Early Intervention in Cystic Fibrosis Exacerbation (eICE)

Johns Hopkins University

Status

Completed

Conditions

Cystic Fibrosis

Treatments

Device: Home lung function and symptom monitoring

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01104402

R01HL103965 (U.S. NIH Grant/Contract)

NL001

LECHTZ10A0 (Other Grant/Funding Number)

Details and patient eligibility

About

Individuals with cystic fibrosis (CF) develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease. Most exacerbations are not treated until they cause increased symptoms, and patients seek medical attention. This proposal details a study of home lung function and symptom monitoring. Subjects will be randomly assigned to one of two groups: 1) home monitoring, in which spirometry and symptoms are recorded; or 2) standard care. The home monitoring data will be transmitted electronically to the study center. If spirometry or symptoms have deteriorated substantially, treatment for a CF pulmonary exacerbation will be initiated. It is anticipated that use of home monitoring will lead to earlier, more reliable recognition and treatment of exacerbations, which will translate into better lung health.

Full description

Individuals with CF develop chronic lung infections and suffer intermittent exacerbations, which require intensive treatment with antibiotics. The most common and useful objective measure of CF lung disease is spirometry. Chronic treatment of CF lung disease requires airway clearance, mucolytics and antibiotics. These treatments have been quite successful and there is evidence that early, aggressive treatment of lung disease results in better outcomes. Unfortunately, most exacerbations are not treated until they cause pronounced deterioration in symptoms, which prompts patients to seek medical attention. Self-monitoring of clinical status has improved outcomes in many other disorders such as asthma, diabetes mellitus, and lung transplantation. This is an important, randomized trial of home lung function and symptom monitoring in CF. Subjects will be assigned to one of two groups: 1) Home monitoring, in which spirometry and symptoms are recorded daily; or 2) Standard Care. The home monitoring data will be transmitted electronically twice weekly to the study center, where the results will be reviewed. If spirometry or symptoms have deteriorated substantially below baseline, treatment for a CF pulmonary exacerbation will be initiated. It is anticipated that use of home monitoring will translate into better clinical outcomes. We will test the hypothesis that if pulmonary exacerbations are identified and treated earlier than the current standard of care, the progression of lung disease will be slowed.

Enrollment

267 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

CF diagnosis confirmed with sweat test, abnormal nasal potential difference and/or genetic testing
Age 14 and older
Able to perform spirometry
Clinically stable without antibiotic treatment for a pulmonary exacerbation in the two weeks prior to the screening visit
Forced expiratory volume in the first second (FEV1) greater than 25% of predicted at screening

Exclusion criteria

History of solid organ transplant
Participation in any interventional trial within the last 30 days
Inability to speak and read the English language well enough to complete questionnaires
Colonization with Burkholderia cepacia genomovar III within the last 24 months
Currently receiving antimicrobial treatment specifically used to treat active non-tuberculosis mycobacterium
Confirmed diagnosis of allergic bronchopulmonary aspergillosis (ABPA) as defined by the Cystic Fibrosis Foundation (CFF) guidance document that is being actively treated