Evaluation of Halotherapy as Asthma Treatment in Children

Rambam Health Care Campus

Status

Completed

Conditions

Asthma

Treatments

Device: Salt room with halogenerator

Other: Salt room without halogenerator

Study type

Interventional

Funder types

Other

Identifiers

NCT02772341

0059-12- RMB-CTIL

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment

60 patients

Sex

All

Ages

5 to 13 years old

Volunteers

No Healthy Volunteers

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.