Exercise-Induced Bronchospasm in Cystic Fibrosis

Exercise is an important clinical feature in cystic fibrosis. Better exercise capacity has been associated with better patient outcomes and quality of life. Exercise-induced bronchospasm is a condition, often associated with asthma, which may make exercise difficult. The role that exercise-induced bronchospasm has in people with cystic fibrosis is unknown. This study is designed to determine how often exercise-induced bronchospasm occurs in cystic fibrosis.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Bronchospasm

Detailed Description

We anticipate that Visit 1 will take approximately three hours. This will include obtaining informed consent, completing baseline demographic and quality of life questionnaires, brief physical exam, measuring exhaled nitric oxide level, skin allergy testing, obtaining blood and sputum samples, and performing pulmonary function testing before and after bronchodilators.

Visit 2 will take approximately two and one-half hours. This will include performing Eucapnic Voluntary Hyperventilation, measuring exhaled nitric oxide levels, and obtaining blood and sputum samples.

Visit 3 will take approximately two and one-half hours. This will include performing Cardiopulmonary exercise testing followed by serial spirometry, measuring exhaled nitric oxide levels, and obtaining blood and sputum samples.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43201
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Forty patients with cystic fibrosis and mild lung disease (defined by FEV1≥ 70% predicted), age 12 years and older, are our target enrollments.

Description

Inclusion Criteria:

1. Males and females with confirmed diagnosis of Cystic Fibrosis:

   • 2 positive sweat chloride tests (or)
   • genetic testing
2. Age 12 years and older
3. Baseline FEV1 ≥70% predicted

4. Clinically stable over past 28 days:

   • no change in chronic respiratory symptoms
   • no need for antibiotics other then chronic maintenance therapies
   • no need for oral steroids
   • no increased use of bronchodilators
5. Visit 1 FEV1 within 10% of baseline

Exclusion Criteria:

1. History of Allergic Bronchopulmonary Aspergillosis (ABPA)
2. Chronic airway colonization with Burkholderia cepacia (defined as 2 or more prior positive sputum or BAL cultures)
3. Pregnancy
4. Chronic oral corticosteroid use
5. Febrile illness within two weeks of Visit 1
6. Unable to provide consent (patients under age of 18 will require both parental consent AND patient assent)
7. Current cigarette smoking, cessation of smoking within 6 weeks of Visit 1, or more than 10 pack-years of prior smoking

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the prevalence of exercise-induced bronchospasm in a cohort of adolescent and adult patients with cystic fibrosis	end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the prevalence of exercise-induced bronchospasm in those CF patients with evidence of allergic inflammation versus those without allergic inflammation.	end of study
To determine the difference in exhaled nitric oxide and other surrogate markers of inflammation, as well as self-reported quality-of-life and symptom scores in CF patients with and without exercise-induced bronchospasm.	end of study

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: John G. Mastronarde, MD, Ohio State University

Publications and helpful links

General Publications

• Kirkby SE, Hayes D Jr, Parsons JP, Wisely CE, Kopp B, McCoy KS, Mastronarde JG. Eucapnic Voluntary Hyperventilation to Detect Exercise-Induced Bronchoconstriction in Cystic Fibrosis. Lung. 2015 Oct;193(5):733-8. doi: 10.1007/s00408-015-9745-3. Epub 2015 Jun 3.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (ESTIMATE): December 10, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 19, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: to determine how often exercise-induced bronchospasm; occurs in cystic fibrosis; Exercise-induced bronchospasm in cystic fibrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Infant, Newborn, Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Respiratory Hypersensitivity; Hypersensitivity; Pancreatic Diseases; Asthma; Fibrosis; Cystic Fibrosis; Bronchial Spasm; Asthma, Exercise-Induced
• Other Study ID Numbers: 2007H0319