Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy

Mitchell P. Dombrowski, Michael Schatz, Robert Wise, Elizabeth A. Thom, Mark Landon, William Mabie, Roger B. Newman, Donald McNellis, John C. Hauth, Marshall Lindheimer, Steve N. Caritis, Kenneth J. Leveno, Paul Meis, Menachem Miodovnik, Ronald J. Wapner, Michael W. Varner, Mary Jo O'Sullivan, Deborah L. Conway

Research output: Contribution to journalArticle

71 Citations (Scopus)

Abstract

Objective: This study was undertaken to compare the efficacy of inhaled beclomethasone dipropionate to oral theophylline for the prevention of asthma exacerbation(s) requiring medical intervention. Study design: A prospective, double-blind, double placebo-controlled randomized clinical trial of pregnant women with moderate asthma was performed. Results: There was no significant difference (P = .554) in the proportion of asthma exacerbations among the 194 women in the beclomethasone cohort (18.0%) versus the 191 in the theophylline cohort (20.4%; risk ratio [RR] = 0.9, 95% CI = 0.6-1.3). The beclomethasone cohort had significantly lower incidences of discontinuing study medications caused by side effects (RR = 0.3, 95% CI = 0.1-0.9; P = .016), and proportion of study visits with forced expiratory volume expired in 1 second (FEV1) less than 80% predicted (0.284 ± 0.331 vs 0.284 ± 0.221, P = .039). There were no significant differences in treatment failure, compliance, or proportion of peak expiratory flow rate less than 80% predicted. There were no significant differences in maternal or perinatal outcomes. Conclusion: The treatment of moderate asthma with inhaled beclomethasone versus oral theophylline resulted in similar rates of asthma exacerbations and similar obstetric and perinatal outcomes. These results favor the use of inhaled corticosteroids for moderate asthma during pregnancy because of the improved FEV1 and because theophylline had more side effects and requires serum monitoring.

Original languageEnglish
Pages (from-to)737-744
Number of pages8
JournalAmerican Journal of Obstetrics and Gynecology
Volume190
Issue number3
DOIs
StatePublished - Mar 1 2004
Externally publishedYes

Fingerprint

Beclomethasone
Theophylline
Asthma
Pregnancy
Forced Expiratory Volume
Odds Ratio
Peak Expiratory Flow Rate
Treatment Failure
Compliance
Obstetrics
Pregnant Women
Adrenal Cortex Hormones
Cohort Studies
Randomized Controlled Trials
Placebos
Mothers
Serum

Keywords

  • Asthma
  • Beclomethasone
  • Pregnancy
  • Theophylline

ASJC Scopus subject areas

  • Medicine(all)
  • Obstetrics and Gynecology

Cite this

Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy. / Dombrowski, Mitchell P.; Schatz, Michael; Wise, Robert; Thom, Elizabeth A.; Landon, Mark; Mabie, William; Newman, Roger B.; McNellis, Donald; Hauth, John C.; Lindheimer, Marshall; Caritis, Steve N.; Leveno, Kenneth J.; Meis, Paul; Miodovnik, Menachem; Wapner, Ronald J.; Varner, Michael W.; O'Sullivan, Mary Jo; Conway, Deborah L.

In: American Journal of Obstetrics and Gynecology, Vol. 190, No. 3, 01.03.2004, p. 737-744.

Research output: Contribution to journalArticle

Dombrowski, MP, Schatz, M, Wise, R, Thom, EA, Landon, M, Mabie, W, Newman, RB, McNellis, D, Hauth, JC, Lindheimer, M, Caritis, SN, Leveno, KJ, Meis, P, Miodovnik, M, Wapner, RJ, Varner, MW, O'Sullivan, MJ & Conway, DL 2004, 'Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy', American Journal of Obstetrics and Gynecology, vol. 190, no. 3, pp. 737-744. https://doi.org/10.1016/j.ajog.2003.09.071
Dombrowski, Mitchell P. ; Schatz, Michael ; Wise, Robert ; Thom, Elizabeth A. ; Landon, Mark ; Mabie, William ; Newman, Roger B. ; McNellis, Donald ; Hauth, John C. ; Lindheimer, Marshall ; Caritis, Steve N. ; Leveno, Kenneth J. ; Meis, Paul ; Miodovnik, Menachem ; Wapner, Ronald J. ; Varner, Michael W. ; O'Sullivan, Mary Jo ; Conway, Deborah L. / Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy. In: American Journal of Obstetrics and Gynecology. 2004 ; Vol. 190, No. 3. pp. 737-744.
@article{9d279078e81d4ba580291f3042052fc1,
title = "Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy",
abstract = "Objective: This study was undertaken to compare the efficacy of inhaled beclomethasone dipropionate to oral theophylline for the prevention of asthma exacerbation(s) requiring medical intervention. Study design: A prospective, double-blind, double placebo-controlled randomized clinical trial of pregnant women with moderate asthma was performed. Results: There was no significant difference (P = .554) in the proportion of asthma exacerbations among the 194 women in the beclomethasone cohort (18.0{\%}) versus the 191 in the theophylline cohort (20.4{\%}; risk ratio [RR] = 0.9, 95{\%} CI = 0.6-1.3). The beclomethasone cohort had significantly lower incidences of discontinuing study medications caused by side effects (RR = 0.3, 95{\%} CI = 0.1-0.9; P = .016), and proportion of study visits with forced expiratory volume expired in 1 second (FEV1) less than 80{\%} predicted (0.284 ± 0.331 vs 0.284 ± 0.221, P = .039). There were no significant differences in treatment failure, compliance, or proportion of peak expiratory flow rate less than 80{\%} predicted. There were no significant differences in maternal or perinatal outcomes. Conclusion: The treatment of moderate asthma with inhaled beclomethasone versus oral theophylline resulted in similar rates of asthma exacerbations and similar obstetric and perinatal outcomes. These results favor the use of inhaled corticosteroids for moderate asthma during pregnancy because of the improved FEV1 and because theophylline had more side effects and requires serum monitoring.",
keywords = "Asthma, Beclomethasone, Pregnancy, Theophylline",
author = "Dombrowski, {Mitchell P.} and Michael Schatz and Robert Wise and Thom, {Elizabeth A.} and Mark Landon and William Mabie and Newman, {Roger B.} and Donald McNellis and Hauth, {John C.} and Marshall Lindheimer and Caritis, {Steve N.} and Leveno, {Kenneth J.} and Paul Meis and Menachem Miodovnik and Wapner, {Ronald J.} and Varner, {Michael W.} and O'Sullivan, {Mary Jo} and Conway, {Deborah L.}",
year = "2004",
month = "3",
day = "1",
doi = "10.1016/j.ajog.2003.09.071",
language = "English",
volume = "190",
pages = "737--744",
journal = "American Journal of Obstetrics and Gynecology",
issn = "0002-9378",
publisher = "Mosby Inc.",
number = "3",

