Evaluation of the efficacy of nebulized soluble mannitol and comparison with nebulized 5% hypertonic saline on pulmonary function of children with cystic fibrosis
Design
Two arm parallel group clinical trial with 30 patients
Settings and conduct
Study was performed on 30 children with cystic fibrosis older than 5 years of age who were referred to CF clinic in Mofid Children’s Hospital, Tehran, Iran. Patients were divided into two groups including soluble mannitol and 5% hypertonic saline group. Group 1 received nebulized soluble mannitol at 4 cc twice daily and group 2 received nebulized 5% hypertonic saline at 5 cc four times a day. In both groups treatment was performed for two weeks. A baseline and an after two weeks of treatment spirometry was done.
Participants/Inclusion and exclusion criteria
Children with cystic fibrosis older than 5 years who can perform spirometry; Patients less than 5 years.
Intervention groups
Group 1: Receiving nebulized soluble mannitol at 4 cc twice a day. Group 2: Receiving nebulized 5% hypertonic saline at 5 cc four times a day.
Main outcome variables
Pulmonary function based on spirometry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180307038994N1
Registration date:2018-04-15, 1397/01/26
Registration timing:retrospective
Last update:2018-04-15, 1397/01/26
Update count:0
Registration date
2018-04-15, 1397/01/26
Registrant information
Name
Masoud Kiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 0755
Email address
m.kiani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
2016-01-21, 1394/11/01
Actual recruitment end date
2016-06-20, 1395/03/31
Trial completion date
empty
Scientific title
Comparison of the nebulized Mannitol with nebulized Hypertonic saline on pulmonary function in patients with cystic fibrosis
Public title
Effect of Mucolytic in treatment of cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cystic fibrosis older than 5 years
Ability to perform spirometery
Exclusion criteria:
Age less than 5 years
Age
From 5 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
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 of Shahid Beheshti University of Medical Sciences
Street address
Arabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
IR.SBMU.SM.REC.1394.62
Health conditions studied
1
Description of health condition studied
Cystic fibrosis
ICD-10 code
E84.0
ICD-10 code description
Cystic fibrosis with pulmonary manifestations
Primary outcomes
1
Description
Pulmonary function based on spirometry
Timepoint
Spirometry at the beginning of study and at the end of study after two weeks of treatment
Method of measurement
Spirometry device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Receives soluble mannitol at a concentration of 150 milligram per milliliter at 4 cc twice a day via nebulizer device.
Category
Treatment - Drugs
2
Description
Intervention group 2: Receives hypertonic saline 5% at 5 cc four times a day via nebulizer device.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children’s hospital
Full name of responsible person
Masoud Kiani
Street address
Shariati St
City
Tehran
Province
Tehran
Postal code
15514- 15468
Phone
+98 21 2222 7029
Email
info-mch@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud Kiani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkola Children’s hospital, Amirkola, Babol
City
Babol
Province
Mazandaran
Postal code
7411514731
Phone
+98 11 3234 0755
Email
m.kiani@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud Kiani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkola Children’s hospital, Amirkola, Babol
City
Babol
Province
Mazandaran
Postal code
7411514731
Phone
+98 11 3234 0755
Email
m.kiani@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud Kiani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkola Children’s hospital, Amirkola. Babol
City
Babol
Province
Mazandaran
Postal code
7411514731
Phone
+98 11 3234 0755
Email
m.kiani@mubabol.ac.ir
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
Not applicable
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