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This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and half will receive an inhaled placebo.
Status asthmaticus is an acute exacerbation of asthma that often requires treatment in a pediatric intensive care unit (PICU). Standard therapies for status asthmaticus include corticosteroids and bronchodilators, typically albuterol. Ipratropium bromide is also a bronchodilator, but has a different mechanism of action than albuterol. The addition of Ipraropium to children in the Emergency Room with severe asthma exacerbations improves outcomes, so many PICU doctors treat patients with status asthmaticus with Ipratropium. However, two studies of children hospitalized in the general wards of the hospital (not the PICU) show that the addition of Ipratropium to standard care does not effect clinical outcomes. This study is a first step towards determining in Ipratropium is helpful in PICU patients (like it is in ER patients) or if it not helpful (like it is in general ward patients).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days |
|
| Placebo | Placebo Comparator | Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipratropium | Drug |
|
| |
| 0.9% Sodium Chloride |
| Measure | Description | Time Frame |
|---|---|---|
| Time to q2 Albuterol | In our PICU, status asthmaticus patients are initially treated with continuous nebulization of albuterol. Per a standard assessment/scoring system, the patients are re-assessed each hour. When the patient's symptoms have sufficiently improved, the albuterol is weaned to 2.5mg given every 1hr ("q1hr albuterol") and, subsequently, to 2.5mg given every 2 hours ("q2hr Albuterol"). This outcome will measure the interval between the initiation of continuous albuterol and the second dose of q2hr Albuterol. | typically 12-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PICU LOS (length of stay) | The time interval between admission to the PICU and discharge from the PICU, typically to the general ward. Patients are typically transferred to the general ward when they are receiving albuterol every 3 hours. | This outcome is assessed continually over the course of the study, typically 24-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Dry eyes | Report of dry eyes from the patient, their family or their clinical provider | Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug) |
| Dry mouth |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center) | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9761804 | Background | Qureshi F, Pestian J, Davis P, Zaritsky A. Effect of nebulized ipratropium on the hospitalization rates of children with asthma. N Engl J Med. 1998 Oct 8;339(15):1030-5. doi: 10.1056/NEJM199810083391503. | |
| 11148512 | Background | Craven D, Kercsmar CM, Myers TR, O'riordan MA, Golonka G, Moore S. Ipratropium bromide plus nebulized albuterol for the treatment of hospitalized children with acute asthma. J Pediatr. 2001 Jan;138(1):51-58. doi: 10.1067/mpd.2001.110120. |
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| Drug |
|
|
| Albuterol | Drug | albuterol prescribed by the clinical team per our PICU's "Asthma Carepath" |
|
| corticosteroids | Drug | systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV |
|
|
| Hospital LOS (length of stay) |
The time interval between admission to the hospital and discharge from the hospital. Patients are typically discharged from the hospital when they are receiving albuterol every 4 hours. |
| This outcome is assessed continually over the course of the study, typically 48-120 hours |
Report of dry mouth from the patient, their family or their clinical provider
| Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug) |
| Tremor | Report of tremor from the patient, their family or their clinical provider | Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug) |
| Blurred vision | Report of blurred vision from the patient, their family or their clinical provider | Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug) |
| Urinary retention | Report of urinary retention from the patient, their family or their clinical provider | Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug) |
| Headache | Report of headache from the patient, their family or their clinical provider | Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug) |
| Nausea/abdominal pain | Report of nausea/abdominal pain from the patient, their family or their clinical provider | Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug) |
| 11732951 | Background | Goggin N, Macarthur C, Parkin PC. Randomized trial of the addition of ipratropium bromide to albuterol and corticosteroid therapy in children hospitalized because of an acute asthma exacerbation. Arch Pediatr Adolesc Med. 2001 Dec;155(12):1329-34. doi: 10.1001/archpedi.155.12.1329. |
| 25601985 | Background | Biagini Myers JM, Simmons JM, Kercsmar CM, Martin LJ, Pilipenko VV, Austin SR, Lindsey MA, Amalfitano KM, Guilbert TW, McCoy KS, Forbis SG, McBride JT, Ross KR, Vauthy PA, Khurana Hershey GK. Heterogeneity in asthma care in a statewide collaborative: the Ohio Pediatric Asthma Repository. Pediatrics. 2015 Feb;135(2):271-9. doi: 10.1542/peds.2014-2230. Epub 2015 Jan 19. |
| ID | Term |
|---|---|
| D013224 | Status Asthmaticus |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009241 | Ipratropium |
| D000068600 | Albuterol, Ipratropium Drug Combination |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| D000420 | Albuterol |
| D000305 | Adrenal Cortex Hormones |
| D008775 | Methylprednisolone |
| D011241 | Prednisone |
| D003907 | Dexamethasone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D013259 | Steroids, Fluorinated |
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