Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus

Status Asthmaticus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872597
• Other study ID #: IRB #02-16-18
• Status: Completed
• Phase: Phase 1
• Start date: September 5, 2016
• Est. completion date: August 16, 2018

Study information

• Verified date: April 2019
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 16, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Status Asthmaticus

Intervention

Drug:
• Ipratropium

• 0.9% Sodium Chloride

• Albuterol
albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"
• corticosteroids
systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV

Locations

Country	Name	City	State
United States	Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Dry mouth	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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
Secondary	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
Secondary	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