A Double-blind Placebo-controlled Crossover Study to Assess the Effects of Bronchodilation on Dyspnea, Ventilatory Responses, and Exercise Tolerance in Adults With Cystic Fibrosis

H17-02029

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.

2018-05-01

2024-12-31

2024-12-31

Active (not recruiting)

20

Inclusion Criteria: * Male or female with confirmed diagnosis of CF based on consensus criteria * Aged 19 years or older * Stable clinical status * Pre-bronchodilator FEV1.0 between 30% and 90% predicted * Body mass index between 16 and 30 kg/m2 * Currently non-smoking or a past smoking history of less than 20 pack-years Exclusion Criteria: * A disease other than CF that could importantly contribute to dyspnea or exercise limitation * Chronic airway infection with Mycobacterium abscessus, Burkholderia cepacia complex, or other organisms with infection control implications according to the treating physicians Contraindications to clinical exercise testing * Use of supplemental oxygen or desaturation less than 80% with exercise * History of solid organ transplantation

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2023-12-14