- Determining the effectiveness of inhaler furosemide in patients with acute asthma attack in terms of FEV1 compared to the control group
- Determining the effectiveness of inhaler furosemide in patients with acute asthma attack in terms of PEFR compared to the control group
- Determining the effectiveness of inhaler furosemide in patients with acute asthma attack in terms of clinical criteria of asthma (CAS) in comparison with the control group
- Determine the effectiveness of inhaler furosemide in patients with acute asthma attack in terms of patient residence in emergency department in comparison with the control group
Design
This study was performed as a clinical trial of one-blind phase 3. 90 patients with acute asthma attack were Non randomly divided into two groups of 45 (parallel) intervention and control.
Settings and conduct
This study was conducted at the Shahid Rajai hospital in Karaj. Patients were not aware of the type of treatment. Each patient was assigned a blind direction code.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Asthma diagnosis
The incidence of mild to moderate asthma attack (the clinical criterion of asthma 1 to 6)
Ability to perform respiratory tests
Exclusion criteria:
Start over 10 hours of symptoms
History of smoking over 10 pack-year
Simultaneous acute illness
Pregnancy
Beta 2 agonist consumption in 6 hours before referral
Pneumonia
Intervention groups
In the intervention group, patients, in addition to oxygen, received salbutamol with a dose of 5 mg and Frosemide with a dose of 40 mg with nebuliser Mask.
In the control group, oxygen and salbutamol with a dose of 5 mg prescribed for patients with nebuliser Mask..
Patients in both groups received 300 mg of Hydrocortisone intravenously.
Main outcome variables
FEV1
PEFR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180522039784N2
Registration date:2021-11-25, 1400/09/04
Registration timing:prospective
Last update:2021-11-25, 1400/09/04
Update count:0
Registration date
2021-11-25, 1400/09/04
Registrant information
Name
Pouria Chaghamirzayi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3450 2485
Email address
pouriachaghamirzayi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of inhaled furosemide in patients with acute asthma attack
Public title
Evaluation of the effectiveness of inhaled furosemide in patients with acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Asthma diagnosis
The incidence of mild to moderate asthma attack (the clinical criterion of asthma 1 to 6)
Ability to perform respiratory tests
Exclusion criteria:
Start over 10 hours of symptoms
History of smoking over 10 pack-year
Simultaneous acute illness
Pregnancy
Beta 2 agonist consumption in 6 hours before referral
Pneumonia
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
At the beginning of the study, a code will be defined for each patient that the patient will not be aware of the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Intervention group: In the intervention group, patients, in addition to oxygen, received salbutamol with a dose of 5 mg and Frosemide with a dose of 40 mg with nebuliser Mask.Patients in both groups received 300 mg of Hydrocortisone intravenously.
Category
Treatment - Drugs
2
Description
Control group: In the control group, oxygen and salbutamol with a dose of 5 mg prescribed for patients with nebuliser Mask.Patients in both groups received 300 mg of Hydrocortisone intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Dariush Shiri
Street address
Shahid Rajaee Hospital - Ghalam Street - Hesarak
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3455 2001
Email
Rajaei@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr Reza Bayrami
Street address
Nabovvat Blvd
City
Karaj
Province
Alborz
Postal code
1631735361
Phone
+98 26 3255 5000
Email
abzumc.ac.ir@gmial.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?