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The effect of inhaled beclomethasone with or without montelukast in the control of pediatric persistent asthma

Protocol summary

Summary
Purpose: The effect of the oral montelukast compared to the inhaled beclomethasone on the control of pediatric persistent asthma Inclusion criteria: Children aged 6-10 years with persistent asthma symptoms. (The criterion for asthma diagnosis was based on GINA considering the history, clinical examination and respiratory function test). Exclusion criteria: Children with lung infections, any underlying illness (simultaneous cardiac disease, antihistamine use, having any illness and taking other medications). Population: Children with persistent asthma, referring to Amirkola Children's Hospital in 2016 Allocation of samples will do as block randomization with foursome blocks in two groups: ABBA/BAAB/BBAA/AABB/ABAB/ABBA/BAAB/BBAA/AABB/ABAB/ABBA/BAAB/BBAA/AABB/ABAB/ABBA/BAAB/BBAA/AABB/ABAB/ Also, test and its interpretation will perform by the relevant technician and master, respectively as single blind. Sample size: Considering the admission of 82, 45% for both groups, 40 patients per group and totally 80 children. Secondary outcomes: Quality of night sleep and absence from school. Primary outcome: Improvement in FEV1 values Intervention: Patients of one group will receive 100 micrograms of inhaled beclomethasone three times a day with 5 mg of montelukast tablets daily, while another group only will receive 100 micrograms of inhaled beclomethasone three times a day. Before and 3 months after treatment, the FEV1, IgE, eosinophilia, night sleep quality (sleep deprivation) and absence from school will be recorded. At the end of the treatment for two groups in the questionnaire (by one person) and also in the third month, the probable complications of montelukast (headache, diarrhea, nausea and hives) will be recorded. The FEV1 response to treatment is greater than 80%.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092036286N1
Registration date: 2017-10-17, 1396/07/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Dr Athena Modanlu
Name of organization / entity
Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
a.modanlu@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice- Chancellor for Research Technology Affairs of Babol University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhaled beclomethasone with or without montelukast in the control of pediatric persistent asthma
Public title
Effect of beclomethasone in the control of pediatric asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pediatrics aged 6 to 10 years; Pediatrics with persistent asthma symptoms; referred to the Center during the study; Exclusion criteria: Pediatrics with lung infections; Pediatrics any underlying illness such as simultaneous cardiac disease; Antihistamine use; Having any illness; Taking other medications;
Age
From 6 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.
City
Babol
Postal code
4717647745
Approval date
2017-08-27, 1396/06/05
Ethics committee reference number
MUBABOL.HRI.REC.1396.38

Health conditions studied

1

Description of health condition studied
Pediatric Persistent Asthma
ICD-10 code
J45.0
ICD-10 code description
Predominantly allergic asthma

Primary outcomes

1

Description
FEV1
Timepoint
Before and 3 months after treatment
Method of measurement
With spirometry

Secondary outcomes

1

Description
Go to school
Timepoint
At the end of the treatment
Method of measurement
Take report from parent and completion in the questionnaire

2

Description
Night sleep quality (sleep deprivation)
Timepoint
At the end of the treatment
Method of measurement
Take report from parent and completion in the questionnaire

Intervention groups

1

Description
First group: Patients of one group will receive 100 micrograms of inhaled beclomethasone three times a day with 5 mg of montelukast tablets daily.
Category
Treatment - Drugs

2

Description
Second group: Patients only will receive 100 micrograms of inhaled beclomethasone three times a day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirkola Children’s Hospital, Babol University of Medical Sciences
Full name of responsible person
Dr Athena Modanlu
Street address
Amirkola Children’s Hospital, Emam Ave, Amirkola, Babol, Mazandaran Province, IR Iran
City
Amirkola- Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences
Full name of responsible person
Dr Aliakbar Moghaddamnia
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street, Babol, Mazandaran Province, IR Iran.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of
Full name of responsible person
Dr Iraj Mohammadzadeh
Position
Pediatric clinical Immunology & allergy
Other areas of specialty/work
Street address
Amirkola Children’s Hospital, Emam Ave, Amirkola, Babol, Mazandaran Province, IR Iran.
City
Amirkola, Babol
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
irjmoh2000@yahoo.com; faezeaghajanpour@yahoo.com;
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Non-Communicable Pediatric Diseases Research Center, Health Research Institute, Babol University of
Full name of responsible person
Dr Iraj Mohammadzadeh
Position
Pediatric clinical Immunology & allergy
Other areas of specialty/work
Street address
Amirkola Children’s Hospital, Emam Ave, Amirkola, Babol, Mazandaran Province, IR Iran.
City
Amirkola, Babol
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
irjmoh2000@yahoo.com; faezeaghajanpour@yahoo.com;
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Amirkola Children’s Hospital, Babol University of Medical Sciences
Full name of responsible person
Dr Athena Modanlu
Position
Pediatric Assistant
Other areas of specialty/work
Street address
Amirkola Children’s Hospital, Emam Ave, Amirkola, Babol, Mazandaran Province, IR Iran
City
Amirkola- Babol
Postal code
4731741151
Phone
+98 11 3234 6963
Fax
+98 11 3234 6963
Email
a.modanlu@gmail.com; faezeaghajanpour@yahoo.com;
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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