Purpose: Decrease of respiratory tract inflammation in CF
prospective accidental study with 20 patients. Inclusion criteria: Confirmed CF with respiratory; gastrointestinal or urogenital symptom with positive test for CF in two times; (CL>60) male and female more than 8 years with potency of doing spirometry; stable vital sign without upper or lower respiratory tract infection; FEV1>50%.
Exclusion criteria: history of sensitivity to sildenafil or daily usage of systemic corticostroid or ibuprofen; LFT>3*normal; biliary cirhosis; portal hypertention; heart diseases such as aortic stenosis, arrhythmia, coronary artery disaeaes; neurological or hematologic or renal disaeas; takingof alfa blocker or nitrate or calcium blocker or CYP3A4 inhibitor such as ketoconazole or erythromycin; history of migraine; druge sensitivity or side effect or no patient inclination to continuation. First the patients do spirometry and FEV1/FVC, FEV1, FEF25-75 are measured then do exercise test for 6 minutes and then use sildenafil. At first 1mg/kg/day in 3 times for one week and then 1mg/kg/dose in 3 times for 3 months, then repeat the same tests. The results will be studied in SPSS18.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040920175N1
Registration date:2016-06-14, 1395/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-14, 1395/03/25
Registrant information
Name
Mohsen Reisi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 3678
Email address
mohsenreisi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Esfahan University of Medical Sciences
Expected recruitment start date
2016-02-21, 1394/12/02
Expected recruitment end date
2016-05-29, 1395/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the sildenafil efficacy in exercise test and spirometric value in CF
Public title
The effect of sildenafil in cystic fibrosis disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Confirmed CF with respiratory; gastrointestinal or urogenital symptom with positive test for CF in two times; (CL>60) male and female more than 8 years with potency of doing spirometry; stable vital sign without upper or lower respiratory tract infection; FEV1>50%.
Exclusion criteria: History of sensitivity to sildenafil or daily usage of systemic corticostroid or ibuprofen; LFT>3*normal; biliary cirhosis; portal hypertention; heart diseases such as aortic stenosis, arrhythmia, coronary artery disaeaes; neurological or hematologic or renal disaeas; takingof alfa blocker or nitrate or calcium blocker or CYP3A4 inhibitor such as ketoconazole or erythromycin; history of migraine; druge sensitivity or side effect or no patient inclination to continuation.
Age
From 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Esfahan University of Medical Sciences
Street address
Hezar-Jerib Street, Darvazeh-Shiraz
City
Esfahan
Postal code
Approval date
2015-02-18, 1393/11/29
Ethics committee reference number
3946
Health conditions studied
1
Description of health condition studied
Cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Mucoviscidosis
Primary outcomes
1
Description
FEV1/FVC
Timepoint
Before the study and 3months after the start
Method of measurement
Spirometry
2
Description
FEV1
Timepoint
Befor the study and 3 months after the stsrt
Method of measurement
Spirometry
3
Description
FEF25-75
Timepoint
Before the study and 3months after the start
Method of measurement
Spirometry
4
Description
Walking tolerance
Timepoint
Before the study and 3montha after the start
Method of measurement
Minute, ET test
Secondary outcomes
1
Description
Drug sensitivity
Timepoint
Weekly
Method of measurement
History
Intervention groups
1
Description
Tablet sildenafil; first: 1mg/kg/day in 3 times for 1 week and then 1mg/kg/dose 3 times in day for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Medical Center, Imam Hosein hospital
Full name of responsible person
Dr. Zahra Aghaei
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Pahlevannejad
Street address
Esfahan University of Medical Sciences
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?