Exercise-Induced Bronchospasm in Cystic Fibrosis - Full Text View

Sponsor:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00806455

Purpose

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.

Condition
Cystic Fibrosis Bronchospasm

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Exercise-Induced Bronchospasm in Cystic Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Asthma Cystic Fibrosis Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:

To determine the prevalence of exercise-induced bronchospasm in a cohort of adolescent and adult patients with cystic fibrosis [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the prevalence of exercise-induced bronchospasm in those CF patients with evidence of allergic inflammation versus those without allergic inflammation. [ Time Frame: end of study ] [ Designated as safety issue: No ]
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. [ Time Frame: end of study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

blood, sputum

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria:

Males and females with confirmed diagnosis of Cystic Fibrosis:
- 2 positive sweat chloride tests (or)
- genetic testing
Age 12 years and older
Baseline FEV1 ≥70% predicted
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
Visit 1 FEV1 within 10% of baseline

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806455

Contacts

Contact: Janice E. Drake, CRRT	614-247-7707	john.mastronarde@osumc.edu
Contact: Sharon Cheung, BS	614-366-2258	sharon.cheung@osumc.edu

Locations

United States, Ohio
The Ohio State University	Recruiting
Columbus, Ohio, United States, 43201
Contact: Janice E Drake, MD 614-366-2287 janice.drake@osumc.edu
Contact: Sharon Cheung, BS 614-366-2258 sharon.cheung@osumc.edu
Sub-Investigator: Stephen Kirkby, MD

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator:

John G. Mastronarde, MD

Ohio State University

More Information

No publications provided

Responsible Party:	John G. Mastronarde, M.D. Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier:	NCT00806455 History of Changes
Other Study ID Numbers:	2007H0319
Study First Received:	December 9, 2008
Last Updated:	August 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

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

Additional relevant MeSH terms:

Bronchial Spasm
Cystic Fibrosis
Asthma, Exercise-Induced
Fibrosis
Bronchial Diseases
Respiratory Tract Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases

Genetic Diseases, Inborn
Infant, Newborn, Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012