Prednisolone oral solution plus inhaled procaterol for acute asthma in children: A double-blind randomized controlled trial

Li-Hsin Huang, Shyh-Dar Shyur, Da-Chin Wen, Yi-Chi Chang, Yi-Chun Ma, Sheng-Chieh Lin, Wen-Chiu Wu, Jiunn-Yi Wu

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: To evaluate the efficacy of prednisolone sodium phosphate oral solution plus inhaled procaterol in the treatment of acute asthma in children. Methods: Forty-three patients aged 6 to 12 years with an acute exacerbation of asthma were double-blind randomized into one of two treatment groups in a 1:1 ratio:1) prednisolone oral solution +placebo tablets + procaterol MDI or 2) prednisolone tablets +placebo oral solution + procaterol MDI, all given three times daily for 7 days. Peak expiratory flow rate (PEFR), 24-hour reflective asthma symptom scores, spirometry and pulmonary index score (PIS) were recorded before and after treatment. Net changes in PEFR, symptom score, PIS, Forced Expiratory Volume in the first second (FEV1), FEV1/forced vital capacity (FVC), forced expiratory flow between 25 and 75 percent of the forced vital capacity (FEF25-75%) (before and after treatment) and global assessment by the investigator and the subjects or their parents were analyzed. Results: The two groups were statistically similar at baseline values of these parameters. After a 7-day course of treatment, the net change of PEFR before and after treatment was significantly improved in both groups, but there was no significant difference in the net change of PEFR between the two groups (57.27 ± 31.44 L/min vs. 54.29 ± 30.04 L/min, difference 2.99 ± 30.76L/min, mean ± SD, P=0.752). The net change in PIS and total symptom score did not differ between the two groups (P=0.091 and 0.827, respectively). Similarly, the FEV1, FEV1/FVC and FEF25-75% all improved with either treatment, and neither group was significantly superior to the other group (P=0.162, 0.48 and 0.081, respectively). Global assessment by the investigator and the subjects or their parents at the end of study indicated an essentially comparable result. Conclusions: Prednisolone sodium phosphate oral solution plus inhaled procaterol is as efficacious as prednisolone tablets plus inhaled procaterol in the management of acute asthma in children.
Original languageEnglish
Pages (from-to)257
Number of pages1
JournalActa Paediatrica Taiwanica
Volume48
Issue number5
Publication statusPublished - 2007
Externally publishedYes

Fingerprint

Procaterol
Prednisolone
Asthma
Randomized Controlled Trials
Peak Expiratory Flow Rate
Vital Capacity
Tablets
Lung
Therapeutics
Parents
Placebos
Research Personnel
Spirometry
Forced Expiratory Volume

Keywords

  • Acute asthma
  • Prednisolone
  • Solution
  • Tablet
  • placebo
  • prednisolone
  • procaterol
  • abdominal pain
  • allergic reaction
  • article
  • asthma
  • breathing rate
  • child
  • clinical article
  • clinical trial
  • combination chemotherapy
  • controlled clinical trial
  • controlled study
  • disease severity
  • double blind procedure
  • drug efficacy
  • expiratory flow rate
  • forced expiratory volume
  • human
  • randomized controlled trial
  • spirometry
  • tremor
  • Acute Disease
  • Administration, Inhalation
  • Administration, Oral
  • Asthma
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Forced Expiratory Volume
  • Humans
  • Male
  • Procaterol

Cite this

Prednisolone oral solution plus inhaled procaterol for acute asthma in children: A double-blind randomized controlled trial. / Huang, Li-Hsin; Shyur, Shyh-Dar; Wen, Da-Chin; Chang, Yi-Chi; Ma, Yi-Chun; Lin, Sheng-Chieh; Wu, Wen-Chiu; Wu, Jiunn-Yi.

In: Acta Paediatrica Taiwanica, Vol. 48, No. 5, 2007, p. 257.

