Abstract

Can asthma be controlled in children without using chemical drugs? Preliminary clinical results with a protective & nasal surface cleaning polymeric osmotic film

Author(s): Remi Shrivastava, Megha Vijay, Sayali Sadgune, Ankit Samadhiya

Background: Asthma is a multifactorial, immunological disease, having a complex physiopathology involving the contact between asthma
triggering factors and the nasal mucosa, nasal mucosa damage, release of disease-specific TSLP and other proinflammatory cytokines
such as IL-5, 6, 25, 33, responsible for persistent Upper Respiratory Tract (URT) inflammation. An effective treatment must prevent asthma
trigger and should be multitarget, but all current treatments are either chemicals, mono-target, or symptomatic and are not adapted
for long-term use in children. We evaluated the efficacy and safety of an osmotically active, stable, non-irritant, and totally safe nasal
surface film to simultaneously protect, clean, remove inflammatory cytokines, reduce nasal mucosa inflammation and reconstitute the
natural defensive barrier of the nasal mucosa, to minimize the intensity, frequency, and duration of asthma exacerbations as a preventive
measure.

Methods: We conceived a glycerol-based, polymeric, stable, osmotic solution for topical application on the nasal surface. The filmogen
solution was filled in 15-ml nasal sprays (Asmidine®, 125 μl/spray t.i.d.) and its preventive efficacy and clinical safety wer e com pared to
Salbutamol (100 μg/dose, 1-2 oral puffs, t.i.d.) during an 84-day clinical trial including 12 children in Asmidine group and 11 in Salbutamol
group, aged 8 years-18 years old, conducted as per GINA recommendations. The trial was approved by the Ethics Committee and was
registered under n°: CTRI/2021/06/034142 (http://ctri.nic.in) by Mudra Clincare, Mumbai, India.

Findings: Both test products markedly increased Peak Expiratory Flow rate (PEFR) and forced Expiratory volume (FEV1), controlled
Bronchial Asthma (BA), improved quality of life of children, reduced the need for SABA and minimized the frequency of asthma
exacerbations, without any drug-related adverse effects. The efficacy of Asmidine® was progressive and only slightly lower compared to
Salbutamol.

Conclusion: Asmidine®, registered as a new generation of asthma prevention medical device in Europe, is the 1st multitarget, safe, and
effective asthma treatment alternative to chemical drugs