}

TY - JOUR

T1 - Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy

AU - Dombrowski, Mitchell P.

AU - Schatz, Michael

AU - Wise, Robert

AU - Thom, Elizabeth A.

AU - Landon, Mark

AU - Mabie, William

AU - Newman, Roger B.

AU - McNellis, Donald

AU - Hauth, John C.

AU - Lindheimer, Marshall

AU - Caritis, Steve N.

AU - Leveno, Kenneth J.

AU - Meis, Paul

AU - Miodovnik, Menachem

AU - Wapner, Ronald J.

AU - Varner, Michael W.

AU - O'Sullivan, Mary Jo

AU - Conway, Deborah L.

PY - 2004/3/1

Y1 - 2004/3/1

N2 - Objective: This study was undertaken to compare the efficacy of inhaled beclomethasone dipropionate to oral theophylline for the prevention of asthma exacerbation(s) requiring medical intervention. Study design: A prospective, double-blind, double placebo-controlled randomized clinical trial of pregnant women with moderate asthma was performed. Results: There was no significant difference (P = .554) in the proportion of asthma exacerbations among the 194 women in the beclomethasone cohort (18.0%) versus the 191 in the theophylline cohort (20.4%; risk ratio [RR] = 0.9, 95% CI = 0.6-1.3). The beclomethasone cohort had significantly lower incidences of discontinuing study medications caused by side effects (RR = 0.3, 95% CI = 0.1-0.9; P = .016), and proportion of study visits with forced expiratory volume expired in 1 second (FEV1) less than 80% predicted (0.284 ± 0.331 vs 0.284 ± 0.221, P = .039). There were no significant differences in treatment failure, compliance, or proportion of peak expiratory flow rate less than 80% predicted. There were no significant differences in maternal or perinatal outcomes. Conclusion: The treatment of moderate asthma with inhaled beclomethasone versus oral theophylline resulted in similar rates of asthma exacerbations and similar obstetric and perinatal outcomes. These results favor the use of inhaled corticosteroids for moderate asthma during pregnancy because of the improved FEV1 and because theophylline had more side effects and requires serum monitoring.

AB - Objective: This study was undertaken to compare the efficacy of inhaled beclomethasone dipropionate to oral theophylline for the prevention of asthma exacerbation(s) requiring medical intervention. Study design: A prospective, double-blind, double placebo-controlled randomized clinical trial of pregnant women with moderate asthma was performed. Results: There was no significant difference (P = .554) in the proportion of asthma exacerbations among the 194 women in the beclomethasone cohort (18.0%) versus the 191 in the theophylline cohort (20.4%; risk ratio [RR] = 0.9, 95% CI = 0.6-1.3). The beclomethasone cohort had significantly lower incidences of discontinuing study medications caused by side effects (RR = 0.3, 95% CI = 0.1-0.9; P = .016), and proportion of study visits with forced expiratory volume expired in 1 second (FEV1) less than 80% predicted (0.284 ± 0.331 vs 0.284 ± 0.221, P = .039). There were no significant differences in treatment failure, compliance, or proportion of peak expiratory flow rate less than 80% predicted. There were no significant differences in maternal or perinatal outcomes. Conclusion: The treatment of moderate asthma with inhaled beclomethasone versus oral theophylline resulted in similar rates of asthma exacerbations and similar obstetric and perinatal outcomes. These results favor the use of inhaled corticosteroids for moderate asthma during pregnancy because of the improved FEV1 and because theophylline had more side effects and requires serum monitoring.

KW - Asthma

KW - Beclomethasone

KW - Pregnancy

KW - Theophylline

UR - http://www.scopus.com/inward/record.url?scp=12144287028&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=12144287028&partnerID=8YFLogxK

U2 - 10.1016/j.ajog.2003.09.071

DO - 10.1016/j.ajog.2003.09.071

M3 - Article

C2 - 15042007

AN - SCOPUS:12144287028

VL - 190

SP - 737

EP - 744

JO - American Journal of Obstetrics and Gynecology

JF - American Journal of Obstetrics and Gynecology

SN - 0002-9378

IS - 3

ER -