Research output: Contribution to journalArticle

Huang, L-H, Shyur, S-D, Wen, D-C, Chang, Y-C, Ma, Y-C, Lin, S-C, Wu, W-C & Wu, J-Y 2007, 'Prednisolone oral solution plus inhaled procaterol for acute asthma in children: A double-blind randomized controlled trial', Acta Paediatrica Taiwanica, vol. 48, no. 5, pp. 257.
Huang, Li-Hsin ; Shyur, Shyh-Dar ; Wen, Da-Chin ; Chang, Yi-Chi ; Ma, Yi-Chun ; Lin, Sheng-Chieh ; Wu, Wen-Chiu ; Wu, Jiunn-Yi. / Prednisolone oral solution plus inhaled procaterol for acute asthma in children: A double-blind randomized controlled trial. In: Acta Paediatrica Taiwanica. 2007 ; Vol. 48, No. 5. pp. 257.
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title = "Prednisolone oral solution plus inhaled procaterol for acute asthma in children: A double-blind randomized controlled trial",
abstract = "Background: To evaluate the efficacy of prednisolone sodium phosphate oral solution plus inhaled procaterol in the treatment of acute asthma in children. Methods: Forty-three patients aged 6 to 12 years with an acute exacerbation of asthma were double-blind randomized into one of two treatment groups in a 1:1 ratio:1) prednisolone oral solution +placebo tablets + procaterol MDI or 2) prednisolone tablets +placebo oral solution + procaterol MDI, all given three times daily for 7 days. Peak expiratory flow rate (PEFR), 24-hour reflective asthma symptom scores, spirometry and pulmonary index score (PIS) were recorded before and after treatment. Net changes in PEFR, symptom score, PIS, Forced Expiratory Volume in the first second (FEV1), FEV1/forced vital capacity (FVC), forced expiratory flow between 25 and 75 percent of the forced vital capacity (FEF25-75{\%}) (before and after treatment) and global assessment by the investigator and the subjects or their parents were analyzed. Results: The two groups were statistically similar at baseline values of these parameters. After a 7-day course of treatment, the net change of PEFR before and after treatment was significantly improved in both groups, but there was no significant difference in the net change of PEFR between the two groups (57.27 ± 31.44 L/min vs. 54.29 ± 30.04 L/min, difference 2.99 ± 30.76L/min, mean ± SD, P=0.752). The net change in PIS and total symptom score did not differ between the two groups (P=0.091 and 0.827, respectively). Similarly, the FEV1, FEV1/FVC and FEF25-75{\%} all improved with either treatment, and neither group was significantly superior to the other group (P=0.162, 0.48 and 0.081, respectively). Global assessment by the investigator and the subjects or their parents at the end of study indicated an essentially comparable result. Conclusions: Prednisolone sodium phosphate oral solution plus inhaled procaterol is as efficacious as prednisolone tablets plus inhaled procaterol in the management of acute asthma in children.",
keywords = "Acute asthma, Prednisolone, Solution, Tablet, placebo, prednisolone, procaterol, abdominal pain, allergic reaction, article, asthma, breathing rate, child, clinical article, clinical trial, combination chemotherapy, controlled clinical trial, controlled study, disease severity, double blind procedure, drug efficacy, expiratory flow rate, forced expiratory volume, human, randomized controlled trial, spirometry, tremor, Acute Disease, Administration, Inhalation, Administration, Oral, Asthma, Child, Child, Preschool, Double-Blind Method, Female, Forced Expiratory Volume, Humans, Male, Procaterol",
author = "Li-Hsin Huang and Shyh-Dar Shyur and Da-Chin Wen and Yi-Chi Chang and Yi-Chun Ma and Sheng-Chieh Lin and Wen-Chiu Wu and Jiunn-Yi Wu",
