Oral Prednisolone Dosing in Children Hospitalized With Asthma
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| ClinicalTrials.gov Identifier: NCT00257933 |
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Recruitment Status :
Completed
First Posted : November 24, 2005
Results First Posted : August 11, 2010
Last Update Posted : December 31, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: Prednisolone high dose Drug: Prednisolone lower dose | Phase 4 |
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. At the Children's Hospital of Philadelphia (CHOP) the current standard is to use an initial dose of 4.0 mg/kg/day (1.0 mg/kg every 6 hours to a maximum of 30 mg/dose) although many other pediatric hospitals use a 2.0 mg/kg/day dose (1.0 mg/kg every 12 hours to a maximum of 30 mg/dose). 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 (1.0 mg/kg (max 30 mg) every 6 hours), or the lower dose (1.0 mg/kg (max 30 mg) every 12 hours and placebo doses at 6 hour intervals in between) for the first 48 hours of hospitalization. Once 48 hours has past, all patients still hospitalized will receive 1.0 mg/kg (max 30 mg) every 12 hours for the duration of hospitalization. Approximately 156 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 (FEV1), improvement in peak expiratory flows (PEF), improvement in asthma symptom scores, and rate of relapse after discharge.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 152 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Oral Prednisolone Dosing in Children Hospitalized With Asthma |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | November 2006 |
| Actual Study Completion Date : | November 2006 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
High dose prednisolone
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Drug: Prednisolone high dose
4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose)
Other Names:
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Experimental: 2
Lower dose prednisolone alternating with placebo
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Drug: Prednisolone lower dose
2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo
Other Names:
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- Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered [ Time Frame: Median time from loading dose to home dose of albuterol ]
- Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order [ Time Frame: Mean time from writing admit order until discharge order ]
- Time Spent in Each Severity Level of the Asthma Care Pathway [ Time Frame: Time spent in each severity level of pathway ]
- The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups [ Time Frame: Every 4 hours during hospitalization ]
- Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups [ Time Frame: Every 4 hours during hospitalization ]
- Rate of Relapse Between Treatment Groups [ Time Frame: 2 weeks after hospitalization ]
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| Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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.gov identifier (NCT number): NCT00257933
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Joseph J Zorc, MD | Children's Hospital of Philadelphia |
| Responsible Party: | Joseph J. Zorc, M.D., The Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00257933 |
| Other Study ID Numbers: |
2005-9-4377 |
| First Posted: | November 24, 2005 Key Record Dates |
| Results First Posted: | August 11, 2010 |
| Last Update Posted: | December 31, 2010 |
| Last Verified: | December 2010 |
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Corticosteroids Treatment Pediatric |
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Prednisolone hemisuccinate |
Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |