Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days |
Drug: Ipratropium
Other Names:
Drug: Albuterol
albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"
Drug: corticosteroids
systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV
Other Names:
|
| Placebo Comparator: Placebo Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days |
Drug: 0.9% Sodium Chloride
Other Names:
Drug: Albuterol
albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"
Drug: corticosteroids
systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Time to q2 Albuterol [typically 12-48 hours]
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.
Secondary Outcome Measures
- PICU LOS (length of stay) [This outcome is assessed continually over the course of the study, typically 24-72 hours]
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.
- Hospital LOS (length of stay) [This outcome is assessed continually over the course of the study, typically 48-120 hours]
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.
Other Outcome Measures
- Dry eyes [Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)]
Report of dry eyes from the patient, their family or their clinical provider
- Dry mouth [Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)]
Report of dry mouth from the patient, their family or their clinical provider
- Tremor [Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)]
Report of tremor from the patient, their family or their clinical provider
- Blurred vision [Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)]
Report of blurred vision from the patient, their family or their clinical provider
- Urinary retention [Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)]
Report of urinary retention from the patient, their family or their clinical provider
- Headache [Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)]
Report of headache from the patient, their family or their clinical provider
- Nausea/abdominal pain [Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)]
Report of nausea/abdominal pain from the patient, their family or their clinical provider
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Admission to the PICU
-
Treatment with continuous albuterol via the Asthma Carepath
-
Enrollment occurred within 4 hours of starting continuous albuterol in the PICU
-
Treatment with systemic corticosteroids by the clinical team
Exclusion Criteria:
-
First episode of wheezing that prompted treatment with bronchodilators by medical personnel
-
Prior enrollment in this study
-
Patients with chronic lung disease requiring routine home oxygen use
-
Allergy to inhaled ipratropium or inhaled saline
-
Positive pressure ventilation (via an endotracheal tube or a non-invasive mask [e.g. CPAP (continuous positive airway pressure) or BiPAP])
-
Pregnancy
-
Tracheostomy
-
Age < 2 years
-
Age > 17 years
-
Patient with pulmonary hypertension requiring daily therapy
-
Patient with cyanotic congenital heart disease
-
Cystic fibrosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center) | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- University Hospitals Cleveland Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- IRB #02-16-18