NCT02872597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

September 5, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

August 16, 2016

Last Update Submit

April 17, 2019

Conditions

Status Asthmaticus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • PICU LOS (length of stay)

    This outcome is assessed continually over the course of the study, typically 24-72 hours

  • Hospital LOS (length of stay)

    This outcome is assessed continually over the course of the study, typically 48-120 hours

Other Outcomes (7)

  • Dry eyes

    Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)

  • Dry mouth

    Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)

  • Tremor

    Adverse effects will be assessed 4-6hrs after each administration of study drug (and prior to the next administration of study drug)

  • +4 more other outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days

Drug: IpratropiumDrug: AlbuterolDrug: corticosteroids

Placebo

PLACEBO COMPARATOR

Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days

Drug: 0.9% Sodium ChlorideDrug: AlbuterolDrug: corticosteroids

Interventions

IpratropiumDRUG
Also known as: Atrovent, Duoneb
Treatment
0.9% Sodium ChlorideDRUG
Also known as: Normal saline
Placebo
AlbuterolDRUG

albuterol prescribed by the clinical team per our PICU's "Asthma Carepath"

PlaceboTreatment
corticosteroidsDRUG

systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV

Also known as: methylprednisolone, prednisone, dexamethasone, prednisolone
PlaceboTreatment

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

Related Publications (4)

  • 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. doi: 10.1056/NEJM199810083391503.

    PMID: 9761804BACKGROUND

  • 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. doi: 10.1067/mpd.2001.110120.

    PMID: 11148512BACKGROUND

  • 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. doi: 10.1001/archpedi.155.12.1329.

    PMID: 11732951BACKGROUND

  • 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.

    PMID: 25601985BACKGROUND

MeSH Terms

Conditions

Status Asthmaticus

Interventions

IpratropiumAlbuterol, Ipratropium Drug CombinationSodium ChlorideSaline SolutionAlbuterolAdrenal Cortex HormonesMethylprednisolonePrednisoneDexamethasonePrednisolone

Condition Hierarchy (Ancestors)

AsthmaBronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingEthanolaminesAmino AlcoholsAlcoholsAminesPhenethylaminesEthylaminesDrug CombinationsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

September 5, 2016

Primary Completion

August 15, 2018

Study Completion

August 16, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)