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Trial record 32 of 150 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT02872597
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Shein, University Hospitals Cleveland Medical Center

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
Status Asthmaticus Drug: Ipratropium Drug: 0.9% Sodium Chloride Drug: Albuterol Drug: corticosteroids 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 5, 2016
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days
Drug: Ipratropium
Other Names:
  • Atrovent
  • Duoneb

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:
  • methylprednisolone
  • prednisone
  • dexamethasone
  • prednisolone

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 Name: Normal saline

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:
  • methylprednisolone
  • prednisone
  • dexamethasone
  • prednisolone




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872597


Locations
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United States, Ohio
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

Publications:
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Responsible Party: Steven Shein, Attending Physician, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02872597     History of Changes
Other Study ID Numbers: IRB #02-16-18
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ipratropium
Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisolone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Albuterol
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents