NCT01515995

Brief Summary

The purpose of this study is to evaluate the effectiveness of nebulized magnesium sulfate as a vehicle for albuterol in children with moderate to severe asthma exacerbation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4 asthma

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

Study Start

First participant enrolled

January 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

February 21, 2019

Completed
Last Updated

February 21, 2019

Status Verified

January 1, 2019

Enrollment Period

3.8 years

First QC Date

January 11, 2012

Results QC Date

December 31, 2018

Last Update Submit

January 29, 2019

Conditions

Asthma

Keywords

Magnesium sulfateChildhood asthmaEmergency department

Outcome Measures

Primary Outcomes (1)

  • Change in Forced Expiratory Volume in One Second (FEV1) %

    Change in forced expiratory volume in one second (FEV1) as measured by bedside spirometry before and after study intervention.

    Baseline and one hour after treatment

Study Arms (2)

Magnesium sulfate group

EXPERIMENTAL

15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour

Drug: Nebulized magnesium sulfate

Normal Saline group

ACTIVE COMPARATOR

15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour

Drug: Nebulized magnesium sulfate

Interventions

Nebulized magnesium sulfateDRUG

15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour Versus 15 mg albuterol in 22 ml of normal saline via nebulizer over one hour

Also known as: Inhaled magnesium sulfate
Magnesium sulfate groupNormal Saline group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients age ≥ seven years
  • Previous diagnosis of asthma or previous episode of wheezing treated with beta-agonist medication
  • Able to complete bedside spirometry
  • FEV1 \< 70% predicted

You may not qualify if:

  • Known allergy to magnesium sulfate
  • Known contra-indication to albuterol
  • Respiratory distress occurring as a result of bedside spirometry
  • History of neuromuscular disease, cardiac disease, renal disease, or underlying chronic lung disease
  • Pregnancy
  • Use of oral steroid medication within 72 hours of presentation
  • Radiographic evidence of pneumonia at presentation
  • Intubation during the current encounter prior to study enrollment
  • Administration of intravenous magnesium sulfate prior to study enrollment
  • Prior participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

AsthmaEmergencies

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mohamed Badawy, MD
Organization
UT Southwestern Medical Center
mohamed.badawy@utsouthwestern.edu
2144567106

Study Officials

  • Mohamed Badawy, MD

    University of Texas Southwestern Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 24, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 21, 2019

Results First Posted

February 21, 2019

Record last verified: 2019-01

Locations

US(1)