Exercise-Induced Bronchospasm in Cystic Fibrosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00806455

Enrollment

Registered

2008-12-10

Start date

2008-07-31

Completion date

2013-08-31

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchospasm, Cystic Fibrosis

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results