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The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in the emergency room.
Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids.
Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in the emergency room has any benefit on, symptom score, hospitalization rate and time to discharge from emergency room.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the emergency room for acute wheezing.
Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.
Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Budesonide nebulized suspension | Active Comparator | Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times and will not give after 3 doses |
|
| 2- 0.9% saline | Placebo Comparator | Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg/ml budesonide nebules | Drug | Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary index score at 2 to 4 hours | 2 to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital admission rates | 4 hours | |
| Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild. | 4 hours | |
| Respiratory rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C H Razi, MD | Kecioren Education and Training Hospital | Study Director |
| C H Razi, MD | Kecioren Education and Training Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kecioren Education and Training Hospital | Ankara | Kecioren | 06380 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D012135 | Respiratory Sounds |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Saline | Drug | Children will receive 2 ml of saline every 20 minutes for 3 times |
|
|
| 2 hours |
| Oxygen saturation | 2 hours |
| Time to discharge from the Emergency Department to home | 2 to 4 hours |
| Adverse reactions. | 2-5 days |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |