Compare of Forced Expiratory Volume in 1 second (FEV1) and FEV1/Forced Vital Capacity(FVC) after use fluticasone/salmeterol in the form of Metered-dose Injaler (MDI) and Dry Powder Inhaler( DPI) for the treatment of children's asthma.
Comparison of Forced Expiratory Volume in 1 second (FEV1),/Forced Vital Capacity (FVC) , FEV1/FVC , Forced Expiratory Flow (FEF) in two groups treated with combination fluticasone/salmeterol in the form of Metered Dose Inhaler (MDI) with form of Dry Powder Inhaler ( DPI) in asthma in children.
Design
86 children over six years old with moderate asthma who required combined ICS/LABA treatment. These children were referred to the Masih Daneshvari Hospital clinic and were randomly divided into two equal groups. One group received treatment via MDI, while the other group used DPI inhalation.
Settings and conduct
The firs in Masih daneshvari hospital, spirometry was performed for all participants. After one month of treatment, a follow-up spirometry was conducted. The treatment groups were then switched: those initially using MDI were switched to DPI, and vice versa. Spirometry was repeated one month after the switch, and the results were analyzed and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria
- Children over 6 years old with moderate asthma need combined treatment with ICS/LABA.
-stable condition
-parent consent
Exclusion criteria
- Patients with emergency conditions such as asthma exacerbation
Intervention groups
The group using fluticasone/salmeterol combination in MDI form.
The group using fluticasone/salmeterol combination in DPI form.
Main outcome variables
Lung Volumes
Symptoms
Drug Side Effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220812055665N2
Registration date:2025-10-07, 1404/07/15
Registration timing:retrospective
Last update:2025-10-07, 1404/07/15
Update count:0
Registration date
2025-10-07, 1404/07/15
Registrant information
Name
Zohre Akbari jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3623 9056
Email address
zohreakbari2351@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
2023-04-21, 1402/02/01
Actual recruitment end date
2024-03-20, 1403/01/01
Trial completion date
2024-04-20, 1403/02/01
Scientific title
Compare of Forced Expiratory Volume in 1 second (FEV1) and FEV1/Forced Vital Capacity(FVC) after use fluticasone/salmeterol in the form of Metered-dose Injaler (MDI) and Dry Powder Inhaler( DPI) for the treatment of children's asthma.
Public title
Compare of FEV1 and FEV1/FVC after use fluticasone/salmeterol in the form of MDI and DPI for the treatment of children's asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children over 6 years with moderate asthma requiring therapy with ICS/LABA
stable condition
Parental consent
Exclusion criteria:
Unstable condition
Age
From 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Actual sample size reached:
86
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Medical University of Shahid Beheshti
Street address
No 15, Salmasi, South Mofatteh ,Haft Tir Square
City
Tehran
Province
Tehran
Postal code
1573633916
Approval date
2023-05-22, 1402/03/01
Ethics committee reference number
IR.SBMU.MSP.REC.1402.232
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J45.9
ICD-10 code description
Other and unspecified asthma
Primary outcomes
1
Description
Forced Expiratory Volume in 1 second (FEV1)
Timepoint
beginning of the study , One month after starting teatment , One month after starting treatment
Method of measurement
Spirometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the combination of fluticasone/salmeterol inhaler in the form of MDI is used every 12 hours at the dose required by the patient for one month, in the second month, the combination of fluticasone/salmeterol inhaler in the form of DPI is prescribed to the patient every 12 hours. The dose used varies based on each patient. On average, a dose of 25/125 is used.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, the combination of fluticasone/salmeterol inhaler in the form of DPI is used every 12 hours at the dose required by the patient for one month, in the second month, the combination of fluticasone/salmeterol inhaler in the form of MDI is prescribed to the patient every 12 hours. The dose used varies based on each patient.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Zohre Akbari Jokar
Street address
darabad
City
tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2712 3000
Email
Zohreakbari2351@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
zohre akbari jokar
Street address
velenjak
City
tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2243 9770
Email
zohreakbari2351@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohre Akbari Jokar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No.15, Salmasi , South Mofateh , 7th Tir Square, Tehran
City
Tehran
Province
Tehran
Postal code
11111111111
Phone
+98 21 2243 9770
Email
zohreakbari2351@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohre Akbari Jokar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No15, Salmasi,South Moffateh , Hafte Tir Square
City
Tehran
Province
Tehran
Postal code
11111111111
Phone
+98 21 2243 9770
Email
zohreakbari2351@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohre Akbari Jokar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 15, Salmasi, South Mofatteh , Hafte Tir Square
City
Tehran
Province
Tehran
Postal code
11111111111
Phone
+98 21 2243 9770
Email
zohreakbari2351@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
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