Evaluation of Halotherapy as Asthma Treatment in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

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.
    

Intervention name(s): Salt room with halogenerator; Salt room without halogenerator
Intervention type(s): Device; Other
Intervention description(s): 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.; 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 intervention name(s): Treatment; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Asthma; Halotherapy; Airway hyper-reactivity; Metacholine