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Hypertonic Saline and Mucociliary Clearance in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293084
First Posted: February 10, 2011
Last Update Posted: September 22, 2015
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.
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Beth L. Laube, Johns Hopkins University
Results First Submitted: September 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Interventions: Drug: 0.12% saline
Drug: 7% saline

  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
Data could not be retrieved for the order of randomization.

Reporting Groups
  Description
Children With CF Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.

Participant Flow:   Overall Study
    Children With CF
STARTED   17 
COMPLETED   12 
NOT COMPLETED   5 
Physician Decision                3 
Withdrawal by Subject                2 



  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
Children With CF Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.

Baseline Measures
   Children With CF 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 10.5 
 (8.9 to 12.4) 
Gender 
[Units: Participants]
 
Female   7 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   12 
FVC (% predicted) 
[Units: Percent predicted]
Median (Inter-Quartile Range)
 107 
 (101.5 to 116.0) 
FEV1 (% predicted) 
[Units: Percent predicted]
Median (Inter-Quartile Range)
 108 
 (102.5 to 117.5) 
Genotype 
[Units: Participants]
 
F508del homozygous   9 
F508heterozygous   2 
Other   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Mucociliary Clearance at 60 Minutes   [ Time Frame: 60 minutes ]

2.  Secondary:   Percent Mucociliary Clearance at 90 Minutes   [ Time Frame: 90 minutes ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Beth Laube Professor
Organization: Johns Hopkins Univeristy
phone: 410-502-5791
e-mail: blaube@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Beth L. Laube, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01293084     History of Changes
Other Study ID Numbers: CFF Account #LAUBE06A0
First Submitted: February 9, 2011
First Posted: February 10, 2011
Results First Submitted: September 10, 2015
Results First Posted: September 22, 2015
Last Update Posted: September 22, 2015