Trial Outcomes & Findings for Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation (NCT NCT01515995)

NCT ID: NCT01515995

Last Updated: 2019-02-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline and one hour after treatment
• Results posted on: 2019-02-21

Participant Flow

Participant milestones

Measure	Magnesium Sulfate Group 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour Nebulized magnesium sulfate: 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	Normal Saline Group 15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour Nebulized magnesium sulfate: 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
Overall Study STARTED	25	25
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma Exacerbation

Baseline characteristics by cohort

Measure	Magnesium Sulfate Group n=22 Participants 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour Nebulized magnesium sulfate: 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	Normal Saline Group n=21 Participants 15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour Nebulized magnesium sulfate: 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	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.8 years n=5 Participants	10.8 years n=7 Participants	10.8 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	21 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and one hour after treatment

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

Outcome measures

Measure	Magnesium Sulfate Group n=22 Participants 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour Nebulized magnesium sulfate: 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	Normal Saline Group n=21 Participants 15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour Nebulized magnesium sulfate: 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
Change in Forced Expiratory Volume in One Second (FEV1) %	3.6 Percentage of FEV1 Interval 0.9 to 6.3	5 Percentage of FEV1 Interval 1.7 to 8.4

Adverse Events

Magnesium Sulfate Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Normal Saline Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Magnesium Sulfate Group n=25 participants at risk 15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour Nebulized magnesium sulfate: 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	Normal Saline Group n=25 participants at risk 15 mg albuterol in 22 ml of normal saline solution via nebulizer over one hour Nebulized magnesium sulfate: 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
Respiratory, thoracic and mediastinal disorders Burning sensation in the nose	16.0% 4/25	0.00% 0/25

Additional Information

Mohamed Badawy, MD

UT Southwestern Medical Center

Phone: 2144567106

Email: mohamed.badawy@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place