Evaluation of Halotherapy as Asthma Treatment in Children

Evaluation of Halotherapy as Asthma Treatment in Children: a Randomized, Controlled, Double-blind Prospective Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Salt room with halogenerator; Other: Salt room without 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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Salt room with halogenerator; Asthmatic patients sitting in a salt room with salt aerosol produced by a halogenerator.	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 Names: Treatment
Placebo Comparator: Salt room without halogenerator; Asthmatic patients sitting in a salt room without salt aerosol	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 Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Provocative concentration causing a 20% fall in the forced expiratory volume at one second (PC20-FEV1) as assessed by Methacholine Challenge Test	Study visit 1,2 (7 wks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of exhaled Nitric Oxide in exhaled breath	Fractional Exhaled NO	Study visit study 1,2 (7 wks)
Pulmonary function as assessed by spirometry	Spirometry	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)		Study visit study 1,2 (7 wks)

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Lea Bentur, Prof., Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: April 10, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 13, 2016

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Asthma; Halotherapy; Airway hyper-reactivity; Metacholine
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 0059-12- RMB-CTIL