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A Clinical Trial of Home Lung Function and Symptom Monitoring in Cystic Fibrosis (CF)

2014-08-27 03:14:33 | BioPortfolio

Summary

Cystic fibrosis (CF) is the most common life shortening inherited disease in Caucasians. Individuals with CF develop chronic lung infections and suffer intermittent acute exacerbations of their lung disease, which require intensive treatment with antibiotics. The most common objective measure of CF lung disease is spirometry, which is measured during physician visits. Early, aggressive treatment of lung disease improves outcomes, but most exacerbations are not treated until they cause increased symptoms, and patients seek medical attention. Another obstacle to CF care is poor adherence to therapy. Individuals with CF frequently take more than eight different medications, many of which are costly and difficult to administer. Self-monitoring of clinical status has improved outcomes in many other disorders such as asthma and diabetes mellitus, but has not been widely studied in CF. 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 daily; or 2) CF education. The home monitoring data will be transmitted via phone modem 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. Subjects in the CF Education arm will contact the study nurse if they become symptomatic of an exacerbation. 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.

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. Another obstacle to CF care is poor adherence to therapy. Individuals with CF frequently take as many as eight different medications, many of which are difficult to administer and costly. Self-monitoring of clinical status has improved outcomes in many other disorders such as asthma, diabetes mellitus, and lung transplantation. This proposal details an important, randomized trial of home lung function and symptom monitoring. Subjects will be assigned to one of two groups: 1) home monitoring, in which spirometry and symptoms are recorded daily; or 2) CF education. The home monitoring data will be transmitted electronically 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 two main hypotheses: 1) home FEV1 and symptom monitoring will result in better lung function, and 2) home monitoring will improve medication adherence.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

Home lung function and symptom monitoring

Location

Johns Hopkins University CF Clinic
Baltimore
Maryland
United States
21205

Status

Not yet recruiting

Source

Johns Hopkins University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:33-0400

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