Evaluation of Halotherapy as Asthma Treatment in Children

NCT02772341 | Completed

• 1 other identifier: 0059-12- RMB-CTIL
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Asthma; Halotherapy; Airway hyper-reactivity; Metacholine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Determination of exhaled Nitric Oxide in exhaled breath

  Study visit study 1,2 (7 wks)

• Pulmonary function as assessed by 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)

Study Arms (2)

Salt room with halogenerator

ACTIVE COMPARATOR

Asthmatic patients sitting in a salt room with salt aerosol produced by a halogenerator.

Device: Salt room with halogenerator

Salt room without halogenerator

PLACEBO COMPARATOR

Asthmatic patients sitting in a salt room without salt aerosol

Other: Salt room without halogenerator

Interventions

Salt room with halogenerator DEVICE

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.

Also known as: Treatment

Salt room with halogenerator

Salt room without halogenerator OTHER

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.

Also known as: Placebo

Salt room without halogenerator

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years
• Mild asthma
• Positive methacholine challenge test (MCV, PC20-FEV1 \<16mg/ml)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Asthma

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lea Bentur, Prof.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: May 13, 2016
• Study Start: August 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: February 1, 2015
• Last Updated: May 13, 2016

Record last verified: 2016-05