Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI

Kevin R. Murphy, Rajiv Dhand, Frank Trudo, Tom Uryniak, Ajay Aggarwal, Göran Eckerwall

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Rationale To assess equivalence of twice daily (bid) budesonide/formoterol (BUD/FM) 160/4.5 μg via breath-actuated metered-dose inhaler (BAI) versus pressurized metered-dose inhaler (pMDI). Methods This 12-week, double-blind, multicenter, parallel-group study, randomized adolescents and adults (aged ≥12 years) with asthma (and ≥3 months daily use of inhaled corticosteroids) to BUD/FM BAI 2 × 160/4.5 μg bid, BUD/FM pMDI 2 × 160/4.5 μg bid, or BUD pMDI 2 × 160 μg bid. Inclusion required prebronchodilator forced expiratory volume in one second (FEV1) ≥45 to ≤85% predicted, and reversibility of ≥12% in FEV (ages 12 to <18 years) or ≥12% and 200 mL (ages ≥18 years). Confirmation that 60-min postdose FEV response to BUD/FM pMDI was superior to BUD pMDI was required before equivalence testing. Therapeutic equivalence was shown by treatment effect ratio of BUD/FM BAI vs BUD/FM pMDI on 60-min postdose FEV and predose FEV within confidence intervals (CIs) of 80-125%. Results Mean age of 214 randomized patients was 42.7 years. BUD/FM pMDI was superior to BUD pMDI (60-min postdose FEV treatment effect ratio, 1.10; 95% CI, 1.06-1.14; p < 0.001). Treatment effect ratios for BUD/FM BAI versus pMDI for 60-min postdose FEV (1.01; 95% CI, 0.97-1.05) and predose FEV (1.03; 95% CI, 0.99-1.08) were within predetermined CIs for therapeutic equivalence. Adverse event profiles, tolerability, and patient-reported ease of use were similar. Conclusions BUD/FM 2 × 160/4.5 μg bid BAI is therapeutically equivalent to BUD/FM conventional pMDI. The introduction of BUD/FM BAI would expand options for delivering inhaled corticosteroid/long-acting β-agonist combination therapy to patients with moderate-to-severe asthma. ClinicalTrials.gov NCT01360021.

Original languageEnglish (US)
Pages (from-to)170-179
Number of pages10
JournalRespiratory Medicine
Volume109
Issue number2
DOIs
StatePublished - Feb 1 2015

Fingerprint

Metered Dose Inhalers
Budesonide
Nebulizers and Vaporizers
Confidence Intervals
Therapeutics
Adrenal Cortex Hormones
Formoterol Fumarate
Asthma
Forced Expiratory Volume

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine

Cite this

Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI. / Murphy, Kevin R.; Dhand, Rajiv; Trudo, Frank; Uryniak, Tom; Aggarwal, Ajay; Eckerwall, Göran.

In: Respiratory Medicine, Vol. 109, No. 2, 01.02.2015, p. 170-179.

Research output: Contribution to journalArticle

Murphy, Kevin R. ; Dhand, Rajiv ; Trudo, Frank ; Uryniak, Tom ; Aggarwal, Ajay ; Eckerwall, Göran. / Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI. In: Respiratory Medicine. 2015 ; Vol. 109, No. 2. pp. 170-179.
@article{9f59ab3cb1aa4118bc08e8460830eb41,
title = "Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI",
abstract = "Rationale To assess equivalence of twice daily (bid) budesonide/formoterol (BUD/FM) 160/4.5 μg via breath-actuated metered-dose inhaler (BAI) versus pressurized metered-dose inhaler (pMDI). Methods This 12-week, double-blind, multicenter, parallel-group study, randomized adolescents and adults (aged ≥12 years) with asthma (and ≥3 months daily use of inhaled corticosteroids) to BUD/FM BAI 2 × 160/4.5 μg bid, BUD/FM pMDI 2 × 160/4.5 μg bid, or BUD pMDI 2 × 160 μg bid. Inclusion required prebronchodilator forced expiratory volume in one second (FEV1) ≥45 to ≤85{\%} predicted, and reversibility of ≥12{\%} in FEV (ages 12 to <18 years) or ≥12{\%} and 200 mL (ages ≥18 years). Confirmation that 60-min postdose FEV response to BUD/FM pMDI was superior to BUD pMDI was required before equivalence testing. Therapeutic equivalence was shown by treatment effect ratio of BUD/FM BAI vs BUD/FM pMDI on 60-min postdose FEV and predose FEV within confidence intervals (CIs) of 80-125{\%}. Results Mean age of 214 randomized patients was 42.7 years. BUD/FM pMDI was superior to BUD pMDI (60-min postdose FEV treatment effect ratio, 1.10; 95{\%} CI, 1.06-1.14; p < 0.001). Treatment effect ratios for BUD/FM BAI versus pMDI for 60-min postdose FEV (1.01; 95{\%} CI, 0.97-1.05) and predose FEV (1.03; 95{\%} CI, 0.99-1.08) were within predetermined CIs for therapeutic equivalence. Adverse event profiles, tolerability, and patient-reported ease of use were similar. Conclusions BUD/FM 2 × 160/4.5 μg bid BAI is therapeutically equivalent to BUD/FM conventional pMDI. The introduction of BUD/FM BAI would expand options for delivering inhaled corticosteroid/long-acting β-agonist combination therapy to patients with moderate-to-severe asthma. ClinicalTrials.gov NCT01360021.",
author = "Murphy, {Kevin R.} and Rajiv Dhand and Frank Trudo and Tom Uryniak and Ajay Aggarwal and G{\"o}ran Eckerwall",
year = "2015",
month = "2",
day = "1",
doi = "10.1016/j.rmed.2014.12.009",
language = "English (US)",
volume = "109",
pages = "170--179",
journal = "Respiratory Medicine",
issn = "0954-6111",
publisher = "W.B. Saunders Ltd",
number = "2",

}

TY - JOUR

T1 - Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI

AU - Murphy, Kevin R.

