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The effect of Tacrolimus on improving clinical symptoms, FEV1 and PEFR in patients with acute asthma attack ; Randomized clinical trial

Protocol summary

Summary
The aim of this study is the evaluation of effects of Tacrolimus on improving clinical symptoms, FEV1 and PEFR in patients with acute asthma attack. This double blind randomized clinical trial will be carried out on 70 patients with severe asthma, who are referred to emergency department due to an asthma attack. The intervention group will be received 0.5 mg ipratropium nubulized (repeated up to 3 doses in every 20 minutes), 5 mg Albuterol inhalation and Prednisolon at the beginning (zero time point). Also, 2 mg nebulized Tacrolimus (2 mg Tacrolimus, diluted in 2 cc of normal saline). The control group will be received 0.5 mg nubulized ipratropium (repeated up to 3 doses in every 20 minutes), 5 mg Albuterol inhalation and Prednisolon at the beginning (zero time point), similar to experimental group, as well as taking 2 cc nubulized normal saline as placebo in the beginning. Pulmonary function (FEV1 and PEFR), hemodynamic variables (blood pressure, pulse and respiration rate, pressure of oxygen in arterial blood) will be compared at the time points of 0, 30, 60, 90 and 120 after the intervention for all the studied patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017063015446N11
Registration date: 2017-07-25, 1396/05/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-25, 1396/05/03
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, Ahvaz, Iran
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2018-08-01, 1397/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tacrolimus on improving clinical symptoms, FEV1 and PEFR in patients with acute asthma attack ; Randomized clinical trial
Public title
Tacrolimus in improving clinical symptoms patients with acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the age between 18 and 65 years; patients with shortness of breath; cases with a history of asthma that correlate with their clinical and paraclinical parameters Exclusion criteria: The patients with tacrolimus allergy; HCO-60 (polyoxyl 60 hydrogenated castor oil); Hyperpigmentation scars, diabetes mellitus; renal failure; heart failure; electrolyte disorders; uncontrolled blood pressure; neurologic disorders; lymphoma and other malignancies; pregnancy and breast feeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
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
Randomization was done by block randomization method

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blv
City
Ahvaz
Postal code
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.AJUMS.REC.1395.768

Health conditions studied

1

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

Primary outcomes

1

Description
PEFR
Timepoint
0,30,60,120 and 150 minutes after treatment
Method of measurement
spirometry

2

Description
FEV1
Timepoint
0,30,60,120 and 150 minutes after treatment
Method of measurement
spirometry

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive 0.5 mg ipratropium nubulized (repeated up to 3 doses in every 20 minutes) , 5 mg Albuterol inhalation and Prednisolon at the beginning (zero time point). Also, 2 mg nebulized Tacrolimus (2 mg Tacrolimus diluted in 2 cc of normal saline).
Category
Treatment - Drugs

2

Description
The control group will receive 0.5 mg nebulized ipratropium (repeated up to 3 doses in every 20 minutes) , 5 mg Albuterol inhalation and Prednisolon at the beginning (zero time point).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Hassan Motamed
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hasan Motamed
Street address
Farvardin Blv
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 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
Hasan Motamed
Position
M.D
Other areas of specialty/work
Street address
Farvardin Blv
City
Ahvaz
Postal code
Phone
+98 61 3374 3009
Fax
Email
mtdhsn@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hasan Motamed
Position
M.D
Other areas of specialty/work
Street address
Farvardin Blv
City
Ahvaz
Postal code
Phone
+98 61 3374 3009
Fax
Email
mtdhsn@gmail.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
Hasan Motamed
Position
M.D
Other areas of specialty/work
Street address
Farvardin Blv
City
Ahvaz
Postal code
Phone
+98 61 3374 3009
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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