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Evaluation of Halotherapy as Asthma Treatment in Children

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Sodium

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




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) ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772341


Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Lea Bentur, Prof. Rambam Health Care Campus
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02772341    
Other Study ID Numbers: 0059-12- RMB-CTIL
First Posted: May 13, 2016    Key Record Dates
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:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases