deltatrials
Unknown PHASE4 INTERVENTIONAL 2-arm NCT02584738

Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation

Efficacy of Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation. A Randomized Controlled Trial

Sponsor: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Conditions Asthma
Updated 8 times since 2017 Last updated: Nov 30, 2015 Started: Sep 30, 2015 Primary completion: Jan 31, 2016 Completion: Jan 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Asthma, this trial is ongoing. The trial is conducted by Hospital General Naval de Alta Especialidad - Escuela Medico Naval and has accumulated 8 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

The inclusion period of the patients in this research will be on September 2015 to November 2015. Patients are going to be selected by the medical staff on duty in the emergency paediatric service, according to the criteria previously established inclusion and exclusion. Immediately a baseline degree of respiratory distress using PRAM scale and heart rate, respiratory rate, blood pressure and oxygen saturation. While informed consent in which the objective and characteristics of the study will be obtained will be explained. Patients will be randomly assigned one of the two treatments in the Research: standard treatment for moderate to severe asthma attack, according to GINA or standard treatment plus nebulised magnesium sulphate, according to the table of random allocation of treatment. Evaluations were performed after administration of each spray, that is, at 20, 40, 60, 120, 180 and 240 minutes after beginning treatment. The parameters' to evaluate are going to be heart rate, respiratory rate, oxygen saturation, blood pressure and assessment of severity of acute asthma with PRAM scale. The application of nebulized drugs are made in the emergency department of pediatrics by inhalation therapy staff who are also responsible for the preparation of medicines. It is clear that this...

The inclusion period of the patients in this research will be on September 2015 to November 2015. Patients are going to be selected by the medical staff on duty in the emergency paediatric service, according to the criteria previously established inclusion and exclusion. Immediately a baseline degree of respiratory distress using PRAM scale and heart rate, respiratory rate, blood pressure and oxygen saturation. While informed consent in which the objective and characteristics of the study will be obtained will be explained.

Patients will be randomly assigned one of the two treatments in the Research: standard treatment for moderate to severe asthma attack, according to GINA or standard treatment plus nebulised magnesium sulphate, according to the table of random allocation of treatment.

Evaluations were performed after administration of each spray, that is, at 20, 40, 60, 120, 180 and 240 minutes after beginning treatment. The parameters' to evaluate are going to be heart rate, respiratory rate, oxygen saturation, blood pressure and assessment of severity of acute asthma with PRAM scale.

The application of nebulized drugs are made in the emergency department of pediatrics by inhalation therapy staff who are also responsible for the preparation of medicines. It is clear that this staff not participate in the evaluation of patients, which will be performed by the research staff or by medical staff on duty in the pediatric emergency department.

Patients and evaluating physician will not pick out between the two solutions for nebulization not only colour but also smell or other special feature, because the solutions were arranged in two identical syringes. Administered alone at the end of the study treatment is known.

Later the entry or exit of the patient decide, who can be egress to show clinical improvement with decreased severity index PRAM, patients will be graduates of an outpatient treatment according to international guidelines on the management of acute asthma. All initial and outcome data will be recorded in a format of data collection All decisions will be made by patients pediatricians emergency department which will follow patients throughout the study and will have the power to release the study patients to use other interventions that they consider clinically necessary

Status Flow

~Jan 2017 – ~Feb 2018 · 13 months · monthly snapshotRecruiting~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE4

  2. Sep 2025 — Present [monthly]

    Unknown PHASE4

  3. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE4

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE4

    Status: Unknown StatusUnknown

  5. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE4

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE4

  2. Feb 2018 — Jun 2018 [monthly]

    Unknown Status PHASE4

    Status: RecruitingUnknown Status

  3. Jan 2017 — Feb 2018 [monthly]

    Recruiting PHASE4

    First recorded

Sep 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Data source: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations