Cargando…
Investigational Treatments in Phase I and II Clinical Trials: A Systematic Review in Asthma
Inhaled corticosteroids (ICS) remain the mainstay of asthma treatment, along with bronchodilators serving as control agents in combination with ICS or reliever therapy. Although current pharmacological treatments improve symptom control, health status, and the frequency and severity of exacerbations...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9496184/ https://www.ncbi.nlm.nih.gov/pubmed/36140430 http://dx.doi.org/10.3390/biomedicines10092330 |
_version_ | 1784794206389141504 |
---|---|
author | Calzetta, Luigino Aiello, Marina Frizzelli, Annalisa Pistocchini, Elena Ritondo, Beatrice Ludovica Rogliani, Paola Chetta, Alfredo |
author_facet | Calzetta, Luigino Aiello, Marina Frizzelli, Annalisa Pistocchini, Elena Ritondo, Beatrice Ludovica Rogliani, Paola Chetta, Alfredo |
author_sort | Calzetta, Luigino |
collection | PubMed |
description | Inhaled corticosteroids (ICS) remain the mainstay of asthma treatment, along with bronchodilators serving as control agents in combination with ICS or reliever therapy. Although current pharmacological treatments improve symptom control, health status, and the frequency and severity of exacerbations, they do not really change the natural course of asthma, including disease remission. Considering the highly heterogeneous nature of asthma, there is a strong need for innovative medications that selectively target components of the inflammatory cascade. The aim of this review was to systematically assess current investigational agents in Phase I and II randomised controlled trials (RCTs) over the last five years. Sixteen classes of novel therapeutic options were identified from 19 RCTs. Drugs belonging to different classes, such as the anti-interleukin (IL)-4Rα inhibitors, anti-IL-5 monoclonal antibodies (mAbs), anti-IL-17A mAbs, anti-thymic stromal lymphopoietin (TSLP) mAbs, epithelial sodium channel (ENaC) inhibitors, bifunctional M(3) receptor muscarinic antagonists/β(2)-adrenoceptor agonists (MABAs), and anti-Fel d 1 mAbs, were found to be effective in the treatment of asthma, with lung function being the main assessed outcome across the RCTs. Several novel investigational molecules, particularly biologics, seem promising as future disease-modifying agents; nevertheless, further larger studies are required to confirm positive results from Phase I and II RCTs. |
format | Online Article Text |
id | pubmed-9496184 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-94961842022-09-23 Investigational Treatments in Phase I and II Clinical Trials: A Systematic Review in Asthma Calzetta, Luigino Aiello, Marina Frizzelli, Annalisa Pistocchini, Elena Ritondo, Beatrice Ludovica Rogliani, Paola Chetta, Alfredo Biomedicines Systematic Review Inhaled corticosteroids (ICS) remain the mainstay of asthma treatment, along with bronchodilators serving as control agents in combination with ICS or reliever therapy. Although current pharmacological treatments improve symptom control, health status, and the frequency and severity of exacerbations, they do not really change the natural course of asthma, including disease remission. Considering the highly heterogeneous nature of asthma, there is a strong need for innovative medications that selectively target components of the inflammatory cascade. The aim of this review was to systematically assess current investigational agents in Phase I and II randomised controlled trials (RCTs) over the last five years. Sixteen classes of novel therapeutic options were identified from 19 RCTs. Drugs belonging to different classes, such as the anti-interleukin (IL)-4Rα inhibitors, anti-IL-5 monoclonal antibodies (mAbs), anti-IL-17A mAbs, anti-thymic stromal lymphopoietin (TSLP) mAbs, epithelial sodium channel (ENaC) inhibitors, bifunctional M(3) receptor muscarinic antagonists/β(2)-adrenoceptor agonists (MABAs), and anti-Fel d 1 mAbs, were found to be effective in the treatment of asthma, with lung function being the main assessed outcome across the RCTs. Several novel investigational molecules, particularly biologics, seem promising as future disease-modifying agents; nevertheless, further larger studies are required to confirm positive results from Phase I and II RCTs. MDPI 2022-09-19 /pmc/articles/PMC9496184/ /pubmed/36140430 http://dx.doi.org/10.3390/biomedicines10092330 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Systematic Review Calzetta, Luigino Aiello, Marina Frizzelli, Annalisa Pistocchini, Elena Ritondo, Beatrice Ludovica Rogliani, Paola Chetta, Alfredo Investigational Treatments in Phase I and II Clinical Trials: A Systematic Review in Asthma |
title | Investigational Treatments in Phase I and II Clinical Trials: A Systematic Review in Asthma |
title_full | Investigational Treatments in Phase I and II Clinical Trials: A Systematic Review in Asthma |
title_fullStr | Investigational Treatments in Phase I and II Clinical Trials: A Systematic Review in Asthma |
title_full_unstemmed | Investigational Treatments in Phase I and II Clinical Trials: A Systematic Review in Asthma |
title_short | Investigational Treatments in Phase I and II Clinical Trials: A Systematic Review in Asthma |
title_sort | investigational treatments in phase i and ii clinical trials: a systematic review in asthma |
topic | Systematic Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9496184/ https://www.ncbi.nlm.nih.gov/pubmed/36140430 http://dx.doi.org/10.3390/biomedicines10092330 |
work_keys_str_mv | AT calzettaluigino investigationaltreatmentsinphaseiandiiclinicaltrialsasystematicreviewinasthma AT aiellomarina investigationaltreatmentsinphaseiandiiclinicaltrialsasystematicreviewinasthma AT frizzelliannalisa investigationaltreatmentsinphaseiandiiclinicaltrialsasystematicreviewinasthma AT pistocchinielena investigationaltreatmentsinphaseiandiiclinicaltrialsasystematicreviewinasthma AT ritondobeatriceludovica investigationaltreatmentsinphaseiandiiclinicaltrialsasystematicreviewinasthma AT roglianipaola investigationaltreatmentsinphaseiandiiclinicaltrialsasystematicreviewinasthma AT chettaalfredo investigationaltreatmentsinphaseiandiiclinicaltrialsasystematicreviewinasthma |