Eligibility

Primary outcome measure(s)

• Standardized dyspnea score at the highest equivalent submaximal exercise time achieved on both constant load exercise tests (i.e., iso-time). — 30 min post-dose.
  Dyspnea rating measured using the Borg 0-10 category ratio scale. Parameters will be measured during visits 3 and 4. Each visit is separated by at least one week and a maximum of five weeks. Parameters will be measured at rest and during the exercise test following inhalation of drug or placebo.

Trial sites (1)

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