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Evaluation of the effectiveness of 7% plus hypertonic saline in comparison with 7% hypertonic saline in reducing the growth of Pseudomonas aeruginosa in lung of the patient with cystic fibrosis disease.

Protocol summary

Study aim
To determine the effectiveness of inhalation of hypertonic salin7% plus in comparison with inhalation of hypertonic salin7% in reducing the growth of P. aeroginosa, in the lungs of patients with cystic fibrosis.
Design
parallel group non-randomised Clinical trial with control .
Settings and conduct
Patients are nonrandomized divided into two groups, the intervention group, hypertonic saline 7% plus inhalation, and the control group, hypertonic saline 7% inhalation, which is used with a jet nebulizer at intervals of every 12 at home for two months. The study is measured before and after drug administration and is then compared between the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients have cystic fibrosis,patients have the ability to excrete sputum,The disease is in a stable condition (not in exacerbation), (FEV1) is above 50%.have pseudomonas in sputum culture. Exclusion criteria: Hyper reactive airway disease, Oxygen saturation less than 94% in room air or with supplemental oxygen, Change in cystic fibrosis drugs during the previous 4 weeks, Untreated reflux.
Intervention groups
The intervention group is treated with hypertonic saline 7% plus inhalation and the control group is treated with hypertonic saline 7% inhaled.hypertonic salin plus contains bicarbonate for diluting of sputum and inhibit P.Aeroginosa growth in sputum.The nebulizer is used twice a day, for 2 months. This drug is Iranian and made by Samen Pharmaceutical Group.
Main outcome variables
Weigt,Colony count of p.aeroginosa in sputum culture, Quality of life ,FEV1,FVC,LCI

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201017049055N1
Registration date: 2021-04-23, 1400/02/03
Registration timing: registered_while_recruiting

Last update: 2021-04-23, 1400/02/03
Update count: 0
Registration date
2021-04-23, 1400/02/03
Registrant information
Name
Fateme Tarighat monfared
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2227 6175
Email address
fateme.tarighat@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of 7% plus hypertonic saline in comparison with 7% hypertonic saline in reducing the growth of Pseudomonas aeruginosa in lung of the patient with cystic fibrosis disease.
Public title
Effect of hypertonic salin7% plus in treatment of Pseudomonas aeruginosa in the lung of the patient with cystic fibrosis disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
positive sputum culture with Pseudomonas aeruginosa The patient has the ability to excrete sputum The disease is in a stable condition (not in exacerbation) Forced expiratory volume(FEV1) is above 50%. have cystic fibrosis disease.
Exclusion criteria:
have hyper reactive airway disease. O2 saturation below 94%, in air room or when treated with oxygen. changes in cystic fibrosis drug over the past 4 weeks. have untreated reflux disease.
Age
From 6 years old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
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 in Research of Pediatric Medical Center-Tehran University of Medical Sciences.
Street address
No. 62, Pediatric Medical Center, Next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., End of Keshavarz Blvd., Tehran.
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2020-10-08, 1399/07/17
Ethics committee reference number
IR.TUMS.CHMC.REC.1399.133

Health conditions studied

1

Description of health condition studied
cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis

Primary outcomes

1

Description
Nomber of colony count of pseudomonas aeroginosa.
Timepoint
It is measured before prescribing the drug and then 2 months after prescribing the drug.
Method of measurement
Counting colonies after sputum culture.

2

Description
Weight
Timepoint
It is measured before prescribing the drug and then 2 months after prescribing the drug.
Method of measurement
scale

3

Description
Forced expiratory volum in first second (FEV1)
Timepoint
It is measured before prescribing the drug and then 2 months after prescribing the drug.
Method of measurement
Spirometry

4

Description
LCI (Lung clearance index)
Timepoint
It is measured before prescribing the drug and then 2 months after prescribing the drug.
Method of measurement
Polmonary function test(LCI)

5

Description
Quality of life
Timepoint
It is measured before prescribing the drug and then 2 months after prescribing the drug.
Method of measurement
CFQ-R Questionnaire

6

Description
Forced vital capacity(FVC)
Timepoint
It is measured before prescribing the drug and then 2 months after prescribing the drug.
Method of measurement
Spirometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the usage of hypertonic saline 7% plus inhalation by a nebulizer ,twice a day for 2 months.drug Produced by Samen Pharmaceutical Company of Mashhad.
Category
Treatment - Drugs

2

Description
control group: the usage of hypertonic saline 7% inhalation by a nebulizer ,twice a day for 2 months.drug Produced by Samen Pharmaceutical Company of Mashhad.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's medical center
Full name of responsible person
Fateme Tarighat Monfared
Street address
No. 62, Next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., at the end of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
fateme.tarighat@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad ali Sahraeian.
Street address
Central Campus of the University of Tehran, Vice Chancellor for Research, 16 Azar St., Enghelab St., Enghelab Square, Tehran
City
tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6649 8813
Email
resaerch@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fateme Tarighat monfared
Position
Polmonary subspecialties assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.50 (unit 2), Mahshid Alley ., End of north motahary., Sabr alley., Zafar Ave., Dr Shariaty Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1913883113
Phone
+98 21 2227 6175
Fax
Email
fateme.tarighat@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Tarighat monfared
Position
Polmonary subspecialties assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.50 (unit 2), Mahshid Alley ., End of north motahary., Sabr alley., Zafar Ave., Dr Shariaty Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1913883113
Phone
+98 21 2227 6175
Fax
Email
fateme.tarighat@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Tarighat monfared
Position
Polmonary subspecialties assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No.50 (unit 2), Mahshid Alley ., End of north motahary., Sabr alley., Zafar Ave., Dr Shariaty Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1913883113
Phone
+98 21 2227 6175
Fax
Email
fateme.tarighat@gmail.com

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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