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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 23 May 2016
Main ID:  NCT02772341
Date of registration: 10/04/2016
Prospective Registration: No
Primary sponsor: Rambam Health Care Campus
Public title: Evaluation of Halotherapy as Asthma Treatment in Children
Scientific title: Evaluation of Halotherapy as Asthma Treatment in Children: a Randomized, Controlled, Double-blind Prospective Pilot Study
Date of first enrolment: August 2012
Target sample size: 60
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02772341
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)  
Phase:  N/A
Countries of recruitment
Contacts
Name:   Lea Bentur, Prof.
Address: 
Telephone:
Email:
Affiliation:  Rambam Health Care Campus
Key inclusion & exclusion criteria

Inclusion Criteria:

- 5-13 years

- Mild asthma

- Positive methacholine challenge test (MCV, PC20-FEV1 <16mg/ml)

Exclusion Criteria:

- Any Chronic Lung Disease

- Febrile Illness in last 2 weeks

- FEV1 < 65% in study day

- Bronchodilators over the past 24 hours prior to each study

- Participation in any other clinical studies over the past 4 weeks

- Any acute illness on the day of the MCT,

- Anti-inflammatory treatment (inhaled corticosteroids or montelukast) over the
previous two weeks before the MCT).

- Systemic corticosteroids in the two months prior to enrollment

- Emergency room (ER) visit or hospital admission following a respiratory illness
during the 2-month period prior to enrollment.

- Previous halotherapy treatment.



Age minimum: 5 Years
Age maximum: 13 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Asthma
Intervention(s)
Device: Salt room with halogenerator
Other: Salt room without halogenerator
Primary Outcome(s)
Provocative concentration causing a 20% fall in the forced expiratory volume at one second (PC20-FEV1) as assessed by Methacholine Challenge Test [Time Frame: Study visit 1,2 (7 wks)]
Secondary Outcome(s)
Determination of exhaled Nitric Oxide in exhaled breath [Time Frame: Study visit study 1,2 (7 wks)]
Pulmonary function as assessed by spirometry [Time Frame: Study visit study 1,2 (7 wks)]
Quality of life of childhood asthma as assessed by the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ) [Time Frame: Study visit study 1,2 (7 wks)]
Secondary ID(s)
0059-12- RMB-CTIL
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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