note = "Export Date: 7 April 2016 CODEN: TEYZF 通訊地址: Shyur, S.-D.; Allergy and Immunology Section, Department of Pediatrics, Mackay Memorial Hospital, 92, Chungshan North Road, Taipei, Taiwan; 電子郵件: abc1016@ms2.mmh.org.tw 化學物質/CAS: prednisolone, 50-24-8; procaterol, 62929-91-3, 72332-33-3; Prednisolone, 50-24-8; Procaterol, 72332-33-3 參考文獻: Shapiro, G.G., Steroids and asthma (1995) Pediatrics, 96, pp. 347-348; Rubin, B.K., Marcushamer, S., Priel, I., App, E.M., Emergency management of the child with asthma (1990) Pediatr Pulmonol, 8, pp. 45-57; Rowe, B.H., Keller, J.L., Oxman, A.D., Effectiveness of steroid therapy in acute exacerbations of asthma: A metaanalysis (1992) Am J Emerg Med, 10, pp. 301-310; Schleimer, R.P., Effects of glucocorticosteroids on inflammatory cells relevant to their therapeutic applications in asthma (1990) Am Rev Respir Dis, 141, pp. S59-S69; McGill, K., Joseph, B., Busse, W., Corticosteroids in the treatment of asthma: Practical recommendations (1995) Clin Immunother, 4, pp. 16-48; Kulick, R.M., Ruddy, R.M., (2000) Textbook of Pediatric Emergency Medicine, , 4th ed. Philadelphia: Lippincott Williams & Wilkins;; Deshpande, A., McKenzie, S.A., Short course of steroids in home treatment of children with acute asthma (1986) Br Med J (Clin Res Ed), 293, pp. 169-171; Steele, R.W., Estrada, B., Begue, R.E., Mirza, A., Travillion, D.A., Thomas, M.P., A double-blind taste comparison of pediatric antibiotic suspensions (1997) Clin Pediatr (Phila), 36, pp. 193-199; Isa, J.M., Wong, G.K., Teraoka, S.S., Sera, M.J., Tsushima, M.M., Yamamoto, L.G., Parental pediatric corticosteroid preferences (2001) Am J Emerg Med, 19, pp. 29-31; Delgado, A., Chou, K.J., Silver, E.J., Crain, E.F., Nebulizers vs metered-dose inhalers with spacers for bronchodilator therapy to treat wheezing in children aged 2 to 24 months in a pediatric emergency department (2003) Arch Pediatr Adolesc Med, 157, pp. 76-80; Huang, L.H., Shyur, S.D., Weng, J.D., Chuo, H.T., Ma, Y.C., Lin, S.C., The short-term influence of self-management principles and skills on asthmatic children (2004) Journal of Pediatric Pulmonology, 4, pp. 88-94; Quanjer, P.H., Stocks, J., Polgar, G., Wise, M., Karlberg, J., Borsboom, G., Compilation of reference values for lung function measurements in children (1989) Eur Respir J Suppl, 4, pp. 184-261; Quanjer, P.H., Tammeling, G.J., Cotes, J.E., Pedersen, O.F., Peslin, R., Yernault, J.C., Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory (1993) Society. Eur Respir J Suppl, 16, pp. 5-40; Shyur, S.-D., Wang, C.-Y., Wu, C.-Y., Chao, Y.-K., The predicted PEFR normal reference data of elementary school children in Taipei area (2002) Taiwan Journal of Family Medicine, 12, pp. 121-128; Roy, S.R., Milgrom, H., Management of the acute exacerbation of asthma (2003) J Asthma, 40, pp. 593-604; Georgitis, J.W., Flesher, K.A., Szefler, S.J., Bioavailability assessment of a liquid prednisone preparation (1982) J Allergy Clin Immunol, 70, pp. 243-247; Fleisher, D., Johnson, K.C., Stewart, B.H., Amidon, G.L., Oral absorption of 21-corticosteroid esters: A function of aqueous stability and intestinal enzyme activity and distribution (1986) J Pharm Sci, 75, pp. 934-939; Nuhoglu, Y., Bahceciler, N.N., Barlan, I.B., Mujdat Basaran, M., The effectiveness of high-dose inhaled budesonide therapy in the treatment of acute asthma exacerbations in children (2001) Ann Allergy Asthma Immunol, 86, pp. 318-322; Nakanishi, A.K., Klasner, A.K., Rubin, B.K., A randomized controlled trial of inhaled flunisolide in the management of acute asthma in children (2003) Chest, 124, pp. 790-794; Lucas-Bouwman, M.E., Roorda, R.J., Jansman, F.G., Brand, P.L., Crushed prednisolone tablets or oral solution for acute asthma? (2001) Arch Dis Child, 84, pp. 347-348; Dawson, K.P., Sharpe, C., A comparison of the acceptability of prednisolone tablets and prednisolone sodium phosphate solution in childhood acute asthma (1993) Aust J Hosp Pharm, 23, pp. 320-323; Hutto, C.J., Bratton, T.H., Palatability and cost comparison of five liquid corticosteroid formulations (1999) J Pediatr Oncol Nurs, 16, pp. 74-77",
year = "2007",
language = "English",
volume = "48",
pages = "257",
journal = "Pediatrics and Neonatology",
issn = "1875-9572",
publisher = "臺灣兒科醫學會",
number = "5",

