Second Line-Acute Asthma

Usefulness of second-line agents in children with acute asthma. Randomized study of clinical efficacy - SeLAA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000324

Enrollment

131

Registered

2020-07-09

Start date

2017-04-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute asthma

Interventions

Group I. Aminophylline (control): An initial loading dose calculated at 5 mg per Kg of weight intravenous followed by a continuous infusion calculated at 1mg per Kg per hour for the following 3 hours.

Aminophylline

Magnesium Sulfate

Infusions, Intravenous

Injections, Intravenous

Administration, Intravenous

Single Dose

Eligibility

Sex/Gender

All

Age

2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age greater than or equal to 2 years and less than or equal to 12 years 2. Previous diagnosis of asthma (more than 3 exacerbations that had improved with the use of salbutamol) 3.Consult for acute exacerbation of asthma

Exclusion criteria

Exclusion criteria: 1.Children with chronic cardiac, immunological, pulmonary diseases other than asthma and hematology 2. Previous hospitalizations in the last 4 weeks for any reason 3.If they had received either of the medications under study

Design outcomes

Primary

Measure	Time frame
1. Asthma Severity: (Changes in the Asthma Severity Scale (ASS) score with respect to the baseline value.) Measurement time: baseline and, 180 minutes after the intervention . 2.Oxygen saturation (Percentage change from the baseline until final value). Measurement time: at baseline and, 180 minutes after intervention.	—

Secondary

Measure	Time frame
1.Rate of hospitalized (Percentage of hospitalized patients). Measurement time: 180 minutes after intervention: 2. Need to transfer to the intensive care unit (Percentage of patients who required to be transferred to the intensive care units). Measurement time: 180 minutes after intervention. 3. Adverse effects (Percentage of patients with any reaction attributable to the use of medications). Measurement time: 180 minutes after intervention. 4.Need to use another type of medication (Percentage of patients required to use a third medication, that is, what percentage of those who initially used magnesium sulfate that they should have received aminophylline and what percentage of those who initially received aminophylline should have used magnesium sulfate). Measurement time: 180 minutes after intervention	—

Measure

Time frame

1.Rate of hospitalized (Percentage of hospitalized patients). Measurement time: 180 minutes after intervention: 2. Need to transfer to the intensive care unit (Percentage of patients who required to be transferred to the intensive care units). Measurement time: 180 minutes after intervention. 3. Adverse effects (Percentage of patients with any reaction attributable to the use of medications). Measurement time: 180 minutes after intervention. 4.Need to use another type of medication (Percentage of patients required to use a third medication, that is, what percentage of those who initially used magnesium sulfate that they should have received aminophylline and what percentage of those who initially received aminophylline should have used magnesium sulfate). Measurement time: 180 minutes after intervention

—

Countries

Venezuela

Contacts

Public ContactElias Kassisse El Hage

Herminda Martin Clinical Hospital

ekassisse@gmail.com

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026