CF Bronchodilation

NCT03522831 | Active Not Recruiting

• 1 other identifier: H17-02029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Diseases; Cystic Fibrosis

Keywords

dyspnea; exercise endurance; lung disease

Outcome Measures

Primary Outcomes (1)

• Standardized dyspnea score at the highest equivalent submaximal exercise time achieved on both constant load exercise tests (i.e., iso-time).

  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.

  30 min post-dose.

Secondary Outcomes (14)

• Exercise endurance time on both constant load exercise tests.

  30 min post-dose.

• Ventilatory responses on both constant load exercise tests.

  30 min post-dose.

• Inspiratory capacity/dynamic hyperinflation on both constant load exercise tests.

  30 min post-dose.

• Operating lung volumes on both constant load exercise tests.

  30 min post-dose.

• Expiratory flow limitation on both constant load exercise tests.

  30 min post-dose.

Study Arms (2)

Salbutamol meter-dose inhaler

ACTIVE COMPARATOR

Inhalation of 400 μg salbutamol

Drug: Salbutamol

Placebo meter-dose inhaler

PLACEBO COMPARATOR

Inhalation of 400 μg placebo

Drug: Placebo

Interventions

Salbutamol DRUG

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

Salbutamol meter-dose inhaler

Placebo DRUG

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

Placebo meter-dose inhaler

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC Cardiopulmonary Exercise Physiology Laboratory

Vancouver, British Columbia, V6Z1Y6, Canada

Location

MeSH Terms

Conditions

Lung Diseases; Cystic Fibrosis; Dyspnea

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Jordan A Guenette, PhD

  University of British Columbia - Centre for Heart Lung Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: May 11, 2018
• Study Start: May 1, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CA (1)