Bronchodilating effects of a new beclometasone dipropionate plus formoterol fumarate formulation via pressurized metered-dose inhaler in asthmatic children: a double-blind, randomized, cross-over clinical study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F21%3A10419475" target="_blank" >RIV/00064203:_____/21:10419475 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11130/21:10419475

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=QyW26m7b~t" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=QyW26m7b~t</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s00431-020-03888-x" target="_blank" >10.1007/s00431-020-03888-x</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Bronchodilating effects of a new beclometasone dipropionate plus formoterol fumarate formulation via pressurized metered-dose inhaler in asthmatic children: a double-blind, randomized, cross-over clinical study

Popis výsledku v původním jazyce

A new pediatric fixed combination of beclometasone dipropionate (BDP) 50 μg and formoterol fumarate (FF) 6 μg via pressurized metered-dose inhaler (pMDI) (CHF1535, Chiesi, Italy) was investigated. In a double-blind, randomized, placebo-controlled, cross-over study, a single CHF1535 administration using AeroChamber PlusTM spacer device (2 actuations, total dose BDP 100 μg/FF 12 μg) was compared to the same pMDI free combination in 56 asthmatic children aged &gt;= 5 and &lt; 12 years. Primary efficacy variable was forced expiratory volume during the first second (FEV(1)) area under the curve corrected by time over 12 h following morning dose (AUC(0-12h)). Further CHF1535 doses (50 μg/6 μg, 100 μg/12 μg, and 200 μg/24 μg) were also explored. Adverse events, electrocardiogram, and vital signs were monitored for safety. CHF1535 was non-inferior to free combination [adjusted mean difference (95% CI) 0.004 L (- 0.050, 0.041] with lower confidence limit greater than the limit set at 0.1 L. FEV(1) AUC(0-12h) of each CHF1535 dose vs placebo were 0.037 L (p = 0.160), 0.119 L (p &lt; 0.001), and 0.094 (p &lt; 0.001) for 50/6, 100/12, and 200/24, respectively. No safety signals were found.Conclusion: CHF1535 was as effective as free combination BDP/FF, with a trend towards a dose-related response. All treatments were safe.Trial registration: ClinicalTrials.gov ID: NCT01584492 What is Known: .Inhaled pressurized metered-dose solutions (pMDI) are the preferred treatment for pediatric asthma. .Combination therapy of inhaled corticosteroids and long-acting β(2)- agonists is a well-established approach to control airway inflammation and airway obstruction also in pediatric patients. What is New: .A novel pediatric pMDI fixed combination of beclomethasone dipropionate 50 μg and formoterol fumarate 6 μg (CHF 1535) was non-inferior to the free combination at the same dose in pulmonary function over the 12-h post-dose period in asthmatic children, with trend towards a dose-related response.

Název v anglickém jazyce

Bronchodilating effects of a new beclometasone dipropionate plus formoterol fumarate formulation via pressurized metered-dose inhaler in asthmatic children: a double-blind, randomized, cross-over clinical study

Popis výsledku anglicky

A new pediatric fixed combination of beclometasone dipropionate (BDP) 50 μg and formoterol fumarate (FF) 6 μg via pressurized metered-dose inhaler (pMDI) (CHF1535, Chiesi, Italy) was investigated. In a double-blind, randomized, placebo-controlled, cross-over study, a single CHF1535 administration using AeroChamber PlusTM spacer device (2 actuations, total dose BDP 100 μg/FF 12 μg) was compared to the same pMDI free combination in 56 asthmatic children aged &gt;= 5 and &lt; 12 years. Primary efficacy variable was forced expiratory volume during the first second (FEV(1)) area under the curve corrected by time over 12 h following morning dose (AUC(0-12h)). Further CHF1535 doses (50 μg/6 μg, 100 μg/12 μg, and 200 μg/24 μg) were also explored. Adverse events, electrocardiogram, and vital signs were monitored for safety. CHF1535 was non-inferior to free combination [adjusted mean difference (95% CI) 0.004 L (- 0.050, 0.041] with lower confidence limit greater than the limit set at 0.1 L. FEV(1) AUC(0-12h) of each CHF1535 dose vs placebo were 0.037 L (p = 0.160), 0.119 L (p &lt; 0.001), and 0.094 (p &lt; 0.001) for 50/6, 100/12, and 200/24, respectively. No safety signals were found.Conclusion: CHF1535 was as effective as free combination BDP/FF, with a trend towards a dose-related response. All treatments were safe.Trial registration: ClinicalTrials.gov ID: NCT01584492 What is Known: .Inhaled pressurized metered-dose solutions (pMDI) are the preferred treatment for pediatric asthma. .Combination therapy of inhaled corticosteroids and long-acting β(2)- agonists is a well-established approach to control airway inflammation and airway obstruction also in pediatric patients. What is New: .A novel pediatric pMDI fixed combination of beclomethasone dipropionate 50 μg and formoterol fumarate 6 μg (CHF 1535) was non-inferior to the free combination at the same dose in pulmonary function over the 12-h post-dose period in asthmatic children, with trend towards a dose-related response.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30209 - Paediatrics

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

European Journal of Pediatrics

ISSN

0340-6199

e-ISSN

—

Svazek periodika

180

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

DE - Spolková republika Německo

Počet stran výsledku

9

Strana od-do

1467-1475

Kód UT WoS článku

000605501900002

EID výsledku v databázi Scopus

2-s2.0-85099215766