Exercise-Induced Bronchospasm in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Exercise-Induced Bronchospasm in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806455
• Other study ID #: 2007H0319
• Status: Completed
• Phase: N/A
• First received: December 9, 2008
• Last updated: November 18, 2013
• Start date: July 2008
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma, Exercise-Induced
• Bronchial Spasm
• Bronchospasm
• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the prevalence of exercise-induced bronchospasm in a cohort of adolescent and adult patients with cystic fibrosis		end of study	No
Secondary	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	No
Secondary	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	No