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Comparing the efficacy of nebulized Azithromycin with oral Azithromycin in pulmonary function parameters in CF patients

Protocol summary

Summary
This study conducted to investigate the efficacy of nebulized Azithromycin on pulmonary parameters and SA colonization in sputum and quality of life in CF patients. Recent study is prospective randomized clinical trial. Patients enrolled into the study were 8 to 18 years of age with a documented CF diagnosis (sweat tests more than 60 mEq/L at least two times), and had FEV1 _ 25% to _ 75% predicted at baseline, and chronic PA airway infection, not recent (day _28 to screening) administration of inhaled, IV, or oral antipseudomonal antibiotics, not administration of oral Azithromycin at least for two months, not administration of nebulized Amikacin at least for one months. Exclusion criteria included current oral corticosteroid, lung transplantation; recent changes in antimicrobial, bronchodilator, antiinflammatory, or corticosteroid medications, or physiotherapy technique/ schedule; smear-positive sputum for non- Mycobacterium tuberculosis. Sample size is 50. Patients randomly assigned to 28 days of treatment with 70 mg of nebulized AZT or oral AZT every other day (250 mg for weight less than 40 kg and 500 mg for weight more than 40 kg). every group also nebulized aerosolized hypertonic saline solution and salbutamol every day. At treatment end (day 28), spirometry will be performed and sputum will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016100930233N1
Registration date: 2016-10-30, 1395/08/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Andisheh Maneshi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 5250
Email address
a-maneshi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of nebulized Azithromycin with oral Azithromycin in pulmonary function parameters in CF patients
Public title
Effect of nebulized Azithromycin in cystic fibrosis disease
Purpose
Treatment
Inclusion/Exclusion criteria
Patients enrolled into the study were: 8 to18 years old with a documented CF diagnosis (sweat tests more than 60 mEq/L at least two times) and had moderate-to-severe lung disease (FEV1 _ 25% to _ 75% predicted) and PA airway infection (documented at screening or two times within previous year; including once within the previous 3 months) not recent (ie, day _28 to screening) administration of inhaled, IV, or oral antipseudomonal antibiotics, not administration of oral Azithromycin at least for two months ( 2 months wash out or has not administered yet or stop taking oral Azithromycin at least for 2 months ). Exclusion criteria: current oral corticosteroid, lung transplantation; recent changes in antimicrobial, bronchodilator, antiinflammatory, or corticosteroid medications, or physiotherapy technique/ schedule; smear-positive sputum for non- Mycobacterium tuberculosis.
Age
From 8 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-12-15, 1394/09/24
Ethics committee reference number
IR.TUMS.REC.1394.1403

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
pseudomonas aeruginosa colony count
Timepoint
screening, Baseline,+28 day Treatment
Method of measurement
sputum Test and culture

2

Description
FEV1
Timepoint
screening, Baseline,+28 day Treatment
Method of measurement
spirometry

3

Description
pseudomonas aeruginosa phenotype
Timepoint
Screeninig, Baseline,+28 day Treatment
Method of measurement
sputum Test and culture

4

Description
pseudomonas aeruginosa resistance pattern
Timepoint
Screeninig, Baseline,+28 day Treatment
Method of measurement
sputum Test and culture

Secondary outcomes

empty

Intervention groups

1

Description
In treatment group patients assigned to 28 days of treatment with 70 mg of nebulized AZT
Category
Treatment - Drugs

2

Description
In control group patients assigned to 28 days of treatment with oral AZT every other day (250 mg for weight less than 40 kg and 500 mg for weight more than 40 kg).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children Medical Center
Full name of responsible person
Street address
Children Medical Center, Dr. Gharib st.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Vice chancellor for research,Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran 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
Children Medical Center
Full name of responsible person
Dr. Andisheh Maneshi
Position
Clinical pharmacist resident
Other areas of specialty/work
Street address
Children Medical Center, Dr. Gharib st.
City
Tehran
Postal code
Phone
+98 21 8800 5250
Fax
Email
phamaneshi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Andisheh Maneshi
Position
Clinical pharmacist resident
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Faculty of pharmacy ,clinical pharmacist ward
City
Tehran
Postal code
Phone
+98 21 8800 5250
Fax
Email
phamaneshi@gmail.com; a-maneshi@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Andisheh Maneshi
Position
Clinical pharmacist resident
Other areas of specialty/work
Street address
Faculty of Pharmacy of Tehran University of Medical Sciences, 16 Azar Street, Enghelab Square, Tehran
City
Tehran
Postal code
1439765543
Phone
+98 21 8800 5250
Fax
+98 21 8800 5250
Email
phamaneshi@gmail.com; a-maneshi@razi.tums.ac.ir
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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