Exercise-Induced Bronchospasm in Cystic Fibrosis

Completed

• Conditions: Cystic Fibrosis; Bronchospasm

• Registration Number: NCT00806455
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States