Abstract

Conception and clinical efficacy of a novel polymeric ashtma prevention treatment compared to Salbutamol

Author(s): Dr. Rémi Shrivastava, Dr. Sayali Sadgune, Dr. Vaibhav Joshi, Mr. Ankit Samadhiya, Dr. Ravi Shrivastava

Objectives: Asthma is becoming one of the fastest growing epidemics worldwide, affecting already nearly 9% of the population. This is a multifactorial, immunological disease, with a complex physiopathology involving the contact between asthma-triggering factors and nasal mucosa, nasal mucosa damage, the release of disease-specific TSLP, and other proinflammatory cytokines such as IL-5, 6, 25, 33, responsible for persistent upper respiratory tract inflammation. An effective treatment must prevent asthma triggers and should be multitarget. However, all current treatments are either mono-target, symptomatic, chemical, and/or instant-relief bronchodilators, such as Salbutamol. We aimed to conceive an osmotically active, stable, non-irritant, and safe nasal surface film to simultaneously protect, clean, and 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.
Patients and methods: We rendered a glycerol osmotic solution base filmogen stabilized with specific glycerol binding natural inert polymers. These polymers were further screened to identify inflammatory cytokines with sandwich ELISA. The filmogen solution was filled in 15 ml nasal sprays (Asmidine^®, 125µl/spray t.i.d.) and its preventive efficacy and safety were compared to Salbutamol (100 µg/dose, 1-2 oral puffs, t.i.d.) for 84-days, in 45 comparators and 43 Asmidine^® treated patients, as per the GINA recommendations. The trial was approved by the ethical committee and was registered under n°:CTRI/2021/06/034142 (http://ctri.nic.in) by Mudra Clincare, Mumbai, India.
Results: Both test products markedly increased Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV1), Controlled Bronchial Asthma (BA), improved quality of life of the patients as per the SF-36, 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.
Conclusions: Asmidine^®, registered as a new generation of asthma prevention medical device in Europe, is the 1^st multitarget preventive treatment against asthma and can be used in association with drugs used to treat asthma.