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Trial record 32 of 151 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

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 19, 2016
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE September 5, 2016
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02872597 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 18, 2016)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus
Official Title  ICMJE A Phase I, Single Center, Placebo-Controlled, Blinded Pilot Study of Ipratropium Bromide in Children Admitted to the Intensive Care Unit With Status Asthmaticus
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Status Asthmaticus
Intervention  ICMJE
  • Drug: Ipratropium
    Other Names:
    • Atrovent
    • Duoneb
  • 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
Study Arms  ICMJE
  • Experimental: Treatment
    Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days
    Interventions:
    • Drug: Ipratropium
    • Drug: Albuterol
    • Drug: corticosteroids
  • Placebo Comparator: Placebo
    Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days
    Interventions:
    • Drug: 0.9% Sodium Chloride
    • Drug: Albuterol
    • Drug: corticosteroids
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 16, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02872597
Other Study ID Numbers  ICMJE IRB #02-16-18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Steven Shein, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospitals Cleveland Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP