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Study record managers: refer to the Data Element Definitions if submitting registration or results information. Practice guidelines for the management of asthma in children universally recommend systemic corticosteroids for the treatment of moderate to severe asthma exacerbations. However, these guidelines vary widely with respect to dose, frequency, method of delivery, and duration of therapy.
In actual practice, there is also considerable variation among clinicians in terms of corticosteroid dosing in children hospitalized with asthma exacerbations. Systematic reviews of the literature have called for a clinical trial to evaluate the effect of different doses of corticosteroids in treating pediatric asthma patients hospitalized with exacerbations. This study will use a randomized, double-blind, controlled trial design in order to compare the efficacy of two different steroid doses in resolving acute exacerbations of asthma in hospitalized children.
Children being hospitalized for asthma exacerbations from the CHOP emergency department ED will be eligible for study enrollment. Those that meet enrollment criteria will be randomized to receive prednisolone either in the higher dose 1. Once 48 hours has past, all patients still hospitalized will receive 1.
Approximately patients with 78 in each arm of the study will be enrolled. This study should be completed in six to eight months. A non-inferiority study design will be used. The primary outcome will be duration of hospitalization, as determined by duration of time elapsed from first dose of prednisolone administered in the emergency department ED until the discharge dose of albuterol is administered.
Secondary outcomes will include time elapsed from the time the admission order is written until the discharge order is written, time spent in each severity level of the asthma care pathway, degree and rate of improvement in forced expiratory volume in one second FEV1improvement in peak expiratory flows PEFimprovement in asthma symptom scores, and rate of relapse after discharge.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. We're building a better ClinicalTrials.
Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Oral Prednisolone Dosing in Children Hospitalized With Asthma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details. Results First Posted : August 11, Last Update Posted : December 31, Study Description. This study hopes to determine the appropriate oral steroid dose for treating children hospitalized with asthma exacerbations.
Practice guidelines from different countries recommend a wide range of doses, and the doses used in actual practice vary widely. There is no data on what is the most appropriate dose of prednisone or equivalent in this situation.
We will be looking at the dose recommended by the National Asthma Education and Prevention Program guidelines, which are published by the National Heart, Lung, and Blood Institute, as compared with a lower dose which is commonly used in practice.
We hypothesize that the lower dose will be no worse than the higher dose as determined primarily by duration of hospitalization. Detailed Description:. Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate. FDA Resources. Arms and Interventions. Other Names: Low dose Prednisolone Oral prednisolone Oral steriod corticosteriods asthma exacerbations.
Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Physician-diagnosed asthma with at least two previous visits to ED or primary care provider for asthma care Clinical decision by ED attending physician to admit to Acute Care Unit ACU after standardized initial ED treatment Exclusion Criteria: Clinical decision to begin continuous intravenous beta-agonist infusion Clinical decision to begin intravenous methylprednisolone therapy Clinical decision to admit to the Pediatric Intensive Care Unit Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac disease Any contraindication to corticosteroid administration Any systemic corticosteroid treatment within two weeks of presenting to the ED Potential subjects will be excluded if informed consent is not obtained.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Layout table for additonal information Responsible Party: Joseph J. Zorc, M. Corticosteroids Treatment Pediatric. National Library of Medicine U. National Institutes of Health U.
Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Drug: Prednisolone high dose Drug: Prednisolone lower dose. Phase 4. Study Type :. Interventional Clinical Trial. Actual Enrollment :.
Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. Active Comparator: 1 High dose prednisolone. Experimental: 2 Lower dose prednisolone alternating with placebo. Philadelphia, Pennsylvania, United States, Joseph J. November 24, Key Record Dates.
For children over 5 years use a dose of mg (ml) prednisolone. For children aged years use a dose of 20mg (2ml) prednisolone. Those already receiving. Children and Adolescents: Oral: 1 to 2 mg/kg/day administered in the morning for 2 to 3 weeks; maximum daily dose: 60 mg/day; if no response after 7 to 14 days. Prednisolone ; < 12 months, < 10 kg, 10 mg (2 mL) ; 1 -3 years, 10 - 15 kg, 10 - 15 mg (2 - 3 mL) ; 4 - 5 years, 15 - 20 kg, 15 - 20 mg (3 - 4 mL) ; 6 - 8 years, Dosing & Uses. AdultPediatric. Dosage Forms & Strengths. oral solution. 5mg/5mL; 10mg. At the Children's Hospital of Philadelphia (CHOP) the current standard is to use an initial dose of mg/kg/day ( mg/kg every 6 hours to a maximum of 30 mg. Child Apply every 1—2 hours until controlled then reduce frequency.More than half of these pediatric patients experience an asthma exacerbation each year. Often, the exacerbation requires a short course of oral corticosteroids.
