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Adelmidrol to fight upper airways inflammation in children: a pilot case control study to safety and efficacy
Antonio Della Volpe1, Chiara Bruno1, Pietro De Luca2
1Otolaryngology Department, Santobono-Posillipon Hospital, Via Mario Fiore 6, 80129, Naples, Italy.
Insights
Adelmidrol spray effectively treats upper respiratory tract (URT) inflammation in children. Combining nasal and oral Adelmidrol sprays showed superior results compared to standard treatments, offering a potentially safer alternative.
Area of Science:
- Pediatric Otolaryngology
- Pharmacology
- Inflammation Research
Background:
- Upper respiratory tract (URT) inflammations are prevalent in children, often managed with mucolytics and steroids.
- Steroid treatments for pediatric URT inflammation carry risks, such as altered smell, necessitating safer alternatives.
- Adelmidrol is explored as a potential therapeutic agent for pediatric URT inflammation due to its safety profile.
Purpose of the Study:
- To evaluate the efficacy of Adelmidrol in treating upper respiratory tract (URT) inflammation in children.
- To compare Adelmidrol's effectiveness against standard mucolytic and steroid treatments.
- To assess Adelmidrol's safety and adverse effect profile in pediatric patients.
Main Methods:
- A case-control study involving 60 children aged 2.5-4.5 years with URT inflammation.
- Participants were randomized into a control group (standard treatment) and two Adelmidrol treatment groups (nasal spray only, or nasal and oral spray).
- Evaluations of URT and tympanic membrane were conducted at baseline, 30 days, and 90 days, with 90 consecutive days of treatment.
Main Results:
- The group receiving both nasal and oral Adelmidrol sprays demonstrated significantly better outcomes for URT findings (p=0.0004) and tympanic membrane conditions (p=0.03).
- Adelmidrol nasal spray alone showed comparable efficacy to the standard treatment group.
- No adverse effects were reported for Adelmidrol treatment groups.
Conclusions:
- Adelmidrol demonstrates comparable efficacy to standard treatments when administered as a nasal spray for pediatric URT inflammation.
- A combination of nasal and oral Adelmidrol sprays appears more effective than standard treatments.
- Adelmidrol presents a promising alternative to traditional therapies for pediatric URT inflammation, potentially offering similar benefits without adverse effects.
Purpose:
Inflammations of the upper respiratory tract (URT) are common both in adults and children and they are generally treated using aerosol therapy with mucolytic medications and steroids. When these inflammations affect children, the treatment must be rapid and resolutive to prevent complications. Steroids present some contraindications, i.e. alteration of smell, that must be considered especially in children. Therefore, alternative treatments that have similar efficacy but limited adverse effects should be considered. This study aims at evaluating the efficacy of Adelmidrol to treat inflammation of the URT in children.
Methods:
Case-Control study. Control group used standard treatment for URT inflammation (mucolytics and steroids); treatment groups were treated by Adelmidrol spray. Sixty children (age range 2.5-4.5 years) were randomly assigned to (i) control group, (ii) treatment group 1 (TG1)- Adelmidrol nasal spray only and (iii) treatment group 2 (TG2), in which Adelmidrol was administered in both nasal and oral spray solution. The URT and the tympanic membrane were evaluated at T0, T1 (30 days) and T2 (90 days). The treatments were performed for 90 consecutive days.
Results:
At the end of the treatment, TG2 (combination of nasal and oral sprays) had the best outcomes both on URT findings (χ²: p = 0.0004) and tympanic membrane conditions (χ²: p = 0.03). TG1 showed similar outcome of CG.
Conclusions:
These preliminary results in our group of 60 children showed that Adelmidrol had the same efficacy of standard treatment when used as nasal spray only and was better than the standard treatment when used combining nasal and oral sprays. The molecule seems to offer the same benefit of standard treatment without side effects. If confirmed on a larger sample, the use of Adelmidrol could be suggested as an alternative to traditional treatment for the inflammation of URT in children.
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