evaluation of effect of oral montelukast on pulmonary function improvment
Design
In our research ,140 patients who have entry ceriterion,and coming to sari’s
Emam khomeini hospital,coding in basis of table of randum numbers.they divide two group intervention and control.
Settings and conduct
Our research will be done in sari’s Emam khomein hospital.It is be double blind,researcher and events evaluater and patients kept blind.
Participants/Inclusion and exclusion criteria
Known cases of asthma 18 to 65 years old,Who addmit with impression of asthma exacerbatin come into our research.Intubation,other pulmonary disease such as pneumonia,pregnancy and lactation,more than 20 pack/years smoking,phanytoein?phenobarbital and rifampin user’s,hypersansitivity to montelukast are exclude criteria.
Intervention groups
The patients that take oral montelukast and approved treatment of asthma exacerbation, other group,patients thah take placebo tablet in additon to approved asthma exacerbation treatment.
Main outcome variables
Patient’s symptom,physicsl exam.pulmonary function test (FEV1) ,PEFR.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171227038108N1
Registration date:2018-01-28, 1396/11/08
Registration timing:registered_while_recruiting
Last update:2018-01-28, 1396/11/08
Update count:0
Registration date
2018-01-28, 1396/11/08
Registrant information
Name
Masoud Alyiali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3335 0672
Email address
masoudaliyali@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral Montelukast on lung function and clinical symptoms of asthma exacerbation in Imam Hospital`s patient
Public title
effect of montelukast in athma exacerbation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 -65 years old
Known case of asthma
Impersion of asthma exacerbation at time of addmision
Exclusion criteria:
Intubation at time of addmision
Other cause of pulmunary disease for example pneumonia
Pregnancy and lactation
History of hypersensitivity to montelukast
Drug history of phenytoin,rifampin,phenobarbital
History of smoking more than 20 pack/years
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Patients to be coding in bases of Table of random number,then divide to two groups.Control and intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Analyzer coding patients in basis of table of randum numbers.patients,research fellow and avaluator of events kept to blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Siences
Street address
Amirmazandarani Blvd,sari Town
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2017-08-20, 1396/05/29
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1396.3092
Health conditions studied
1
Description of health condition studied
Asthma exacerbation
ICD-10 code
J45.41
ICD-10 code description
Moderate persistent asthma with (acute) exacerbation
Primary outcomes
1
Description
Pulmonary function tast
Timepoint
1,3,5 day’s of addmition
Method of measurement
spirometry,peak flowmetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients that treat with montelukast 10 milligram overnight and asthma exacerbation.
Category
Treatment - Drugs
2
Description
Control group: The patients that take placebo tablet in addition to approved asthma exacerbation treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari’s Emam hospital
Full name of responsible person
Mahdie Fattahi
Street address
Amirmazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0672
Fax
+98 11 3335 0672
Email
fattahimahdie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology dept of Mazandaran University Of Medical Science
Full name of responsible person
Majid saeidi
Street address
Mo’alem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3082
Fax
+98 11 3326 1244
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology dept of Mazandaran University Of Medical Science
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
Mazandaran University of Medical Science
Full name of responsible person
Mahdie Fattahi
Position
Internal rasident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
15 khordad,Sari Town
City
Sari
Province
Mazandaran
Postal code
4818891971
Phone
+98 11 3340 8192
Fax
+98 11 3340 5772
Email
fattahimahdie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Madoud Aliyali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amirmazandarani Blvd,Emam hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0671
Fax
+98 11 3335 0672
Email
Masoud_aliyali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Mahdie Fattahi
Position
Internal rasident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
15khordad,Sari Town
City
Sari
Province
Mazandaran
Postal code
4818891971
Phone
+98 11 3340 8192
Email
fattahimahdie@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
patient dissatisfaction
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
demografic table and questionnaire
When the data will become available and for how long
spring 97
To whom data/document is available
Medical students
Under which criteria data/document could be used
Thesis
From where data/document is obtainable
Emam hospital,Internal group
What processes are involved for a request to access data/document