Prednisolone, a liquid formulation of prednisone, is commonly prescribed to these children due to its ease of administration. A short course of prednisolone drastically reduces the need for hospitalization and shortens the length of the exacerbation. Poor adherence due to the bitterness or laxative qualities of prednisolone often limits its effectiveness, however, and careful selection must be made between the available forms prednisolone base versus prednisolone sodium phosphate.
Asthma is the most common cause of hospitalizations and emergency department ED visits for pediatric patients in the Unites States. A 3-year-old child is experiencing an asthma exacerbation—her chest is tight, and she is coughing and wheezing with each breath without responding to inhaled albuterol. A short course of oral prednisolone liquid is prescribed to stop the progression of the episode and the need for hospitalization or an emergency department ED visit.
After picking up the prednisolone from the pharmacy, the mother gives her child the prescribed dose of 5 mL. Almost instantaneously, the child spits out the medicine because of its bitter taste.
Her mother tries repeatedly to give the medication, but fails. There they discover that the wrong formulation of prednisolone was dispensed, which was probably responsible for the failure of home therapy.
The physician had prescribed the generic for Orapred solution prednisolone sodium phosphate , but the pharmacist had dispensed the bitter-tasting prednisolone base generic for Prelone.
Systemic corticosteroids are an essential treatment option for many disease states, especially asthma. These medications reduce the length and severity of asthma exacerbations and reduce the need for hospitalization or ED visits. Although usually prescribed for a 5- to 7-day period, oral corticosteroids are not without adverse effects. The most common adverse effects are the same for the majority of oral corticosteroids and include increased appetite, weight gain, flushed face, and increased acne in adolescents.
Considering that the final amount of prednisolone provided by each formulation is consistent, it would be expected that these adverse effects would be similar for all. The most important physical property of an oral corticosteroid for children is that doses be easily swallowed and retained.
Diminished adherence might be due to the type of prednisolone dispensed to the patient. There is, however, a notable difference between prednisolone sodium phosphate an ester and prednisolone base. The difference is not in the efficacy of each formulation, but rather in the associated taste.
The deciding factor between these products does not reside in the active ingredient, but rather in the inactive ingredients. Sorbitol, a sugar alcohol, is used to increase the palatability of prednisolone sodium phosphate.
The high potency Mission Pharmacal product contains corn syrup fructose , which may also cause diarrhea. Appropriate dispensing starts with proactive measures taken by pharmacists. If a physician orders the product by brand name e.
If a child refuses the sodium phosphate ester of prednisolone, it is recommended that physicians prescribe a dexamethasone tablet, crushed between two spoons and mixed with sugar-free chocolate pudding. Asthma continues to be a major health concern among the pediatric population in the U. Considering the benefits of short bursts of systemic corticosteroid therapy, it is important to ensure that patients tolerate the drug prescribed.
Prednisolone sodium phosphate should be preferentially chosen over prednisone base when prescribing liquid forms of oral corticosteroids.
Risk factors associated with hospital readmission in pediatric asthma. J Pediatr Nurs. Lu S, Kuo DZ. Hospital charges of potentially preventable pediatric hospitalizations. Acad Pediatr. Effect of inhaled corticosteroids on episodes of wheezing associated with viral infection in school age children: randomised double blind placebo controlled trial.
Rachelefsky G. Treating exacerbations of asthma in children: the role of systemic corticosteroids. Hendeles L. Selecting a systemic corticosteroid for acute asthma in young children. J Pediatr. The bad taste of medicines: overview of basic research on bitter taste. Clin Ther. National Heart, Lung, and Blood Institute. Asthma care quick reference: diagnosing and managing asthma.
Updated June Accessed April 13, J Pediatr Gastroenterol Nutr. Receptor-based pharmacokinetic-pharmacodynamic analysis of corticosteroids. J Clin Pharmacol. Featured Issue Featured Supplements. US Pharm. Treatment After picking up the prednisolone from the pharmacy, the mother gives her child the prescribed dose of 5 mL. Corticosteroids and Asthma Systemic corticosteroids are an essential treatment option for many disease states, especially asthma. The Bitterness Barrier The most important physical property of an oral corticosteroid for children is that doses be easily swallowed and retained.
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