Evaluation of Halotherapy as Asthma Treatment in Children

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Device: Salt room with halogenerator; Other: Salt room without halogenerator	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Official Title: Evaluation of Halotherapy as Asthma Treatment in Children: a Randomized, Controlled, Double-blind Prospective Pilot Study
• Study Start Date: August 2012
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: February 2015

Arms and Interventions

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 Name: 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 Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Determination of exhaled Nitric Oxide in exhaled breath [ Time Frame: Study visit study 1,2 (7 wks) ]
   Fractional Exhaled NO
2. Pulmonary function as assessed by spirometry [ Time Frame: Study visit study 1,2 (7 wks) ]
   Spirometry
3. 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) ]

Eligibility Criteria

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

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.

Contacts and Locations

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

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

More Information

• Responsible Party: Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT02772341
• Other Study ID Numbers: 0059-12- RMB-CTIL
• First Posted: May 13, 2016
• Last Update Posted: May 13, 2016
• Last Verified: May 2016

Keywords provided by Rambam Health Care Campus:

Asthma; Halotherapy; Airway hyper-reactivity; Metacholine

Additional relevant MeSH terms:

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