Early Intervention in Cystic Fibrosis Exacerbation (eICE)
|ClinicalTrials.gov Identifier: NCT01104402|
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : October 23, 2017
Last Update Posted : October 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: Home lung function and symptom monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Intervention in Cystic Fibrosis Exacerbation|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||September 2015|
No Intervention: Standard Care
Subjects will receive education about signs and symptoms indicative of worsening CF.
Active Comparator: Home monitoring
Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.
Device: Home lung function and symptom monitoring
subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device.
Other Name: Jaeger AM2 monitor
- Change in FEV1 [ Time Frame: 12 months ]The primary outcome variable is FEV1 which will be obtained at quarterly study visits. The primary analysis will use a linear mixed effects model incorporating all FEV1 measurements to estimate the 52-week change in FEV1
- Cystic Fibrosis Respiratory Symptom Diary (CFRSD) [ Time Frame: 12 months ]Change in CF respiratory symptoms as measured by the CFRSD. The CFRSD consists of 8 items which quantify symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recovery from an exacerbation. The CFRSD also includes emotional and activity impacts. Emotional impacts include frustration, sadness/depression, irritability, worry, and difficulty sleeping. Activity impacts include time spent sitting or lying down, reduction of usual activities, and missing school or work. will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. The range of scores is 8 to 40 with higher scores indicating more severe symptoms.
- Pulmonary Exacerbations [ Time Frame: 12 months ]Percentage of participants who experienced at least one acute pulmonary exacerbation
- Change in Health Related Quality of Life Scores as Assessed by the Cystic Fibrosis Questionnaire Revised (CFQ-R) (Respiratory Subscale Only( [ Time Frame: Change from baseline to 12 months ]Change in health related quality of life as measured by the Cystic Fibrosis Questionnaire revised (CFQ-R)will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. The CFQ-R measures functioning in a variety of domains, including Physical Functioning, Vitality, Health Perceptions, Respiratory Symptoms, Treatment Burden, Role Functioning, Emotional Functioning, and Social Functioning. Only the respiratory subscale of the the CFQ-R was evaluated. This ranges from 0 to 100 with higher scores indicating better respiratory quality of life. A negative number indicates a decrease in respiratory quality of life.
- Treatment Burden [ Time Frame: Change from baseline to 12 months ]Change in treatment burden as measured by the Cystic Fibrosis Questionnaire revised (CFQ-R)will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. Scores range from 0-100 with higher scores indicating less treatment burden.
- Change in Prevalence of Resistant Species of Bacteria [ Time Frame: 12 months ]Change in prevalence of resistant species of bacteria (Methicillin Resistant S. aureus, Pseudomonas aeruginosa, Burkolderia cepacia, Stenotrophomona maltophilia, Achromobacterxylosoxidans) in sputum between baseline and final visit (Visit 5 or early withdrawal) will be summarized by treatment group.
- Serious Adverse Events (SAE) [ Time Frame: 12 months ]Adverse event rates will be coded by body system and MedDRA classification term. Adverse events will be tabulated by treatment group and will include the number of subjects for whom the event occurred, the rate of occurrence, and the severity and relationship to study participation or study procedures.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104402
|United States, Maryland|
|Johns Hopkins University CF Clinic|
|Baltimore, Maryland, United States, 21205|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98104-2499|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105-5371|
|Principal Investigator:||Noah Lechtzin, MD||Johns Hopkins University|
|Principal Investigator:||Christopher Goss, MD||University of Washington|