}

TY - JOUR

T1 - Prednisolone oral solution plus inhaled procaterol for acute asthma in children: A double-blind randomized controlled trial

AU - Huang, Li-Hsin

AU - Shyur, Shyh-Dar

AU - Wen, Da-Chin

AU - Chang, Yi-Chi

AU - Ma, Yi-Chun

AU - Lin, Sheng-Chieh

AU - Wu, Wen-Chiu

AU - Wu, Jiunn-Yi

N1 - Export Date: 7 April 2016 CODEN: TEYZF 通訊地址: Shyur, S.-D.; Allergy and Immunology Section, Department of Pediatrics, Mackay Memorial Hospital, 92, Chungshan North Road, Taipei, Taiwan; 電子郵件: abc1016@ms2.mmh.org.tw 化學物質/CAS: prednisolone, 50-24-8; procaterol, 62929-91-3, 72332-33-3; Prednisolone, 50-24-8; Procaterol, 72332-33-3 參考文獻: Shapiro, G.G., Steroids and asthma (1995) Pediatrics, 96, pp. 347-348; Rubin, B.K., Marcushamer, S., Priel, I., App, E.M., Emergency management of the child with asthma (1990) Pediatr Pulmonol, 8, pp. 45-57; Rowe, B.H., Keller, J.L., Oxman, A.D., Effectiveness of steroid therapy in acute exacerbations of asthma: A metaanalysis (1992) Am J Emerg Med, 10, pp. 301-310; Schleimer, R.P., Effects of glucocorticosteroids on inflammatory cells relevant to their therapeutic applications in asthma (1990) Am Rev Respir Dis, 141, pp. S59-S69; McGill, K., Joseph, B., Busse, W., Corticosteroids in the treatment of asthma: Practical recommendations (1995) Clin Immunother, 4, pp. 16-48; Kulick, R.M., Ruddy, R.M., (2000) Textbook of Pediatric Emergency Medicine, , 4th ed. Philadelphia: Lippincott Williams & Wilkins;; Deshpande, A., McKenzie, S.A., Short course of steroids in home treatment of children with acute asthma (1986) Br Med J (Clin Res Ed), 293, pp. 169-171; Steele, R.W., Estrada, B., Begue, R.E., Mirza, A., Travillion, D.A., Thomas, M.P., A double-blind taste comparison of pediatric antibiotic suspensions (1997) Clin Pediatr (Phila), 36, pp. 193-199; Isa, J.M., Wong, G.K., Teraoka, S.S., Sera, M.J., Tsushima, M.M., Yamamoto, L.G., Parental pediatric corticosteroid preferences (2001) Am J Emerg Med, 19, pp. 29-31; Delgado, A., Chou, K.J., Silver, E.J., Crain, E.F., Nebulizers vs metered-dose inhalers with spacers for bronchodilator therapy to treat wheezing in children aged 2 to 24 months in a pediatric emergency department (2003) Arch Pediatr Adolesc Med, 