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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
Results First Submitted: July 19, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Intervention: Device: Home lung function and symptom monitoring

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard Care Subjects will receive education about signs and symptoms indicative of worsening CF.
Home Monitoring

Subjects will be randomized to monitor home spirometry and symptoms using a handheld 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.


Participant Flow:   Overall Study
    Standard Care   Home Monitoring
STARTED   132   135 
COMPLETED   111   102 
NOT COMPLETED   21   33 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Care Subjects will receive education about signs and symptoms indicative of worsening CF.
Home Monitoring

Subjects will be randomized to monitor home spirometry and symptoms using a handheld 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.

Total Total of all reporting groups

Baseline Measures
   Standard Care   Home Monitoring   Total 
Overall Participants Analyzed 
[Units: Participants]
 132   135   267 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      39  29.5%      38  28.1%      77  28.8% 
Between 18 and 65 years      93  70.5%      97  71.9%      190  71.2% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.8  (12.5)   26.5  (11.5)   27.1  (12.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      68  51.5%      68  50.4%      136  50.9% 
Male      64  48.5%      67  49.6%      131  49.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   132   135   267 


  Outcome Measures
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1.  Primary:   Change in FEV1   [ Time Frame: 12 months ]

2.  Secondary:   Cystic Fibrosis Respiratory Symptom Diary (CFRSD)   [ Time Frame: 12 months ]

3.  Secondary:   Pulmonary Exacerbations   [ Time Frame: 12 months ]

4.  Secondary:   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 ]

5.  Secondary:   Treatment Burden   [ Time Frame: Change from baseline to 12 months ]

6.  Secondary:   Change in Prevalence of Resistant Species of Bacteria   [ Time Frame: 12 months ]

7.  Secondary:   Serious Adverse Events (SAE)   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Noah Lechtzin & Dr. Christopher Goss
Organization: Johns Hopkins University & University of Washington
phone: 410-502-7044
e-mail: nlechtz@jhmi.edu



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