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CF Bronchodilation

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ClinicalTrials.gov Identifier: NCT03522831
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Jordan Guenette, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Lung Diseases Cystic Fibrosis Drug: Salbutamol Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020


Arm Intervention/treatment
Active Comparator: Salbutamol meter-dose inhaler
Inhalation of 400 μg salbutamol
Drug: Salbutamol
Administration of 400 μg meter-dose inhaler of salbutamol performed using large-volume spacer

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




Primary Outcome Measures :
  1. 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. ]
    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.


Secondary Outcome Measures :
  1. Exercise endurance time on both constant load exercise tests. [ Time Frame: 30 min post-dose. ]
    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 during the exercise test following inhalation of drug or placebo.

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

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

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

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

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

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

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

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

  10. Qualitative dyspnea measurements on both constant load exercise tests. [ Time Frame: 30 min post-dose. ]
    Participants will be asked to select the most applicable dyspnea descriptor(s) after the intensity ratings using the following 3 descriptors: (1) "my breathing requires more work and effort" (work and effort); (2) "I cannot get enough air in" (unsatisfied inspiration); (3) "I cannot get enough air out" (unsatisfied expiration). None to all three of the descriptors can be chosen at any one time. Multiple selections are permitted as long as they apply equally. Upon exercise cessation, participants will be asked to verbalize their main reason(s) for stopping exercise (i.e., breathing discomfort, leg discomfort, combination of breathing and legs, or some other reason) and to select qualitative descriptors of breathlessness using an established questionnaire. 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.

  11. Spirometry on both constant load exercise tests. [ Time Frame: 10 min post-dose. ]
    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 following inhalation of drug or placebo.

  12. Plethysmographic lung volumes on both constant load exercise tests. [ Time Frame: 10 min post-dose. ]
    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 following inhalation of drug or placebo.

  13. Airways resistance on both constant load exercise tests. [ Time Frame: 10 min post-dose. ]
    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 following inhalation of drug or placebo.

  14. Impulse oscillometry on both constant load exercise tests. [ Time Frame: 10 min post-dose. ]
    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 following inhalation of drug or placebo.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522831


Contacts
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Contact: Satvir S Dhillon, MSc 604-806-8835 satvir.dhillon@hli.ubc.ca

Locations
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Canada, British Columbia
UBC Cardiopulmonary Exercise Physiology Laboratory Recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Contact: Satvir Dhillon, MSc    6048068835    satvir.dhillon@hli.ubc.ca   
Principal Investigator: Jordan Guenette, PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Jordan A Guenette, PhD University of British Columbia - Centre for Heart Lung Innovation

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Responsible Party: Jordan Guenette, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03522831     History of Changes
Other Study ID Numbers: H17-02029
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jordan Guenette, University of British Columbia:
dyspnea
exercise endurance
lung disease

Additional relevant MeSH terms:
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Anti-Asthmatic Agents
Fibrosis
Cystic Fibrosis
Lung Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action