Effect of nebulized arformoterol on airway function in COPD: Results from two randomized trials

John P. Hanrahan, Nicola A. Hanania, William Calhoun, Steven A. Sahn, Kenneth Sciarappa, Rudolf A. Baumgartner

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Rationale: Arformoterol, a single isomer long-acting β2-agonist, was developed as an inhalation solution for the maintenance treatment of bronchoconstriction in COPD. Methods: The pulmonary function efficacy of nebulized arformoterol (15 μg BID, 25 μg BID, 50 μg QD) and salmeterol MDI (42 μg BID) versus placebo was assessed in 1456 subjects (mean FEV1 1.2L, mean predicted 41%). Data were pooled from 2 identical, 12-week, double-blind, randomized trials. The percent change in trough FEV1, percent change in FEV1 average AUC(0 - 12 hrs) and peak percent change FEV1 from predose were analyzed. Results: Improvement in trough FEV1 averaged over 12 weeks was greater for arformoterol and salmeterol versus placebo (mean differences from placebo [95% CI] arformoterol-15 μg BID: 11.4% [8.4, 14.3]; 25 μg BID: 15.4% [12.2, 18.6]; 50 μg QD: 10.9% [7.9, 13.9]); salmeterol: (11.6% [8.8, 14.4]). Greater improvements versus placebo occurred after the first dose (mean differences between arformoterol and placebo for trough FEV1: 13-19%; FEV1 AUC(0 - 12 hrs): 19-24%; peak percent change: 20-25%) and at week 12 (trough FEV1: 10-13%; FEV1 AUC(0 - 12 hrs): 6-13%; peak percent change: 7-14%); all 95% CIs excluded zero. Increases in FEV1 AUC(0 - 12 hrs) and peak percent change were greater for arformoterol than for salmeterol (95% CIs excluded zero). After 12 weeks, 78-87% of arformoterol subjects had ≥ 10% increases in FEV1 from pre-dose (56% salmeterol, 44% placebo); the median time to response was 3-13 minutes (142 minutes salmeterol). Conclusions: In these trials, COPD subjects administered nebulized arformoterol demonstrated significant and sustained improvement in lung function over 12 weeks.

Original languageEnglish (US)
Pages (from-to)25-34
Number of pages10
JournalCOPD: Journal of Chronic Obstructive Pulmonary Disease
Volume5
Issue number1
DOIs
StatePublished - Feb 2008

Fingerprint

Chronic Obstructive Pulmonary Disease
Placebos
Area Under Curve
Lung
Bronchoconstriction
Formoterol Fumarate
Inhalation
Salmeterol Xinafoate

Keywords

  • Chronic obstructive pulmonary disease
  • Inhalation solution
  • Long-acting β-agonists
  • Lung function
  • Placebo-controlled
  • Pulmonary function testing

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Effect of nebulized arformoterol on airway function in COPD : Results from two randomized trials. / Hanrahan, John P.; Hanania, Nicola A.; Calhoun, William; Sahn, Steven A.; Sciarappa, Kenneth; Baumgartner, Rudolf A.

In: COPD: Journal of Chronic Obstructive Pulmonary Disease, Vol. 5, No. 1, 02.2008, p. 25-34.

Research output: Contribution to journalArticle

Hanrahan, John P. ; Hanania, Nicola A. ; Calhoun, William ; Sahn, Steven A. ; Sciarappa, Kenneth ; Baumgartner, Rudolf A. / Effect of nebulized arformoterol on airway function in COPD : Results from two randomized trials. In: COPD: Journal of Chronic Obstructive Pulmonary Disease. 2008 ; Vol. 5, No. 1. pp. 25-34.
@article{1869505ea9b14f599d2a89f39d51340c,
title = "Effect of nebulized arformoterol on airway function in COPD: Results from two randomized trials",
abstract = "Rationale: Arformoterol, a single isomer long-acting β2-agonist, was developed as an inhalation solution for the maintenance treatment of bronchoconstriction in COPD. Methods: The pulmonary function efficacy of nebulized arformoterol (15 μg BID, 25 μg BID, 50 μg QD) and salmeterol MDI (42 μg BID) versus placebo was assessed in 1456 subjects (mean FEV1 1.2L, mean predicted 41{\%}). Data were pooled from 2 identical, 12-week, double-blind, randomized trials. The percent change in trough FEV1, percent change in FEV1 average AUC(0 - 12 hrs) and peak percent change FEV1 from predose were analyzed. Results: Improvement in trough FEV1 averaged over 12 weeks was greater for arformoterol and salmeterol versus placebo (mean differences from placebo [95{\%} CI] arformoterol-15 μg BID: 11.4{\%} [8.4, 14.3]; 25 μg BID: 15.4{\%} [12.2, 18.6]; 50 μg QD: 10.9{\%} [7.9, 13.9]); salmeterol: (11.6{\%} [8.8, 14.4]). Greater improvements versus placebo occurred after the first dose (mean differences between arformoterol and placebo for trough FEV1: 13-19{\%}; FEV1 AUC(0 - 12 hrs): 19-24{\%}; peak percent change: 20-25{\%}) and at week 12 (trough FEV1: 10-13{\%}; FEV1 AUC(0 - 12 hrs): 6-13{\%}; peak percent change: 7-14{\%}); all 95{\%} CIs excluded zero. Increases in FEV1 AUC(0 - 12 hrs) and peak percent change were greater for arformoterol than for salmeterol (95{\%} CIs excluded zero). After 12 weeks, 78-87{\%} of arformoterol subjects had ≥ 10{\%} increases in FEV1 from pre-dose (56{\%} salmeterol, 44{\%} placebo); the median time to response was 3-13 minutes (142 minutes salmeterol). Conclusions: In these trials, COPD subjects administered nebulized arformoterol demonstrated significant and sustained improvement in lung function over 12 weeks.",
keywords = "Chronic obstructive pulmonary disease, Inhalation solution, Long-acting β-agonists, Lung function, Placebo-controlled, Pulmonary function testing",
author = "Hanrahan, {John P.} and Hanania, {Nicola A.} and William Calhoun and Sahn, {Steven A.} and Kenneth Sciarappa and Baumgartner, {Rudolf A.}",
year = "2008",
month = "2",
doi = "10.1080/15412550701816187",
language = "English (US)",
volume = "5",
pages = "25--34",
journal = "COPD: Journal of Chronic Obstructive Pulmonary Disease",
issn = "1541-2555",
publisher = "Informa Healthcare",
number = "1",

