Petr Pohunek1, Guido Varoli2, Yuriy Reznichenko3, Svetlana Mokia-Serbina4, Jerzy Brzostek5, Viktoriya Kostromina6, Mykola Kaladze7, Annamaria Muraro2, Elena Carzana2, Silvia Armani2, Jadwiga Kaczmarek8. 1. Paediatric Department, University Hospital Motol, V Uvalu 84, 150 06, Praha, Czech Republic. petr.pohunek@LFMotol.cuni.cz. 2. Global Clinical Development, Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy. 3. Pulmonology Department of Community Institution "Zaporizhzhya Regional Clinical Child Hospital" of Zaporizhzhya Regional Council, Zaporizhzhya State Medical University, 70 Lenina str, Zaporizhzhya, 69063, Ukraine. 4. City Clinical Hospital № 8, 55, 23rd Lyutogo str., Kryvyi Rog, Ukraine. 5. Poradnia Alergologiczna, ZOZ Debica, ul., Krakowska 91, 39-200, Debica, Poland. 6. Department of Child Pulmonology and Allergology, State Institution "National Institute of Physiatry and Pulmonology n.a. F.G. Yanovskyy of AMS of Ukraine", 10, Amosova str., Kyiv, 03680, Ukraine. 7. 1st City Children Clinical Association of Simferopol City, Department of Pulmonology, Simferopol, Department of Pediatry with Physiotherapy Course of Faculty of Postgraduate Education, State Institution "Crimean State Medical University n.a. S.I. Georgiyivskiy", 31, K. Libknehta, Simferopol, Crimea, Russia. 8. Outpatient Clinic of Allergology, Kopcinskiego Str 22, 90-153, Lodz, Poland.
Abstract
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 Plus™ 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 ≥ 5 and < 12 years. Primary efficacy variable was forced expiratory volume during the first second (FEV1) area under the curve corrected by time over 12 h following morning dose (AUC0-12h). 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. FEV1 AUC0-12h of each CHF1535 dose vs placebo were 0.037 L (p = 0.160), 0.119 L (p < 0.001), and 0.094 (p < 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 β2- 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.
RCT Entities:
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 Plus™ 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 ≥ 5 and < 12 years. Primary efficacy variable was forced expiratory volume during the first second (FEV1) area under the curve corrected by time over 12 h following morning dose (AUC0-12h). 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. FEV1 AUC0-12h of each CHF1535 dose vs placebo were 0.037 L (p = 0.160), 0.119 L (p < 0.001), and 0.094 (p < 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 β2- 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.
Authors: Margaret E Kemeny; Lanny J Rosenwasser; Reynold A Panettieri; Robert M Rose; Steve M Berg-Smith; Joel N Kline Journal: J Allergy Clin Immunol Date: 2007-04-23 Impact factor: 10.793