Objectives: Analysis of nebulization of hypertonic 3% Saline in Acute Asthma Exacerbation Design, setting and conduct: In this Clinical Trial study and will be done on 169 patients in case and 168 patients in control group, we'll give Saline 3% in addition to standard treatment to the case group and so the control group will receive standard treatment Major Inclusion and Exclusion criteria: Age above 18 years old; Clinically or Para-clinically Asthma History include and History of Cardiovascular Diseases; History of COPD; History of other pulmonary diseases; History of Smoking more than 10 years; Pregnant women; Systolic Blood Pressure less than 100 mmHg exclude Intervention: Saline 3% nebulization to case group outcome measures: Peak Flow Meter parameters will be assessed in two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060526630N2
Registration date:2016-06-21, 1395/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-21, 1395/04/01
Registrant information
Name
Arash Forouzan
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2043
Email address
arash-forouzan@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice challencor for reasearch of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bronchodilator Effect of Nebulized Hypertonic 3% Saline in Asthma Attack
Public title
Bronchodilator Effect of Nebulized Hypertonic 3% Saline in Asthma Attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Acute Asthma Attack with: Age above 15 years old; Clinically or Para-clinically Asthma History Exclusion Criteria: History of Cardiovascular Diseases; History of COPD; History of other pulmonary diseases; History of Smoking more than 10 years; Pregnant women; Systolic Blood Pressure less than 100 mmHg
Age
From 15 years old to 139 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
337
Randomization (investigator's opinion)
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
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Research Assistant, Next to central Building, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2014-05-03, 1393/02/13
Ethics committee reference number
ajums.rec.1393.120
Health conditions studied
1
Description of health condition studied
Acute Exacerbation of Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Forced Expiratory Volume in First Second (FEV1)
Timepoint
Before intervention, 20 minutes after intervention, 40 minutes after intervention, 60 minutes after intervention
Method of measurement
Milliliter with use of Peak Flow Meter
2
Description
Peak Expiratory Flow Rate (PEFR)
Timepoint
Before intervention, 20 minutes after intervention, 40 minutes after intervention, 60 minutes after intervention
Method of measurement
Milliliter with use of Peak Flow Meter
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before Intervention
Method of measurement
Millimeter of Hg
Intervention groups
1
Description
Intervention Group: Salbutamol 2.5mg each 20 minutes via nebulizer Atrovent 2.5mg each 20 minutes via nebulizer Prednisolone 50mg one time by mouth MgSO4 2gr one time IV infusion in 20 minutes, 3% Saline 2.5cc via nebulizer
Category
Treatment - Drugs
2
Description
Control Group: Salbutamol 2.5mg each 20 minutes with nebulizer Atrovent 2.5mg each 20 minutes with nebulizer Prednisolone 50mg by mouth one time MgSO4 2g intravenous infusion in 20 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Arash Forouzan
Street address
Azadi Street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice challencor for reasearch of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor for research, 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 challencor for reasearch of 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 Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Arash Forouzan
Position
Assistant Professor of Emergency Medcine
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
arash-forouzan@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Arash Forouzan
Position
Assistant Professor of Emergency Medcine
Other areas of specialty/work
Street address
Emergency Department - Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
arash-forouzan@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Arash Forouzan
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Emergency Medicine department, Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
arash-forouzan@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)