Determining the effect of adding oral montelukast to standard treatment in controlling asthma attacks in children
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 90 patients. Blocking was used for randomization.
Settings and conduct
Children with severe asthma attacks referred to Hazrat Masoumeh Hospital in Qom. A double-blind clinical trial, based on the randomized block method. Patients and outcome assessors are not aware of the type of drug allocation of patients.
Participants/Inclusion and exclusion criteria
Children aged 5-13 years with severe acute asthma attack;
Lack of parental consent to participate in the study;
Children suffering from heart, lung, metabolic diseases;
Children under 5 years old and over 13 years old;
History of anti-leukotriene use in the last two weeks;
Children who need intubation for treatment.
Intervention groups
The case group includes children who, in addition to standard treatment, will also receive oral Montelukast from Airocast to control an acute asthma attack.
The control group consists of children who will receive standard treatment plus a placebo provided by Airocast to control asthma attacks.
Main outcome variables
speech status; the position of the patient at the time of the attack; restlessness; number of breaths per minute; use of secondary respiratory muscles; state of consciousness; Lung auscultation during the attack; percentage of oxygen saturation; PEF; heart rate
Measure with, PEF; Vital Signs; Pulse oximetry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220508054776N1
Registration date:2023-11-07, 1402/08/16
Registration timing:prospective
Last update:2023-11-07, 1402/08/16
Update count:0
Registration date
2023-11-07, 1402/08/16
Registrant information
Name
seyed salman moosavynejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3162 5224
Email address
salman.moosavy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-29, 1402/12/10
Expected recruitment end date
2024-04-29, 1403/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding oral Montelukast to standard treatment in controlling of acute asthma attacks in pediatrics
Public title
The effect of oral montelukast in controlling acute asthma attacks in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 5-13 years
Children with an acute asthma attack
Exclusion criteria:
Parents' lack of consent to participate in the study
The child's heart, lung, and metabolic diseases
Children under 5 years old and over 13 years old
History of anti-leukotriene use in the last two weeks
Children who need intubation for treatment
Age
From 5 years old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website
Blinding (investigator's opinion)
Double blinded
Blinding description
The special codes created by the website are assigned to the patients and provided to the therapists, and neither the patient nor the therapist knows whether the oral medication that is given to the patient in addition to the standard treatment is Montelukast or a placebo, both medications. It is produced in tablet form by Airocast.
Placebo
Used
Assignment
Parallel
Other design features
Addition of oral montelukast to the standard treatment of acute asthma attack in children
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Qom,Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2022-05-10, 1401/02/20
Ethics committee reference number
IR.MUQ.REC.1401.043
Health conditions studied
1
Description of health condition studied
Acute asthma attack
ICD-10 code
J45.50
ICD-10 code description
Severe persistent asthma
Primary outcomes
1
Description
PEF
Timepoint
PEF measurement on arrival and 6 hours later
Method of measurement
Picoflowmeter device
2
Description
The effect of adding oral montelukast to standard treatment on patient's blood oxygen
Timepoint
Upon arrival and 6 hours later
Method of measurement
with pulse oximeter
Secondary outcomes
1
Description
Effect of adding oral montelukast to standard treatment on vital signs
Timepoint
Upon arrival and 6 hours later
Method of measurement
Examination of the patient by a doctor
2
Description
Effect of adding oral montelukast to standard treatment on respiratory distress
Timepoint
Upon arrival and 6 hours later
Method of measurement
Examination of the patient by a doctor
Intervention groups
1
Description
Case group: Children aged 13-5 years will receive 5 mg of oral memontelocut as a single dose in addition to standard primary treatment.
Category
Treatment - Drugs
2
Description
Control group:2. The control group consists of children who will receive standard treatment along with 5 mg of placebo provided by Airocast company to control asthma attacks..