Clinical trial NCT02872597: Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus
Official title: A Phase I, Single Center, Placebo-Controlled, Blinded Pilot Study of Ipratropium Bromide in Children Admitted to the Intensive Care Unit With Status Asthmaticus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Status Asthmaticus
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Time to q2 Albuterol
timeFrame: typically 12-48 hours
Secondary outcomes:
measure: PICU LOS (length of stay)
timeFrame: This outcome is assessed continually over the course of the study, typically 24-72 hours
measure: Hospital LOS (length of stay)
timeFrame: This outcome is assessed continually over the course of the study, typically 48-120 hours
Other outcomes:
measure: Dry eyes
timeFrame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
measure: Dry mouth
timeFrame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
measure: Tremor
timeFrame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
measure: Blurred vision
timeFrame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
measure: Urinary retention
timeFrame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
measure: Headache
timeFrame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
measure: Nausea/abdominal pain
timeFrame: Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)
Locations:
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)
state: Ohio
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.