Protocol summary

Study aim
This study is aimed to evaluate the effect of glucagon on the treatment of severe asthma attack.
Design
20 patients, 18 to 55 years, presenting to ED with asthma attack will be evaluated by physician. Their clinical status, vital sign, blood glucose, PEFR and FEV1 will be recorded. Patients who meet the inclusion criteria will be enrolled the study. All patients will receive the standard treatment of severe asthma attack (5 mg nebulized albuterol every 20 minutes for 3 doses, 0.5 mg ipratropium every 20 minutes for 3 doses, 50 mg oral prednisolone). Patients will be randomly assigned to either intravenous glucagon or a placebo medication (according to random number table).
Settings and conduct
All patients presenting to ED with asthma attack, considering the inclusion and exclusion criteria and in case of severe attack, in addition to the standard treatment , will randomly receive either 1 mg intravenous glucagon or its equivalent of normal saline. physicians evaluating cases, nurses injecting medication and patients do not know if patients are recieving glucagon or placebo; the medication is prepared by the fourth person. Spirometry will be repeated at 10, 15, 30, 45 and 60 minutes after injection. Blood glucose will be measured again at 20 minutes after intervention. All subjects will be reevaluated clinically after one hour. Ultimately all data gathered will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: severe asthma attack, age between 18 and 55 Exclusion criteria: History of diabetes mellitus, smoking, ischemic heart disease, emphysema or chronic bronchitis, insulinoma, pheochromocytoma, current oral or injectable corticosteroids, pregnancy, lactation, need for intubation.
Intervention groups
All patients with severe asthma attack will receive the standard treatment (5 mg nebulized albuterol every 20 minutes for 3 doses, 0.5 mg ipratropium every 20 minutes for 3 doses, 50 mg oral prednisolone). In addition to the standard treatment, patients will randomly receive either 1 mg intravenous glucagon or its equivalent of normal saline.
Main outcome variables
PEFR; FEV1

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131118015446N13
Registration date: 2018-02-17, 1396/11/28
Registration timing: registered_while_recruiting

Last update: 2018-02-17, 1396/11/28
Update count: 0
Registration date
2018-02-17, 1396/11/28
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 Science
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of Clinical And Peak Flow Metric Effect Of Intravenous Glucagon On Treatment Of Acute Severe Asthma Attack
Public title
Effect Of Glucagon on Treatment Of Acute Severe Asthma Attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Severe asthma attack Age between 18 and 55
Exclusion criteria:
History of diabetes mellitus Smoking Ischemic heart disease Emphysema or chronic bronchitis Insulinoma pheochromocytoma Current oral or injectable corticosteroids, pregnancy Pregnancy Lactation Need for intubation
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients know they are participating in a study that is aimed to evaluate the effect of glucagon on the treatment of severe asthma attack but they are not informed that they receive placebo or glucagon The physician who evaluates the clinical status of patients and the nurse who injects the drug are not aware of the medication that patients receive.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Science
Street address
Ahvaz Jundishapur University Of Medical Science, Golestan Highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-09-26, 1396/07/04
Ethics committee reference number
IR.AJUMS.REC.1396.474

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Peak Expiratory Flow Rate (PEFR)
Timepoint
At 0, 10, 15, 30, 45 ,60 minutes after intervention
Method of measurement
Litre/minute, by spirometry

2

Description
FEV1
Timepoint
At 0, 10, 15, 30, 45 ,60 minutes after intervention
Method of measurement
Litre, by spirometry

Secondary outcomes

1

Description
Respiratory rate
Timepoint
At 0 and 60 minutes after intervention
Method of measurement
Counting of respiration in one minute

2

Description
Pulse rate
Timepoint
At 0 and 60 minutes after intervention
Method of measurement
Counting of pulse in one minute

3

Description
Blood pressure
Timepoint
At 0 and 60 minutes after intervention
Method of measurement
mmHg, by sphygmomanometer

4

Description
Blood glucose
Timepoint
At 0 and 20 minutes after intervention
Method of measurement
mg/dL, by glucometer

5

Description
blood oxygen saturation levels (SpO2)
Timepoint
At 0 and 60 minutes after intervention
Method of measurement
Percentage, by pulse oximeter

Intervention groups

1

Description
Intravenous injection of 1 mg of glucagon over 1minute for case group
Category
Treatment - Drugs

2

Description
Intravenous injection of 1 mL normal saline for control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Dr Hassan Motamed
Street address
Golestan Hospital, Farvardin Street, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3374 3099
Email
golestanhospital@ajums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Hassan Motamed
Street address
Imam Khomeini Hospital, Azadegan Avenue, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3221 6504
Email
himam@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University Of Medical Science
Full name of responsible person
Dr Hassan Motamed
Street address
Department of emergency medicine, Golestan Hospital, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3099
Email
golestanhospital@ajums.ac.ir
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 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
Ahvaz Jundishapur University Of Medical Science
Full name of responsible person
Dr Hassan Motamed
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of emergency medicine, Golestan Hospital, Farvardin Street, Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3099
Fax
Email
motamed-h@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Science
Full name of responsible person
Dr Hassan Motamed
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of emergency medicine, Golestan Hospital, Farvardin Street, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3099
Fax
Email
motamed-h@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Science
Full name of responsible person
Dr Hassan Motamed
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of emergency medicine, Golestan Hospital, Farvardin Street, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3099
Fax
Email
motamed-h@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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