Study the Effectiveness of Outpatient treatment in Cystic Fibrosis Patients in Exacerbation Phase
Design
Clinical trial without control group
Settings and conduct
This study was conducted at Children Medical Centre (CMC) located in Tehran, Iran.
All the eligible patients initially referred to the CMC pulmonary tests center to determining the lung volumes and capacities.
After that, the patients were treated, according to accepted therapeutic protocol of CF center of CMC, out patiently for 2 to 4 weeks based on the severity of signs and symptoms.
After complement of treatment course, the patients underwent all the previous tests again and data before and after treatment, compared.
Participants/Inclusion and exclusion criteria
Documented diagnosed CF patients older than 6 years who are in exacerbation phase and are also able to perform pulmonary tests physically and mentally
Intervention groups
Outpatient treatment with antibiotics and supportive cares
Main outcome variables
Decrease in airway resistance and lung residual volume and increase in FRV1 and total lung capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191112045413N2
Registration date:2020-02-14, 1398/11/25
Registration timing:retrospective
Last update:2020-02-14, 1398/11/25
Update count:0
Registration date
2020-02-14, 1398/11/25
Registrant information
Name
Mehrnaz Olfat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7703 7596
Email address
olfat.mehrnaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2018-04-21, 1397/02/01
Trial completion date
2018-04-21, 1397/02/01
Scientific title
Study the Effectiveness of Outpatient treatment in Cystic Fibrosis Patients in Exacerbation Phase
Public title
Study the effectiveness of outpateint treatment of cystic fibrosis exacerbation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Documented diagnosis of CF
Exacerbation phase
Older than 6 years
Exclusion criteria:
Patients unable to perform pulmonary tests because of physical or mental limitations
Age
From 6 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
29
Actual sample size reached:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
District 6, Keshavarz Boulevard and Ghods St. crossing. Main Office of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-01-24, 1396/11/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.4323
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
Percent of patients with increased FEV1 values
Timepoint
Before initiation of outpatient treatment and after completion of treatment
Method of measurement
Spirometry machine
2
Description
Percent of patients with decreased residual volumes of lungs
Timepoint
Before initiation of outpatient treatment and after completion of treatment
Method of measurement
body box (plethysmograph) machines
3
Description
Percent of patients with increased total lung capacities of lungs
Timepoint
Before initiation of outpatient treatment and after completion of treatment
Method of measurement
body box (plethysmograph) machines
4
Description
Percent of patients with decreased airway resistance
Timepoint
Before initiation of outpatient treatment and after completion of treatment
Method of measurement
Impulse oscillometry machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Airway clearance therapy by nebulized Hypertonic saline (3, 5 or 7%) and nebulized Ventolin, chest physiotherapy (at least 4 times a day). Oral antibiotic therapy based on sputum and pharyngeal culture, out patiently for 2-4 weeks.Treatment of dehydration and electrolyte corrections by taking oral liquids at home.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center Hospital
Full name of responsible person
Alireza Daneshi Bakhtiar
Street address
No. 62, Mohammad Gharib Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2727
Email
cmcpr@tums.ac.ir
Web page address
http://chmc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
District 6, Keshavarz Boulevard and Ghods St. crossing. Main Office of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8670 5503
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?