157, pp. 76-80; Huang, L.H., Shyur, S.D., Weng, J.D., Chuo, H.T., Ma, Y.C., Lin, S.C., The short-term influence of self-management principles and skills on asthmatic children (2004) Journal of Pediatric Pulmonology, 4, pp. 88-94; Quanjer, P.H., Stocks, J., Polgar, G., Wise, M., Karlberg, J., Borsboom, G., Compilation of reference values for lung function measurements in children (1989) Eur Respir J Suppl, 4, pp. 184-261; Quanjer, P.H., Tammeling, G.J., Cotes, J.E., Pedersen, O.F., Peslin, R., Yernault, J.C., Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory (1993) Society. Eur Respir J Suppl, 16, pp. 5-40; Shyur, S.-D., Wang, C.-Y., Wu, C.-Y., Chao, Y.-K., The predicted PEFR normal reference data of elementary school children in Taipei area (2002) Taiwan Journal of Family Medicine, 12, pp. 121-128; Roy, S.R., Milgrom, H., Management of the acute exacerbation of asthma (2003) J Asthma, 40, pp. 593-604; Georgitis, J.W., Flesher, K.A., Szefler, S.J., Bioavailability assessment of a liquid prednisone preparation (1982) J Allergy Clin Immunol, 70, pp. 243-247; Fleisher, D., Johnson, K.C., Stewart, B.H., Amidon, G.L., Oral absorption of 21-corticosteroid esters: A function of aqueous stability and intestinal enzyme activity and distribution (1986) J Pharm Sci, 75, pp. 934-939; Nuhoglu, Y., Bahceciler, N.N., Barlan, I.B., Mujdat Basaran, M., The effectiveness of high-dose inhaled budesonide therapy in the treatment of acute asthma exacerbations in children (2001) Ann Allergy Asthma Immunol, 86, pp. 318-322; Nakanishi, A.K., Klasner, A.K., Rubin, B.K., A randomized controlled trial of inhaled flunisolide in the management of acute asthma in children (2003) Chest, 124, pp. 790-794; Lucas-Bouwman, M.E., Roorda, R.J., Jansman, F.G., Brand, P.L., Crushed prednisolone tablets or oral solution for acute asthma? (2001) Arch Dis Child, 84, pp. 347-348; Dawson, K.P., Sharpe, C., A comparison of the acceptability of prednisolone tablets and prednisolone sodium phosphate solution in childhood acute asthma (1993) Aust J Hosp Pharm, 23, pp. 320-323; Hutto, C.J., Bratton, T.H., Palatability and cost comparison of five liquid corticosteroid formulations (1999) J Pediatr Oncol Nurs, 16, pp. 74-77

