Clinical trial NCT02772341: Evaluation of Halotherapy as Asthma Treatment in Children
Official title: Evaluation of Halotherapy as Asthma Treatment in Children: a Randomized, Controlled, Double-blind Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Halotherapy
Airway hyper-reactivity
Metacholine
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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.

Primary outcomes:
measure: Provocative concentration causing a 20% fall in the forced expiratory volume at one second (PC20-FEV1) as assessed by Methacholine Challenge Test
timeFrame: Study visit 1,2 (7 wks)
Secondary outcomes:
measure: Determination of exhaled Nitric Oxide in exhaled breath
timeFrame: Study visit study 1,2 (7 wks)
measure: Pulmonary function as assessed by spirometry
timeFrame: Study visit study 1,2 (7 wks)
measure: Quality of life of childhood asthma as assessed by the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
timeFrame: Study visit study 1,2 (7 wks)
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Lea Bentur, Prof.
role: PRINCIPAL_INVESTIGATOR
References: