CF Bronchodilation

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03522831
• Date of registration: 19/03/2018
• Prospective Registration: Yes
• Primary sponsor: University of British Columbia
• Public title: CF Bronchodilation
• Scientific title: 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
• Date of first enrolment: May 1, 2018
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03522831
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Jordan A Guenette, PhD
• Affiliation: University of British Columbia - Centre for Heart Lung Innovation

Key inclusion & exclusion criteria

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



Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Lung Diseases

Intervention(s)

Drug: Salbutamol

Drug: Placebo

Primary Outcome(s)

Standardized dyspnea score at the highest equivalent submaximal exercise time achieved on both constant load exercise tests (i.e., iso-time). [Time Frame: 30 min post-dose.]

Secondary Outcome(s)

Impulse oscillometry on both constant load exercise tests. [Time Frame: 10 min post-dose.]

Inspiratory capacity/dynamic hyperinflation on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Plethysmographic lung volumes on both constant load exercise tests. [Time Frame: 10 min post-dose.]

Qualitative dyspnea measurements on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Ventilatory responses on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Breathing patterns on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Metabolic responses on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Standardized leg discomfort score on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Airways resistance on both constant load exercise tests. [Time Frame: 10 min post-dose.]

Spirometry on both constant load exercise tests. [Time Frame: 10 min post-dose.]

Exercise endurance time on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Expiratory flow limitation on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Operating lung volumes on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Arterial oxygen saturation on both constant load exercise tests. [Time Frame: 30 min post-dose.]

Secondary ID(s)

H17-02029

Source(s) of Monetary Support

Please refer to primary and secondary sponsors