Evaluation of Halotherapy as Asthma Treatment in Children (NCT02772341) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Halotherapy as Asthma Treatment in Children
60 participantsStarted 2012-08
Plain-language 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.
Who can participate
Age range
5 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Provocative concentration causing a 20% fall in the forced expiratory volume at one second (PC20-FEV1) as assessed by Methacholine Challenge Test