Adult patientsolder than 18 years old presenting to the emergency department of Imam Reza hospital with acute severe asthma attack 18 include in the study and they randomly assign to case and control group. For all the patients before the treatment, PEFR is measured by a hanheld peak flow meter and respiratory rate, Pulse rate and O2 saturation are measured too and the patients will be asked to rate their severity of dyspnea based on a numeric rating scale from 1 to 10.
The standard asthma treatment is given to two groups (The standard treatment includes 2.5 mg Salbutamol with 0.5mg Atrovent through nebulizer each 20 min until three dose plus 300mg Hydrocortizon). In the case group, after second dose of Salbutamol, 250mg Aminophylin with Concentration 25ml/mg is prescribed through nebulizer and for the control group we give Distilled water is through nebulizer instead. After 20 min for both groups the thrid dose of salbutamol and atrovent is give (ncontinue of the standard treatment). So both groups are treated by 3 dose of nebulizes salbutamol and atrovent every 20 min and after the second dose of salbutamol, the case group are administered nebulized aminophyline while the control group receive distilled water as placebo.
For all the patients at the end of the first hour of treatment, PEFR is measured by a hanheld peak flow meter and respiratory rate, Pulse rate and O2 saturation are measured too. The patients will be asked to rate their severity of dyspnea again. It is also documented if the patient became intubated during the 6 hours after treatment and if he/she is admitted to the hospital. Improving in PEFR and hospital admission are considered as primary outcomes and intubation, improving in subjective dyspnea, Pulse oximetry and respiratory rate, are considered as secondary outcome. The patients are compared in regard to these outcomes to see if adding nebulized aminophyline to the standard treatment would be able to improve the each of these outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082329494N1
Registration date:2017-03-01, 1395/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Bahare Mirzajani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 509 0914
Email address
mirzajanib931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of adding inhaled Aminophylline to the standard treatment of asthma in adults with acute severe asthma attack
Public title
Effects of inhaled Aminophylline for treatment of asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient older than 18 years old presented by severe asthma attack to
Exclusion criteria: not consent for participating in the study, uncooperative in physical exam, nebolizer, aminophylline contra-indications, pregnancy, present or history of tachdy-disrythmy , drug history of theophylline use.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Mashhad University of Medical Sciences
Street address
Ghorieshi Bulding. Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
IR.MUMS.sm.REC.1395.290
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J46
ICD-10 code description
Status asthmaticus
Primary outcomes
1
Description
Admit
Timepoint
6 hours later
Method of measurement
Admit- Non Admit
2
Description
PEFR
Timepoint
Before Treatment- one hour later treatment
Method of measurement
Utilizing PEFR
Secondary outcomes
1
Description
improving in subjective dyspnea
Timepoint
Before treatment- One hour later treatment
Method of measurement
NUMERIC RATING 10 Criteria
2
Description
Respiratory rate
Timepoint
Before and one hour later treatment
Method of measurement
Counting
3
Description
Pulse Oximetry
Timepoint
Before and one hour later treatment
Method of measurement
Utilizing Pulse Oximetry
Intervention groups
1
Description
Administration aminophylline through nebulizer in Intervention Group
Category
Treatment - Drugs
2
Description
administration distill water through nebulizer in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
emamrezahosoital
Full name of responsible person
bahareh mirzajani bajestani
Street address
emergency departement edalatian
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
mashhad University of Medical Sciences
Full name of responsible person
Dr. tafaghodi
Street address
mashahd research dpt, Ghorieshi Bulding, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Bahare Mirzajani Bajestani
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Emam Reza Hospital- Emergency department Edalatian
City
Mashhad
Postal code
Phone
+98 518525312
Fax
Email
mirzajanib931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Pishbin
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Emam Reza hospital- Emergency department Edalatian
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
pishbine@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bahare Mirzajani Bajestani
Position
resident of Emergency Medicine
Other areas of specialty/work
Street address
No.13, No.15 Sharif Avenue, No.59 Vakil Abad BLV
City
Mashhad
Postal code
Phone
00
Fax
Email
Mirzajanib931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)