AU - Dhand, Rajiv

AU - Trudo, Frank

AU - Uryniak, Tom

AU - Aggarwal, Ajay

AU - Eckerwall, Göran

PY - 2015/2/1

Y1 - 2015/2/1

N2 - Rationale To assess equivalence of twice daily (bid) budesonide/formoterol (BUD/FM) 160/4.5 μg via breath-actuated metered-dose inhaler (BAI) versus pressurized metered-dose inhaler (pMDI). Methods This 12-week, double-blind, multicenter, parallel-group study, randomized adolescents and adults (aged ≥12 years) with asthma (and ≥3 months daily use of inhaled corticosteroids) to BUD/FM BAI 2 × 160/4.5 μg bid, BUD/FM pMDI 2 × 160/4.5 μg bid, or BUD pMDI 2 × 160 μg bid. Inclusion required prebronchodilator forced expiratory volume in one second (FEV1) ≥45 to ≤85% predicted, and reversibility of ≥12% in FEV (ages 12 to <18 years) or ≥12% and 200 mL (ages ≥18 years). Confirmation that 60-min postdose FEV response to BUD/FM pMDI was superior to BUD pMDI was required before equivalence testing. Therapeutic equivalence was shown by treatment effect ratio of BUD/FM BAI vs BUD/FM pMDI on 60-min postdose FEV and predose FEV within confidence intervals (CIs) of 80-125%. Results Mean age of 214 randomized patients was 42.7 years. BUD/FM pMDI was superior to BUD pMDI (60-min postdose FEV treatment effect ratio, 1.10; 95% CI, 1.06-1.14; p < 0.001). Treatment effect ratios for BUD/FM BAI versus pMDI for 60-min postdose FEV (1.01; 95% CI, 0.97-1.05) and predose FEV (1.03; 95% CI, 0.99-1.08) were within predetermined CIs for therapeutic equivalence. Adverse event profiles, tolerability, and patient-reported ease of use were similar. Conclusions BUD/FM 2 × 160/4.5 μg bid BAI is therapeutically equivalent to BUD/FM conventional pMDI. The introduction of BUD/FM BAI would expand options for delivering inhaled corticosteroid/long-acting β-agonist combination therapy to patients with moderate-to-severe asthma. ClinicalTrials.gov NCT01360021.

AB - Rationale To assess equivalence of twice daily (bid) budesonide/formoterol (BUD/FM) 160/4.5 μg via breath-actuated metered-dose inhaler (BAI) versus pressurized metered-dose inhaler (pMDI). Methods This 12-week, double-blind, multicenter, parallel-group study, randomized adolescents and adults (aged ≥12 years) with asthma (and ≥3 months daily use of inhaled corticosteroids) to BUD/FM BAI 2 × 160/4.5 μg bid, BUD/FM pMDI 2 × 160/4.5 μg bid, or BUD pMDI 2 × 160 μg bid. Inclusion required prebronchodilator forced expiratory volume in one second (FEV1) ≥45 to ≤85% predicted, and reversibility of ≥12% in FEV (ages 12 to <18 years) or ≥12% and 200 mL (ages ≥18 years). Confirmation that 60-min postdose FEV response to BUD/FM pMDI was superior to BUD pMDI was required before equivalence testing. Therapeutic equivalence was shown by treatment effect ratio of BUD/FM BAI vs BUD/FM pMDI on 60-min postdose FEV and predose FEV within confidence intervals (CIs) of 80-125%. Results Mean age of 214 randomized patients was 42.7 years. BUD/FM pMDI was superior to BUD pMDI (60-min postdose FEV treatment effect ratio, 1.10; 95% CI, 1.06-1.14; p < 0.001). Treatment effect ratios for BUD/FM BAI versus pMDI for 60-min postdose FEV (1.01; 95% CI, 0.97-1.05) and predose FEV (1.03; 95% CI, 0.99-1.08) were within predetermined CIs for therapeutic equivalence. Adverse event profiles, tolerability, and patient-reported ease of use were similar. Conclusions BUD/FM 2 × 160/4.5 μg bid BAI is therapeutically equivalent to BUD/FM conventional pMDI. The introduction of BUD/FM BAI would expand options for delivering inhaled corticosteroid/long-acting β-agonist combination therapy to patients with moderate-to-severe asthma. ClinicalTrials.gov NCT01360021.

UR - http://www.scopus.com/inward/record.url?scp=84923105370&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84923105370&partnerID=8YFLogxK

U2 - 10.1016/j.rmed.2014.12.009

DO - 10.1016/j.rmed.2014.12.009

M3 - Article

VL - 109

SP - 170

EP - 179

JO - Respiratory Medicine

JF - Respiratory Medicine

SN - 0954-6111

IS - 2

ER -