Investigating the effect of standard dose of Albuterol nebulizer, low dose of Albuterol nebulizer with Ipratropium bromide and Albuterol spray on the QT interval in children with moderate to severe asthma.
Determination of the effect of standard dose of Albuterol nebulizer, low dose of Albuterol nebulizer with Ipratropium bromide and Albuterol spray on the QT interval in children with moderate to severe asthma.
Design
The clinical trial with two groups (intervention and control), pragmatic, one-blind, randomized
Settings and conduct
The aim of this study was to investigate the effect of Albuterol on the QT interval in children with moderate to severe asthma in specialty and postgraduate specialty clinic of Heshamateyeh Hospital in Sabzevar city. In this study, participants will be unaware of how to group. Children are randomly assigned to the 3 intervention groups. The response to treatment is evaluated using Electrocardiography at the beginning of the study (before the intervention) after the end of the third treatment and 4 hours after the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 6 months to 15 years Children with moderate to severe asthma or pulmonary obstructive disorder are more than 6 months old Children whose forced Expiratory Volume in First Second (FEV1) is less than 80%.
Exclusion criteria: Children with heart and kidney disease Children who have received Albuterol treatment for less than 30 days. Children who have used Systemic Corticosteroids in the last week.
Intervention groups
First intervention group: Patients use a standard dose of inhaler Albuterol (15 mg/kg, maximal 2.5 mg) twice every 20 minutes to 3 times. Second intervention group: Patients use a combination of low dose Albuterol (0.075 mg/kg, maximal 2.5 mg) and Ipratropium bromide (250 μg) twice every 20 minutes to 3 times. Third intervention group: Patients use an inhaled Albuterol (90 micrograms/kg) twice every 20 minutes to 3 times.
Main outcome variables
QT interval in the electrocardiogram
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181006041252N5
Registration date:2019-01-04, 1397/10/14
Registration timing:registered_while_recruiting
Last update:2019-01-04, 1397/10/14
Update count:0
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
Mohammad Sahebkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8337
Email address
sahebkarm@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-19, 1397/08/28
Expected recruitment end date
2019-01-18, 1397/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of standard dose of Albuterol nebulizer, low dose of Albuterol nebulizer with Ipratropium bromide and Albuterol spray on the QT interval in children with moderate to severe asthma.
Public title
Investigating the effect of standard dose of Albuterol nebulizer, low dose of Albuterol nebulizer with Ipratropium bromide and Albuterol spray on the QT interval in children with moderate to severe asthma.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6 months to 15 years
Children with moderate to severe asthma or pulmonary obstructive disorder are more than 6 months old
Children whose forced Expiratory Volume in First Second (FEV1) is less than 80%
Exclusion criteria:
Children with heart and kidney disease
Children who have received Albuterol treatment for less than 30 days.
Children who have used Systemic Corticosteroids in the last week
Age
From 6 months old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted based on a permutation block, Accordingly, 27 blocks were allocated to patients, in each block, 3 were from following groups, treatment group A, B, and C. Eventually, after completion of the blocks, group A was treated with a standard dose of Albuterol nebulizer, group B was treated with low dose of Albuterol nebulizer with Ipratropium bromide, and group C was treated with albuterol spray.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each person will be assigned a study code A, B, and C, which will only be known to the researcher of the type of groups. The participants are unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.MEDSAB.REC.1397.062
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
QT interval in the electrocardiogram
Timepoint
Electrocardiography (ECG) is performed at the beginning of the study (before the intervention), after the end of the third treatment and 4 hours after the treatment.
Method of measurement
Electrocardiography (ECG)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients use a standard dose of inhaler Albuterol (15 mg/kg, maximal 2.5 mg) twice every 20 minutes to 3 times.
Category
Treatment - Drugs
2
Description
Intervention group: Patients use a combination of low dose Albuterol (0.075 mg/kg, maximal 2.5 mg) and Ipratropium bromide (250 μg) twice every 20 minutes to 3 times.
Category
Treatment - Drugs
3
Description
Intervention group: Patients use an inhaled Albuterol (90 micrograms/kg) twice every 20 minutes to 3 times.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatiyeh hospital
Full name of responsible person
Raziyeh Salehabadi
Street address
Heshamatiyeh Hospital, Asadabady Ave., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1014
Email
raziesalehabadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
ِDr. Alireza Asadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
dralirezaasadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
ِِDr. Alireza Asadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
dralirezaasadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Raziyeh Salehabadi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
raziesalehabadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available