Comparison of the effect of beclometasone/formoterol in asthma patients after methacholine-induced bronchoconstriction: a non-inferiority study using metered dose versus dry powder inhaler

Dave Singh, Frans van den Berg, Brian Leaker, Massimo Corradi, Sunny Jabbal, Sara Collarini, Valentina Mongelli, Luigi Santoro, Annalisa Piccinno (Lead / Corresponding author), Sonia Biondaro, Brian Lipworth

Research output: Contribution to journalArticle

1 Citation (Scopus)
9 Downloads (Pure)

Abstract

Aim: To demonstrate the non-inferiority of extrafine beclomethasone/formoterol Fumarate (BDP/FF) dry powder inhaler (DPI) vs extrafine BDP/FF pressurised metered dose inhaler (pMDI) (Foster® 100/6 μg NEXThaler® and pMDI, respectively) in the onset of reliever effect after methacholine induced bronchospasm in asthmatic patients, evaluated in terms of FEV1 at 5 min post-dose. The DPI provides an alternative device option for patients who cannot use a pMDI properly during an acute asthma attack.

Methods: Sixty-five patients received one inhalation of BDP/FF DPI, BDP/FF pMDI or placebo after methacholine challenge, according to a double-blind, double-dummy, cross-over design. Lung function and Borg dyspnoea score were assessed up to 30 min post-dose.

Results: FEV1 adjusted mean difference between BDP/FF DPI and BDP/FF pMDI at 5 min post-dose was 2 ml (95% CI: -0.060; 0.065). A similar result was observed at the other time points. Median time to 85% recovery in FEV1 was 8 min for BDP/FF DPI, 7.5 min for BDP/FF pMDI and 28 min for placebo (p = 0.554 DPI vs pMDI). The Borg score improved after treatment with both BDP/FF DPI and pMDI and the effect was greater than after placebo. Median time to reach 50% recovery was 4.2 min for BDP/FF DPI, 4.0 min for BDP/FF pMDI and 10.0 min for placebo (p = 0.609 DPI vs pMDI).

Conclusions: Extrafine Foster® NEXThaler®, a flow independent DPI, is comparable to extrafine Foster® pMDI when administered as reliever therapy after methacholine challenge, thus supporting the Maintenance And Reliever Therapy (MART) approach also with NEXThaler®.

Original languageEnglish
Number of pages21
JournalBritish Journal of Clinical Pharmacology
Early online date26 Dec 2018
DOIs
Publication statusE-pub ahead of print - 26 Dec 2018

Fingerprint

Dry Powder Inhalers
Beclomethasone
Metered Dose Inhalers
Bronchoconstriction
Methacholine Chloride
Asthma
Placebos
Formoterol Fumarate
Bronchial Spasm
Dyspnea
Cross-Over Studies
Inhalation
Therapeutics

Cite this

Singh, Dave ; van den Berg, Frans ; Leaker, Brian ; Corradi, Massimo ; Jabbal, Sunny ; Collarini, Sara ; Mongelli, Valentina ; Santoro, Luigi ; Piccinno, Annalisa ; Biondaro, Sonia ; Lipworth, Brian. / Comparison of the effect of beclometasone/formoterol in asthma patients after methacholine-induced bronchoconstriction : a non-inferiority study using metered dose versus dry powder inhaler. In: British Journal of Clinical Pharmacology. 2018.
@article{97b1dd8622df4d579c574c3e39885f00,
title = "Comparison of the effect of beclometasone/formoterol in asthma patients after methacholine-induced bronchoconstriction: a non-inferiority study using metered dose versus dry powder inhaler",
abstract = "Aim: To demonstrate the non-inferiority of extrafine beclomethasone/formoterol Fumarate (BDP/FF) dry powder inhaler (DPI) vs extrafine BDP/FF pressurised metered dose inhaler (pMDI) (Foster{\circledR} 100/6 μg NEXThaler{\circledR} and pMDI, respectively) in the onset of reliever effect after methacholine induced bronchospasm in asthmatic patients, evaluated in terms of FEV1 at 5 min post-dose. The DPI provides an alternative device option for patients who cannot use a pMDI properly during an acute asthma attack.Methods: Sixty-five patients received one inhalation of BDP/FF DPI, BDP/FF pMDI or placebo after methacholine challenge, according to a double-blind, double-dummy, cross-over design. Lung function and Borg dyspnoea score were assessed up to 30 min post-dose.Results: FEV1 adjusted mean difference between BDP/FF DPI and BDP/FF pMDI at 5 min post-dose was 2 ml (95{\%} CI: -0.060; 0.065). A similar result was observed at the other time points. Median time to 85{\%} recovery in FEV1 was 8 min for BDP/FF DPI, 7.5 min for BDP/FF pMDI and 28 min for placebo (p = 0.554 DPI vs pMDI). The Borg score improved after treatment with both BDP/FF DPI and pMDI and the effect was greater than after placebo. Median time to reach 50{\%} recovery was 4.2 min for BDP/FF DPI, 4.0 min for BDP/FF pMDI and 10.0 min for placebo (p = 0.609 DPI vs pMDI).Conclusions: Extrafine Foster{\circledR} NEXThaler{\circledR}, a flow independent DPI, is comparable to extrafine Foster{\circledR} pMDI when administered as reliever therapy after methacholine challenge, thus supporting the Maintenance And Reliever Therapy (MART) approach also with NEXThaler{\circledR}.",
author = "Dave Singh and {van den Berg}, Frans and Brian Leaker and Massimo Corradi and Sunny Jabbal and Sara Collarini and Valentina Mongelli and Luigi Santoro and Annalisa Piccinno and Sonia Biondaro and Brian Lipworth",
note = "This article is protected by copyright. All rights reserved.",
year = "2018",
month = "12",
day = "26",
doi = "10.1111/bcp.13847",
language = "English",
journal = "British Journal of Clinical Pharmacology",
issn = "0306-5251",
publisher = "Wiley",

