Goal: analysis of oral Montelukast in acute asthma exacerbation. This clinical trial study will be done on 80 patients in case and control groups, we'll give Montelukast in addition to standard treatment to the case group and so the control group will receive standard treatment and results will be analyzed between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092215446N5
Registration date:2015-12-27, 1394/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-27, 1394/10/06
Registrant information
Name
Hassan Motamed
Name of organization / entity
Emegency Department , Ahvaz Jundishapour University of Medical Sciences , Ahvaz , Iran
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3079
Email address
motamed-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-06-27, 1394/04/06
Expected recruitment end date
2017-01-21, 1395/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of montelukast efficacy on clinical and FEV1/PEFR improvement in acute basthma attack
Public title
Evaluation of montelukast efficacy on clinical and FEV1/PEFR improvement in acute basthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age above 18 years old; documented asthmatic patients with spiropmetry. Exclusion criteria: no response to therapy; use of epinephrine or MgSO4 or IPPV during treatment; patient refuse from continue of treament; lung diseases like ILD; cigarrete smoking.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Research Assistant, Next to central Building, Ahvaz Jundishapur University of Medical Sciences, University town, Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2015-06-27, 1394/04/06
Ethics committee reference number
IR.AJUMS.REC.1394.228
Health conditions studied
1
Description of health condition studied
Acute attack asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Clinical state
Timepoint
Before intervention, 30, 60, 90, 150 minutes after intervention
Method of measurement
Base on alert status, talking, wizing, use of respiratory mu
2
Description
Forced Expiratory Volum in First Secend (FEV1)
Timepoint
Before intervention, 30, 60, 90, 150 minutes after intervention
Method of measurement
Mililiter with use of Peak Flow Meter
3
Description
Peak Expiratory Flow Rate(PEFR)
Timepoint
Before intervention, 30, 60, 90, 150 minutes after intervention
Method of measurement
Mililiter with use of Peak Flow Meter
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before intervention, 30, 60, 90, 150 minutes after intervention
Method of measurement
mmHg
2
Description
Pulse Rate
Timepoint
Before intervention, 30, 60, 90, 150 minutes after intervention
Method of measurement
Rate/Minutes
3
Description
Respiratory Rate
Timepoint
Before intervention, 30, 60, 90, 150 minutes after intervention
Method of measurement
Rate/Minutes
4
Description
Saturation of arterial blood oxygen (SO2 %)
Timepoint
Before intervention, 30, 60, 90, 150minutes after intervention
Method of measurement
Pulse Oximetry
5
Description
Pulsus Paradox
Timepoint
Before intervention, 30, 60, 90, 150 minutes after intervention
Method of measurement
10 mmHg reduction of blood pressure during inspiration
Intervention groups
1
Description
Intervention Group: (N Salbutamol 2.5 mg + N Ipratropium 0.5 mg ) *3 times every 20 min. + 2 tabulate Montolocast 5 mg at 0 min. chew.
Category
Treatment - Drugs
2
Description
Control Group: (N Salbutamol 2.5 mg + N Ipratropium 0.5 mg ) *3 times every 20 min. + 2 tabulate Placebo 5 mg at 0 min. chew.Total Patient at 0, 30, 60, 90,150min. After starting the intervention the PEFR and FEV1 should be measured and registered.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Dr. Hasan Motamed
Street address
Ahvaz Golestan Hospital, Golestan
City
Ahvaz
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Hasan Motamed
Street address
Imam Khomeini Hospital , 24 metri street, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanceller for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Research Assistant, Next to center Building, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanceller for research, Ahvaz Jundishapur 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
Ahvaz Golestan Hospital
Full name of responsible person
Dr. Hasan Motamed
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital, Golestan street, Ahvaz
City
Ahvaz
Postal code
613573318
Phone
+98 61 3374 3079
Fax
Email
Hasan_motamed@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Golestan Hospital
Full name of responsible person
Dr. Hasan Motamed
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital, Golestan street, Ahvaz
City
Ahvaz
Postal code
613573318
Phone
+98 61 3374 3079
Fax
Email
Hasan_motamed@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Golestan Hospital
Full name of responsible person
Dr. Hasan Motamed
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital, Golestan street, Ahvaz
City
Ahvaz
Postal code
613573318
Phone
+98 61 3374 3079
Fax
Email
Hasan_motamed@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)