}

TY - JOUR

T1 - Effect of nebulized arformoterol on airway function in COPD

T2 - Results from two randomized trials

AU - Hanrahan, John P.

AU - Hanania, Nicola A.

AU - Calhoun, William

AU - Sahn, Steven A.

AU - Sciarappa, Kenneth

AU - Baumgartner, Rudolf A.

PY - 2008/2

Y1 - 2008/2

N2 - Rationale: Arformoterol, a single isomer long-acting β2-agonist, was developed as an inhalation solution for the maintenance treatment of bronchoconstriction in COPD. Methods: The pulmonary function efficacy of nebulized arformoterol (15 μg BID, 25 μg BID, 50 μg QD) and salmeterol MDI (42 μg BID) versus placebo was assessed in 1456 subjects (mean FEV1 1.2L, mean predicted 41%). Data were pooled from 2 identical, 12-week, double-blind, randomized trials. The percent change in trough FEV1, percent change in FEV1 average AUC(0 - 12 hrs) and peak percent change FEV1 from predose were analyzed. Results: Improvement in trough FEV1 averaged over 12 weeks was greater for arformoterol and salmeterol versus placebo (mean differences from placebo [95% CI] arformoterol-15 μg BID: 11.4% [8.4, 14.3]; 25 μg BID: 15.4% [12.2, 18.6]; 50 μg QD: 10.9% [7.9, 13.9]); salmeterol: (11.6% [8.8, 14.4]). Greater improvements versus placebo occurred after the first dose (mean differences between arformoterol and placebo for trough FEV1: 13-19%; FEV1 AUC(0 - 12 hrs): 19-24%; peak percent change: 20-25%) and at week 12 (trough FEV1: 10-13%; FEV1 AUC(0 - 12 hrs): 6-13%; peak percent change: 7-14%); all 95% CIs excluded zero. Increases in FEV1 AUC(0 - 12 hrs) and peak percent change were greater for arformoterol than for salmeterol (95% CIs excluded zero). After 12 weeks, 78-87% of arformoterol subjects had ≥ 10% increases in FEV1 from pre-dose (56% salmeterol, 44% placebo); the median time to response was 3-13 minutes (142 minutes salmeterol). Conclusions: In these trials, COPD subjects administered nebulized arformoterol demonstrated significant and sustained improvement in lung function over 12 weeks.

AB - Rationale: Arformoterol, a single isomer long-acting β2-agonist, was developed as an inhalation solution for the maintenance treatment of bronchoconstriction in COPD. Methods: The pulmonary function efficacy of nebulized arformoterol (15 μg BID, 25 μg BID, 50 μg QD) and salmeterol MDI (42 μg BID) versus placebo was assessed in 1456 subjects (mean FEV1 1.2L, mean predicted 41%). Data were pooled from 2 identical, 12-week, double-blind, randomized trials. The percent change in trough FEV1, percent change in FEV1 average AUC(0 - 12 hrs) and peak percent change FEV1 from predose were analyzed. Results: Improvement in trough FEV1 averaged over 12 weeks was greater for arformoterol and salmeterol versus placebo (mean differences from placebo [95% CI] arformoterol-15 μg BID: 11.4% [8.4, 14.3]; 25 μg BID: 15.4% [12.2, 18.6]; 50 μg QD: 10.9% [7.9, 13.9]); salmeterol: (11.6% [8.8, 14.4]). Greater improvements versus placebo occurred after the first dose (mean differences between arformoterol and placebo for trough FEV1: 13-19%; FEV1 AUC(0 - 12 hrs): 19-24%; peak percent change: 20-25%) and at week 12 (trough FEV1: 10-13%; FEV1 AUC(0 - 12 hrs): 6-13%; peak percent change: 7-14%); all 95% CIs excluded zero. Increases in FEV1 AUC(0 - 12 hrs) and peak percent change were greater for arformoterol than for salmeterol (95% CIs excluded zero). After 12 weeks, 78-87% of arformoterol subjects had ≥ 10% increases in FEV1 from pre-dose (56% salmeterol, 44% placebo); the median time to response was 3-13 minutes (142 minutes salmeterol). Conclusions: In these trials, COPD subjects administered nebulized arformoterol demonstrated significant and sustained improvement in lung function over 12 weeks.

KW - Chronic obstructive pulmonary disease

KW - Inhalation solution

KW - Long-acting β-agonists

KW - Lung function

KW - Placebo-controlled

KW - Pulmonary function testing

UR - http://www.scopus.com/inward/record.url?scp=38949204853&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=38949204853&partnerID=8YFLogxK

U2 - 10.1080/15412550701816187

DO - 10.1080/15412550701816187

M3 - Article

C2 - 18259972

AN - SCOPUS:38949204853

VL - 5

SP - 25

EP - 34

JO - COPD: Journal of Chronic Obstructive Pulmonary Disease

JF - COPD: Journal of Chronic Obstructive Pulmonary Disease

SN - 1541-2555

IS - 1

ER -