Exercise-Induced Bronchospasm in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Mastronarde, MD, Ohio State University
ClinicalTrials.gov Identifier:
NCT00806455
First received: December 9, 2008
Last updated: November 18, 2013
Last verified: November 2013
  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:


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


Enrollment: 14
Study Start Date: July 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43201
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: John G. Mastronarde, MD Ohio State University
  More Information

No publications provided

Responsible Party: John Mastronarde, MD, John Mastronard M.D., Ohio State University
ClinicalTrials.gov Identifier: NCT00806455     History of Changes
Other Study ID Numbers: 2007H0319
Study First Received: December 9, 2008
Last Updated: November 18, 2013
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:
Cystic Fibrosis
Bronchial Spasm
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 July 29, 2014