Protocol summary

Summary
This study aim to Compare the efficacy of Nebulized Salbutamol and Furosemide versus Salbutamol alone on Clinical Severity and Peak Expiratory Flow Rate in Acute Reactive Airway Disease. Eligible 18-55 year old Patients with reactive airway disease(RAD) were randomly divided into intervention and control groups .Patients received,5 mg of salbutamol and 40 mg of furosemide nebulization in intervention group and 5 mg of salbutamol and 2cc of distilled water nebulization in control group.Severity of the RAD was estimated before intervention and 45 minutes of intervention in both.Peak expiratory flow meter(PEFR) was estimated before intervention and at 15, 30 and 45 minutes later.Finally,two groups were compared in terms of the severity of the RAD and PEFR before and at mentioned time after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201272782N2
Registration date: 2013-08-18, 1392/05/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Kambiz Masoumi
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 9166
Email address
kami_masoumi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2012-04-04, 1391/01/16
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Nebulized Salbutamol and Furosemide versus Salbutamol alone on Clinical Severity and Peak Expiratory Flow Rate in Acute Reactive Airway Disease
Public title
furosemide nebulization efficacy in acute reactive airway disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients 18-55 years old with clinical manifestation of acute recative airway disease presenting in emergency department Exclsion criteria:Onset of symptoms more than 10 hours;smoking more than 10 pack/year; associated acute medical problem; pregnancy; nebulization with B-agonist during last hours.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ground Floor, IT & Research assistance centre, College complex
City
Ahvaz
Postal code
61357-15794
Approval date
2011-06-27, 1390/04/06
Ethics committee reference number
ETH-329

Health conditions studied

1

Description of health condition studied
Acute Reactive Airway Disease
ICD-10 code
j45
ICD-10 code description
chronic obstructive pulmonary disease

Primary outcomes

1

Description
Acute Reactive Airway Didease Severity
Timepoint
Before and 45 minutes after intervention
Method of measurement
American Thoracic Society definition

2

Description
Peak Expiratory Flow Rate
Timepoint
Before and 15,30 nd 45 minutes after intervention
Method of measurement
Peak flow meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention:nebulization of 5 mg salbutamol and 40 mg furesmide for 15 minutes.
Category
Treatment - Drugs

2

Description
Control:nebulization of 5 mg salbutamol and 2 cc sterile water for 15 minutes
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Kambiz Masoumi
Street address
Emergency Medicine Department, Emergency Ward, Imam Khomeini Hospital, Azadegan Avenue
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Siences
Full name of responsible person
Mostafa Feghhi(Deputy Director of Research)
Street address
Ground Floor, IT & Research assistance centre, College complex
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Siences
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 Science
Full name of responsible person
Kambiz Masoumi
Position
Emergency Medicine specialist, assistant professor
Other areas of specialty/work
Street address
Emergency Department, Imam khomeini hospital, Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61 1222 9166
Fax
Email
kami_masoumi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Emergency Medicine Department
Full name of responsible person
Kambiz Masoumi
Position
Emergency Medicine Specialist, Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Imam khomeini hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 9166
Fax
Email
kami_masoumi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
kambiz Masoumi
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Imam khomeini hospital، Azadegan Avenue
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 9166
Fax
Email
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
empty
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