}

Comparison of the effect of beclometasone/formoterol in asthma patients after methacholine-induced bronchoconstriction : a non-inferiority study using metered dose versus dry powder inhaler. / Singh, Dave; van den Berg, Frans; Leaker, Brian; Corradi, Massimo; Jabbal, Sunny; Collarini, Sara; Mongelli, Valentina; Santoro, Luigi; Piccinno, Annalisa (Lead / Corresponding author); Biondaro, Sonia; Lipworth, Brian.

In: British Journal of Clinical Pharmacology, 26.12.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparison of the effect of beclometasone/formoterol in asthma patients after methacholine-induced bronchoconstriction

T2 - a non-inferiority study using metered dose versus dry powder inhaler

AU - Singh, Dave

AU - van den Berg, Frans

AU - Leaker, Brian

AU - Corradi, Massimo

AU - Jabbal, Sunny

AU - Collarini, Sara

AU - Mongelli, Valentina

AU - Santoro, Luigi

AU - Piccinno, Annalisa

AU - Biondaro, Sonia

AU - Lipworth, Brian

N1 - This article is protected by copyright. All rights reserved.

PY - 2018/12/26

Y1 - 2018/12/26

N2 - Aim: To demonstrate the non-inferiority of extrafine beclomethasone/formoterol Fumarate (BDP/FF) dry powder inhaler (DPI) vs extrafine BDP/FF pressurised metered dose inhaler (pMDI) (Foster® 100/6 μg NEXThaler® and pMDI, respectively) in the onset of reliever effect after methacholine induced bronchospasm in asthmatic patients, evaluated in terms of FEV1 at 5 min post-dose. The DPI provides an alternative device option for patients who cannot use a pMDI properly during an acute asthma attack.Methods: Sixty-five patients received one inhalation of BDP/FF DPI, BDP/FF pMDI or placebo after methacholine challenge, according to a double-blind, double-dummy, cross-over design. Lung function and Borg dyspnoea score were assessed up to 30 min post-dose.Results: FEV1 adjusted mean difference between BDP/FF DPI and BDP/FF pMDI at 5 min post-dose was 2 ml (95% CI: -0.060; 0.065). A similar result was observed at the other time points. Median time to 85% recovery in FEV1 was 8 min for BDP/FF DPI, 7.5 min for BDP/FF pMDI and 28 min for placebo (p = 0.554 DPI vs pMDI). The Borg score improved after treatment with both BDP/FF DPI and pMDI and the effect was greater than after placebo. Median time to reach 50% recovery was 4.2 min for BDP/FF DPI, 4.0 min for BDP/FF pMDI and 10.0 min for placebo (p = 0.609 DPI vs pMDI).Conclusions: Extrafine Foster® NEXThaler®, a flow independent DPI, is comparable to extrafine Foster® pMDI when administered as reliever therapy after methacholine challenge, thus supporting the Maintenance And Reliever Therapy (MART) approach also with NEXThaler®.

AB - Aim: To demonstrate the non-inferiority of extrafine beclomethasone/formoterol Fumarate (BDP/FF) dry powder inhaler (DPI) vs extrafine BDP/FF pressurised metered dose inhaler (pMDI) (Foster® 100/6 μg NEXThaler® and pMDI, respectively) in the onset of reliever effect after methacholine induced bronchospasm in asthmatic patients, evaluated in terms of FEV1 at 5 min post-dose. The DPI provides an alternative device option for patients who cannot use a pMDI properly during an acute asthma attack.Methods: Sixty-five patients received one inhalation of BDP/FF DPI, BDP/FF pMDI or placebo after methacholine challenge, according to a double-blind, double-dummy, cross-over design. Lung function and Borg dyspnoea score were assessed up to 30 min post-dose.Results: FEV1 adjusted mean difference between BDP/FF DPI and BDP/FF pMDI at 5 min post-dose was 2 ml (95% CI: -0.060; 0.065). A similar result was observed at the other time points. Median time to 85% recovery in FEV1 was 8 min for BDP/FF DPI, 7.5 min for BDP/FF pMDI and 28 min for placebo (p = 0.554 DPI vs pMDI). The Borg score improved after treatment with both BDP/FF DPI and pMDI and the effect was greater than after placebo. Median time to reach 50% recovery was 4.2 min for BDP/FF DPI, 4.0 min for BDP/FF pMDI and 10.0 min for placebo (p = 0.609 DPI vs pMDI).Conclusions: Extrafine Foster® NEXThaler®, a flow independent DPI, is comparable to extrafine Foster® pMDI when administered as reliever therapy after methacholine challenge, thus supporting the Maintenance And Reliever Therapy (MART) approach also with NEXThaler®.

U2 - 10.1111/bcp.13847

DO - 10.1111/bcp.13847

M3 - Article

C2 - 30586199

JO - British Journal of Clinical Pharmacology

JF - British Journal of Clinical Pharmacology

SN - 0306-5251

ER -