Evaluating Sensations of Breathlessness in Patients With Cystic Fibrosis

NCT01799642 | Completed

• 1 other identifier: H13-00262
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Shortness of breath (dyspnea) during exercise is a major source of distress and is a commonly reported symptom in patients with cystic fibrosis (CF). Due to the investigators' poor understanding of how dyspnea develops, there are no treatments that consistently reduce dyspnea in this population. The investigators aim to acquire a more comprehensive understanding of the physiological mechanisms of exertional dyspnea in CF patients. This study will likely identify an important physiological mechanism of dyspnea in CF and may contribute to the development and use of effective treatments to reduce dyspnea in this population. The central hypothesis is that the impaired tidal volume (VT) response during exercise in CF, in the setting of increased ventilatory demand will give rise to different qualitative descriptions of exertional dyspnea compared with healthy age and sex-matched controls. Specifically, CF patients will select "increased work and effort" as their dominant descriptor of dyspnea up to the VT inflection/plateau. Beyond this point, CF patient's dominant descriptor will become "unsatisfied inspiration." In contrast, healthy control participants will report "increased work and effort" throughout all phases of exercise and will not report "unsatisfied inspiration", even after the VT inflection/plateau.

Conditions

Lung; Disease; Cystic Fibrosis; Healthy

Keywords

dyspnea; exercise; cystic fibrosis; neuromechanical dissociation

Outcome Measures

Primary Outcomes (1)

• To determine if dyspnea is qualitatively and quantitatively different in patients with cystic fibrosis compared with age and sex-matched healthy controls during exercise

  Included will be 20 patients with cystic fibrosis (CF) who have no other pulmonary or extra-pulmonary limitation to exercise, as well as 20 healthy age and sex-matched control participants. All participants (CF and control) will perform an incremental symptom-limited cardio-pulmonary exercise test while detailed cardio-respiratory responses, dyspnea responses, muscle oxygenation and muscle hemodynamic data are measured.

  Parameters will be measured during the 1 visit.

Secondary Outcomes (1)

• To determine if the dyspnea responses can be explained by differences in the ventilatory response to exercise.

  Parameters will be measured during the 1 visit.

Study Arms (2)

Cystic Fibrosis Patients

Participants with Cystic Fibrosis

Healthy Controls

Participants who do not have cystic fibrosis and are otherwise healthy.

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The CF patients will be recruited from the St. Paul's Hospital Adult CF Clinic. Healthy control participants will be recruited from the Vancouver area.

You may qualify if:

• CF patients (confirmed based on abnormal sweat chloride testing and/or CF Transmembrane Conductance Regulator (CFTR) genotyping)
• Between the ages of 19 to 50 (inclusive)
• Stable clinical status (CF: no changes in therapy in the past 4 weeks)
• Forced Expiratory Volume in 1 second (FEV1.0) \>40% predicted
• Body mass index greater than 18 or less than 30
• Currently non-smoking or a past smoking history of less than 20 pack-years
• Able to read and understand English

You may not qualify if:

• A disease other than CF that could contribute to dyspnea or exercise limitation
• Having either of the chronic infections Mycobacterium abscessus or Burkholderia cepacia complex
• Contraindications to clinical exercise testing
• Use of supplemental oxygen or desaturation less than 85% with exercise
• Diagnosis of pneumothorax in the past 4 weeks

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC James Hogg Research Centre, St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

MeSH Terms

Conditions

Lung Diseases; Cystic Fibrosis; Dyspnea; Motor Activity

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; Behavior

Study Officials

• Jordan A Guenette, PhD

  UBC James Hogg Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 27, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

CA (1)