Revisions for Second Line-Acute Asthma | Registro Público Cubano de Ensayos Clínicos

--- 9 July 2020 - 1:52pm by Gladys
+++ 24 March 2023 - 7:02am by Gladys
 Injections, Intravenous
 Administration, Intravenous
 Single Dose
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+/10/21
-/07/09
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Revision of 24 March 2023 - 7:02am:

Second Line-Acute Asthma

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

SeLAA

Scientific title:

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

Acronym of Scientific Title:

SeLAA

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Autonomous Service Antonio Patricio de Alcala University Hospital (SAHUAPA)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Elias

Midle name:

Ibrahim

Last name:

Kassisse El Hage

Medical Specialty :

Pediatrician specialist II pediatric pulmonologist

Affiliation:

Herminda Martin Clinical Hospital

Postal address:

Francisco Ramirez avenue 10

City:

Chillan

Country:

Chile

Zip Code:

3780000

Telephone:

+56-947893177

Email address:

ekassisse@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Venezuela

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

01/04/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Acute asthma

Health condition(s) code:

Asthma

Bronchial Diseases

Lung Diseases, Obstructive

Lung Diseases

Respiratory Tract Diseases

Respiratory Hypersensitivity

Hypersensitivity, Immediate

Hypersensitivity

Immune System Diseases

Environmental Illness

Intervention(s):

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. Group II. Magnesium sulfate (MgSO4)(experimental): Single intravenous dose calculated at 50 mg per Kg of weight

Intervention code:

Aminophylline

Magnesium Sulfate

Infusions, Intravenous

Injections, Intravenous

Administration, Intravenous

Single Dose

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

2 years

Maximum age:

12 years

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:

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

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Single Blind

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

131

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Elias

Middle Name:

Ibrahim

Last Name:

Kassisse El Hage

Specialty:

Pediatrician specialist II pediatric pulmonologist

Affiliation:

Herminda Martin Clinical Hospital

Postal Address:

Francisco Ramirez Avenue 10

City:

Chillan

Country:

Chile

Zip Code:

3780000

Telephone:

+56 42 2586400

Email :

ekassisse@gmail.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Elias

Middle Name:

Ibrahim

Last Name:

Kassisse El Hage

Specialty:

Pediatrician specialist II pediatric pulmonologist

Affiliation:

Herminda Martin Clinical Hospital

Postal Address:

Francisco Ramirez Avenue 10

City:

Chillan

Country:

Chile

Zip Code:

3780000

Telephone:

+56-422586400

Email :

ekassisse@gmail.com

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

131

Study completion date:

31/08/2018

Date of available results:

31/07/2020

Date of first publication:

28/08/2020

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000324

Date of Registration in Primary Registry:

09/07/2020

Record Verification Date:

2020/10/21

Next update date:

2021/10/21

Link to the spanish version:

Click here

Registered Trials

Registration process

Second Line-Acute Asthma

About the RPCEC

Useful resources