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Early Intervention in Cystic Fibrosis Exacerbation (eICE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104402
First Posted: April 15, 2010
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Washington
National Institutes of Health (NIH)
Cystic Fibrosis Foundation Therapeutics
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention
Cystic Fibrosis Device: Home lung function and symptom monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Intervention in Cystic Fibrosis Exacerbation

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 267
Study Start Date: October 2011
Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Johns Hopkins University
University of Washington
National Institutes of Health (NIH)
Cystic Fibrosis Foundation Therapeutics
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Noah Lechtzin, MD Johns Hopkins University
Principal Investigator: Christopher Goss, MD University of Washington
  More Information

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 Submitted: April 12, 2010
First Posted: April 15, 2010
Results First Submitted: July 19, 2017
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