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Evaluation of Halotherapy as Asthma Treatment in Children

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ClinicalTrials.gov Identifier: NCT02772341
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Tracking Information
First Submitted Date  ICMJE April 10, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE August 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
  • Determination of exhaled Nitric Oxide in exhaled breath [ Time Frame: Study visit study 1,2 (7 wks) ]
    Fractional Exhaled NO
  • Pulmonary function as assessed by spirometry [ Time Frame: Study visit study 1,2 (7 wks) ]
    Spirometry
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Halotherapy as Asthma Treatment in Children
Official Title  ICMJE Evaluation of Halotherapy as Asthma Treatment in Children: a Randomized, Controlled, Double-blind Prospective Pilot Study
Brief Summary

Background: Asthma is a chronic inflammatory disorder requiring intermittent or continuous anti-inflammatory therapy. Patients often turn to alternative treatments as complements or replacements to conventional treatments.

Aim: To evaluate the effect of salt room chambers (halotherapy) on bronchial hyper- responsiveness (BHR), fractional exhaled nitric oxide (FeNO), and quality of life in children with asthma.

Patients: Children aged 5-13 years with a clinical diagnosis of mild asthma not receiving anti-inflammatory therapy.

Methods: Randomized, double-blind, placebo-controlled study assessing the effect of salt room therapy on BHR, FeNO, spirometry and pediatric asthma quality of life questionnaire (PAQLQ). The treatment period lasted 7 weeks, 14 sessions with (treatment group) or without salt halogenerator.

Detailed Description

Asthma is a chronic inflammatory disorder requiring intermittent or continuous anti-inflammatory therapy. Patients often turn to alternative treatments as complements or replacements to conventional treatments.

Our aim: To evaluate the effect of salt room chambers (halotherapy) on bronchial hyper - responsiveness (BHR), fractional exhaled nitric oxide (FeNO), and quality of life in children with asthma.

Patients: Children aged 5-13 years with a clinical diagnosis of mild asthma not receiving anti-inflammatory therapy.

Methods: Randomized, double-blind, placebo-controlled study assessing the effect of salt room therapy on BHR, FeNO, spirometry and pediatric asthma quality of life questionnaire (PAQLQ). The treatment period lasted 7 weeks, 14 sessions with (treatment group) or without salt halogenerator.

Visit 1: Written parental consent. Demographics, child's asthma/atopy history, and family history of asthma/atopy/smoking. The Pediatric asthma quality of life questionnaire (PAQLQ) by the patient/caregiver and the interviewer. Each patient performed spirometry, methacholine challenge test (MCT) and FeNO measurements. Following a positive MCT, patients were randomized to 14 sessions (7 weeks, twice weekly, 45 minutes each treatment) sitting in a salt room with salt aerosol produced by a halogenerator (study group) or halotherapy without salt aerosol (placebo). Both the walls and the ceiling of the salt room are completely covered with European Salt Company (ESCO) type certified-origin rock salt. The temperature (20-24°C) and humidity (44-60%) are at constant values. The halogenerator is located outside the salt room.

In the study group, dry sodium chloride (NaCl) particles (~20μm) were blown into the salt room while the blower was working without NaCl in the placebo group. The patients could not tell if dry salt aerosol was generated by halogenerator or not. The patients were instructed to use inhaled β2beta agonists as needed and to report any asthma exacerbation, use of medication or health care visit.

Visit 2: After seven weeks, each patient was re-evaluated by spirometry, MCT, FeNO, and PAQLQ.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Condition  ICMJE Asthma
Intervention  ICMJE
  • Device: Salt room with halogenerator
    Patients were assigned to 14 sessions (7 weeks, twice weekly, 45 minutes each treatment) sitting in a salt room with salt aerosol produced by a halogenerator (study group) or halotherapy without salt aerosol (placebo). Both the walls and the ceiling of the salt room are completely covered with ESCO-(European Salt Company) type certified-origin rock salt. The temperature (20-24°C) and humidity (44-60%) are at constant values. The halogenerator is located outside the salt room.
    Other Name: Treatment
  • Other: Salt room without halogenerator
    Patients were assigned to 14 sessions (7 weeks, twice weekly, 45 minutes each treatment) sitting in a salt room without salt aerosol (placebo). Both the walls and the ceiling of the salt room are completely covered with ESCO-(European Salt Company) type certified-origin rock salt. The temperature (20-24°C) and humidity (44-60%) are at constant values.
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: Salt room with halogenerator
    Asthmatic patients sitting in a salt room with salt aerosol produced by a halogenerator.
    Intervention: Device: Salt room with halogenerator
  • Placebo Comparator: Salt room without halogenerator
    Asthmatic patients sitting in a salt room without salt aerosol
    Intervention: Other: Salt room without halogenerator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2016)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772341
Other Study ID Numbers  ICMJE 0059-12- RMB-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lea Bentur, Prof. Rambam Health Care Campus
PRS Account Rambam Health Care Campus
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP