Exercise-Induced Bronchospasm in Cystic Fibrosis

NCT00806455 | Completed

• 1 other identifier: 2007H0319
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Bronchospasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To determine the prevalence of exercise-induced bronchospasm in a cohort of adolescent and adult patients with cystic fibrosis

  end of study

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Males and females with confirmed diagnosis of Cystic Fibrosis:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43201, United States

Location

Related Publications (1)

• Kirkby SE, Hayes D Jr, Parsons JP, Wisely CE, Kopp B, McCoy KS, Mastronarde JG. Eucapnic Voluntary Hyperventilation to Detect Exercise-Induced Bronchoconstriction in Cystic Fibrosis. Lung. 2015 Oct;193(5):733-8. doi: 10.1007/s00408-015-9745-3. Epub 2015 Jun 3.

  PMID: 26036953 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, sputum

MeSH Terms

Conditions

Cystic Fibrosis; Bronchial Spasm

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases

Study Officials

• John G. Mastronarde, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John Mastronard M.D.

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

US (1)