Hypertonic Saline and Mucociliary Clearance in Children

This study has been completed.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Beth L. Laube, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01293084
First received: February 9, 2011
Last updated: September 10, 2015
Last verified: September 2015
Results First Received: September 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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
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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
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  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
Study First Received: February 9, 2011
Results First Received: September 10, 2015
Last Updated: September 10, 2015
Health Authority: United States: Food and Drug Administration