Early Intervention in Cystic Fibrosis Exacerbation (eICE)
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ClinicalTrials.gov Identifier: NCT01104402 |
Recruitment Status
:
Completed
First Posted
: April 15, 2010
Results First Posted
: October 23, 2017
Last Update Posted
: October 23, 2017
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Condition or disease | Intervention/treatment | Phase |
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Cystic Fibrosis | Device: Home lung function and symptom monitoring | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 267 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
No Intervention: Standard Care
Subjects will receive education about signs and symptoms indicative of worsening CF.
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Active Comparator: Home monitoring
Subjects will be randomized to monitor home spirometry and symptoms using a handheld device.
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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
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- 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.

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Ages Eligible for Study: | 14 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01104402 History of Changes |
Other Study ID Numbers: |
NL001 LECHTZ10A0 ( Other Grant/Funding Number: Cystic Fibrosis Foundation ) R01HL103965 ( U.S. NIH Grant/Contract ) |
First Posted: | April 15, 2010 Key Record Dates |
Results First Posted: | October 23, 2017 |
Last Update Posted: | October 23, 2017 |
Last Verified: | September 2017 |
Keywords provided by Johns Hopkins University:
telemedicine spirometer CF pulmonary home monitoring |
Additional relevant MeSH terms:
Fibrosis Cystic Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |