Exercise-Induced Bronchospasm in Cystic Fibrosis

NCT ID: NCT00806455

Last Updated: 2013-11-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-08-31

Brief Summary

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.

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.

Conditions

Cystic Fibrosis; Bronchospasm

Keywords

to determine how often exercise-induced bronchospasm; occurs in cystic fibrosis; Exercise-induced bronchospasm in cystic fibrosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

John Mastronarde, MD

John Mastronard M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John G. Mastronarde, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26036953 (View on PubMed)

Other Identifiers

2007H0319

Identifier Type: -

Identifier Source: org_study_id