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

NCT02872597 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-04-18

No results posted yet for this study

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.

Conditions

  • Status Asthmaticus

Interventions

DRUG

Ipratropium

DRUG

0.9% Sodium Chloride

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

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-05
Primary Completion
2018-08-15
Completion
2018-08-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02872597 on ClinicalTrials.gov