A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma.

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Abstrakt

Tytuł:: A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma.
Autorzy:: Weinstein CLJ; Merck & Co Inc, Kenilworth, New Jersey.
Gates D; Merck & Co Inc, Kenilworth, New Jersey.
Zhang X; Merck & Co Inc, Kenilworth, New Jersey.
Varnell T; Merck & Co Inc, Kenilworth, New Jersey.
Mok W; Merck & Co Inc, Kenilworth, New Jersey.
Vermeulen JH; Panorama Medical Centre, Panorama, Cape Town, South Africa.
Amar NJ; Allergy Asthma Research Institute, Waco, Texas.
Jain N; Arizona Allergy and Immunology Research LLC, Gilbert, Arizona.
Źródło:: Pediatric pulmonology [Pediatr Pulmonol] 2020 Apr; Vol. 55 (4), pp. 882-889. Date of Electronic Publication: 2020 Feb 05.
Typ publikacji:: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Publication: <2005-> : Hoboken, NJ : Wiley-Liss
Original Publication: [Philadelphia, PA] : W.B. Saunders, [c1985-
MeSH Terms:: Asthma/*drug therapy
Bronchodilator Agents/*administration & dosage
Formoterol Fumarate/*administration & dosage
Mometasone Furoate/*administration & dosage
Administration, Inhalation ; Adrenal Cortex Hormones/therapeutic use ; Bronchodilator Agents/adverse effects ; Child ; Child, Preschool ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Formoterol Fumarate/adverse effects ; Humans ; Male ; Metered Dose Inhalers ; Mometasone Furoate/adverse effects ; Nebulizers and Vaporizers ; Spirometry ; Treatment Outcome
References:: Weinstein CL, Gates D, Zhang X, et al. P211 Efficacy and safety of mometasone furoate/formoterol compared with mometasone furoate in children with persistent asthma. Ann Allergy Asthma Immunol. 2019;123(suppl):S35.
Centers for Disease Control and Prevention. Most recent national asthma data. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. Accessed May 1, 2019.
Global Initiative for Asthma. https://ginasthma.org/. Accessed January 18, 2019.
US prescribing information for ASMANEX® HFA (mometasone furoate). https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205641s007s008lbl.pdf. Accessed May 1, 2019.
US prescribing information for ASMANEX® TWISTHALER® 110 mcg, 220 mcg (mometasone furoate inhalation powder) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021067s026,s028lbl.pdf. Accessed May 1, 2019.
Winkler J, Hochhaus G, Derendorf H. How the lung handles drugs: pharmacokinetics and pharmacodynamics of inhaled corticosteroids. Proc Am Thorac Soc. 2004;1:356-363.
US prescribing information for FORADIL® (formoterol fumarate). https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021592s003lbl.pdf. Accessed May 1, 2019.
US prescribing information for DULERA® (mometasone furoate and formoterol fumarate dihydrate). https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s023s024lbl.pdf. Accessed May 1, 2019.
Weinstein C, Staudinger H, Scott I, Amar NJ, Laforce C. Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD. Respir Med. 2011;105:979-988.
LaForce C, Weinstein C, Nathan RA, Weinstein SF, Staudinger H, Meltzer EO. Patient satisfaction with a pressurized metered-dose inhaler with an integrated dose counter containing a fixed-dose mometasone furoate/formoterol combination. J Asthma. 2011;48:625-631.
Berger WE, Bensch GW, Weinstein SF, et al. Bronchodilation with mometasone furoate/formoterol fumarate administered by metered-dose inhaler with and without a spacer in children with persistent asthma. Pediatr Pulmonol. 2014;49:441-450.
Amar NJ, Shekar T, Varnell TA, Mehta A, Philip G. Mometasone furoate (MF) improves lung function in pediatric asthma: a double-blind, randomized controlled dose-ranging trial of MF metered-dose inhaler. Pediatr Pulmonol. 2017;52:310-318. https://doi.org/10.1002/ppul.23563. Erratum: Pediatr Pulmonol. 2019;54:655-656. https://doi.org/10.1002/ppul.24291.
Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J. 2005;26:319-338.
Polgar G, Promadhat V. Pulmonary Function Testing in Children: Techniques and Standards. Philadelphia, PA: Saunders; 1971.
Ratitch B, O'Kelly M, Tosiello R. Missing data in clinical trials: from clinical assumptions to statistical analysis using pattern mixture models. Pharm Stat. 2013;12:337-347.
Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4:213-226.
Skoner DP, Meltzer EO, Milgrom H, Stryszak P, Teper A, Staudinger H. Effects of inhaled mometasone furoate on growth velocity and adrenal function: a placebo-controlled trial in children 4-9 years old with mild persistent asthma. J Asthma. 2011;48:848-859.
Busse WW, Bateman ED, Caplan AL, et al. Combined analysis of asthma safety trials of long-acting beta(2)-agonists. N Engl J Med. 2018;378:2497-2505.
Stempel DA, Szefler SJ, Pedersen S, et al. Safety of adding salmeterol to fluticasone propionate in children with asthma. N Engl J Med. 2016;375:840-849.
Contributed Indexing:: Keywords: children; formoterol; mometasone furoate; persistent asthma
Substance Nomenclature:: 0 (Adrenal Cortex Hormones)
0 (Bronchodilator Agents)
04201GDN4R (Mometasone Furoate)
W34SHF8J2K (Formoterol Fumarate)
Entry Date(s):: Date Created: 20200206 Date Completed: 20201109 Latest Revision: 20201109
Update Code:: 20240105
DOI:: 10.1002/ppul.24667
PMID:: 32022483
: Czasopismo naukowe

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Objectives: Asthma affects over 6 million children in the United States alone. This study investigated the efficacy and long-term safety of mometasone furoate-formoterol (MF/F) and MF monotherapy in children with asthma.
Materials and Methods: This phase 3, multicenter, randomized controlled trial evaluated metered-dose inhaler twice daily (BID) dosing with MF/F 100/10 µg or MF 100 µg in children, aged 5 to 11 years, with a history of asthma for greater than or equal to 6 months and confirmed bronchodilator reversibility, who were adequately controlled on inhaled corticosteroid/long-acting beta-agonist combination therapy for greater than or equal to 4 weeks. After a 2-week run-in on MF 100 µg BID, eligible patients received 24 weeks of double-blind treatment and were followed for safety up to 26 weeks. The primary efficacy endpoint was the change from baseline in AM postdose 60-minute AUC %predicted FEV1% across 12 weeks of treatment.
Results: A total of 181 participants received at least one dose of MF/F (n = 91) or MF (n = 90). MF/F was superior to MF across the 12-week evaluation period, with a treatment advantage of 5.21 percentage points (P < .001). Superior onset of action with MF/F over MF was achieved as early as 5 minutes postdose on day 1. Overall, approximately 50% of participants experienced one or more treatment-emergent adverse events, with fewer occurring in the MF/F group.
Conclusions: In children 5 to 11 years of age with persistent asthma, the addition of F to MF was well tolerated and provided significant, rapid, and sustained improvement in lung function compared with MF alone.
(© 2020 Wiley Periodicals, Inc.)

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