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NCT Number: NCT02872597

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

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.

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Key information

Conditions

Status Asthmaticus Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center)

Cleveland, Ohio, 44106, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipratropium

Drug

Other names: Atrovent, Duoneb

0.9% Sodium Chloride

Drug

Other names: Normal saline

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

Other names: methylprednisolone, prednisone, dexamethasone, prednisolone

Primary outcomes

  1. Time to q2 Albuterol

    Time frame: 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 outcomes

  1. PICU LOS (length of stay)

    Time frame: 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.

  2. Hospital LOS (length of stay)

    Time frame: 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 outcomes

  1. Dry eyes

    Time frame: 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

  2. Dry mouth

    Time frame: 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

  3. Tremor

    Time frame: 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

  4. Blurred vision

    Time frame: 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

  5. Urinary retention

    Time frame: 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

  6. Headache

    Time frame: 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

  7. Nausea/abdominal pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2016
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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