PY - 2007

Y1 - 2007

N2 - Background: To evaluate the efficacy of prednisolone sodium phosphate oral solution plus inhaled procaterol in the treatment of acute asthma in children. Methods: Forty-three patients aged 6 to 12 years with an acute exacerbation of asthma were double-blind randomized into one of two treatment groups in a 1:1 ratio:1) prednisolone oral solution +placebo tablets + procaterol MDI or 2) prednisolone tablets +placebo oral solution + procaterol MDI, all given three times daily for 7 days. Peak expiratory flow rate (PEFR), 24-hour reflective asthma symptom scores, spirometry and pulmonary index score (PIS) were recorded before and after treatment. Net changes in PEFR, symptom score, PIS, Forced Expiratory Volume in the first second (FEV1), FEV1/forced vital capacity (FVC), forced expiratory flow between 25 and 75 percent of the forced vital capacity (FEF25-75%) (before and after treatment) and global assessment by the investigator and the subjects or their parents were analyzed. Results: The two groups were statistically similar at baseline values of these parameters. After a 7-day course of treatment, the net change of PEFR before and after treatment was significantly improved in both groups, but there was no significant difference in the net change of PEFR between the two groups (57.27 ± 31.44 L/min vs. 54.29 ± 30.04 L/min, difference 2.99 ± 30.76L/min, mean ± SD, P=0.752). The net change in PIS and total symptom score did not differ between the two groups (P=0.091 and 0.827, respectively). Similarly, the FEV1, FEV1/FVC and FEF25-75% all improved with either treatment, and neither group was significantly superior to the other group (P=0.162, 0.48 and 0.081, respectively). Global assessment by the investigator and the subjects or their parents at the end of study indicated an essentially comparable result. Conclusions: Prednisolone sodium phosphate oral solution plus inhaled procaterol is as efficacious as prednisolone tablets plus inhaled procaterol in the management of acute asthma in children.

AB - Background: To evaluate the efficacy of prednisolone sodium phosphate oral solution plus inhaled procaterol in the treatment of acute asthma in children. Methods: Forty-three patients aged 6 to 12 years with an acute exacerbation of asthma were double-blind randomized into one of two treatment groups in a 1:1 ratio:1) prednisolone oral solution +placebo tablets + procaterol MDI or 2) prednisolone tablets +placebo oral solution + procaterol MDI, all given three times daily for 7 days. Peak expiratory flow rate (PEFR), 24-hour reflective asthma symptom scores, spirometry and pulmonary index score (PIS) were recorded before and after treatment. Net changes in PEFR, symptom score, PIS, Forced Expiratory Volume in the first second (FEV1), FEV1/forced vital capacity (FVC), forced expiratory flow between 25 and 75 percent of the forced vital capacity (FEF25-75%) (before and after treatment) and global assessment by the investigator and the subjects or their parents were analyzed. Results: The two groups were statistically similar at baseline values of these parameters. After a 7-day course of treatment, the net change of PEFR before and after treatment was significantly improved in both groups, but there was no significant difference in the net change of PEFR between the two groups (57.27 ± 31.44 L/min vs. 54.29 ± 30.04 L/min, difference 2.99 ± 30.76L/min, mean ± SD, P=0.752). The net change in PIS and total symptom score did not differ between the two groups (P=0.091 and 0.827, respectively). Similarly, the FEV1, FEV1/FVC and FEF25-75% all improved with either treatment, and neither group was significantly superior to the other group (P=0.162, 0.48 and 0.081, respectively). Global assessment by the investigator and the subjects or their parents at the end of study indicated an essentially comparable result. Conclusions: Prednisolone sodium phosphate oral solution plus inhaled procaterol is as efficacious as prednisolone tablets plus inhaled procaterol in the management of acute asthma in children.

KW - Acute asthma

KW - Prednisolone

KW - Solution

KW - Tablet

KW - placebo

KW - prednisolone

KW - procaterol

KW - abdominal pain

KW - allergic reaction

KW - article

KW - asthma

KW - breathing rate

KW - child

KW - clinical article

KW - clinical trial

KW - combination chemotherapy

KW - controlled clinical trial

KW - controlled study

KW - disease severity

KW - double blind procedure

KW - drug efficacy

KW - expiratory flow rate

KW - forced expiratory volume

KW - human

KW - randomized controlled trial

KW - spirometry

KW - tremor

KW - Acute Disease

KW - Administration, Inhalation

KW - Administration, Oral

KW - Asthma

KW - Child

KW - Child, Preschool

KW - Double-Blind Method

KW - Female

KW - Forced Expiratory Volume

KW - Humans

KW - Male

KW - Procaterol

M3 - Article

VL - 48

SP - 257

JO - Pediatrics and Neonatology

JF - Pediatrics and Neonatology

SN - 1875-9572

IS - 5

ER -