The aim of this study is evaluation of the effect of Pirfenidone in clinical outcome of Idiopathic Pulmonary Fibrosis (IPF) progression
This is a single center, double-blind randomized phase 2-3 clinical trial
The main inclusion criterion of this study is confirmed IPF by biopsy and The main exclusion criteria are the history of connective tissue disease and deny to participate in this study.
We will enroll 40 patients with IPf. Participants will randomly be assigned into intervention and control groups and will receive Pirfenidone (1200 mg daily) and placebo respectively for 3 and 6 months. As the primary outcome of our study, the DLCO and pulmonary function test will be measured before and after the intervention. We will compare the results between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031333044N1
Registration date:2017-07-13, 1396/04/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-13, 1396/04/22
Registrant information
Name
Aliasghar Karimi
Name of organization / entity
Fasa University of medical Sceinsces
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 0994
Email address
dr_aliasgharkarimi@gmj.ir
Recruitment status
Recruitment complete
Funding source
Respiratory Diseases Institute, Masih Daneshvar Hospital, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Pirfenidone versus placebo in Idiopathic Pulmonary Fibrosis progression: a randomize clinical trial
Public title
Efficacy of Pirfenidone versus placebo in Idiopathic Pulmonary Fibrosis progression:a randomize clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Confirmed Idiopathic Pulmonary Fibrosis with lung biopsy
2-UIP view in lung HRCT with unknown cause base of ATS-ERS criteria
3-Agreement to participate in this study
Exclusion criteria:
1-Suffering from connective tissue disease
2-occupational exposure to substances that cause lung fibrosis
3-close contact with animals
4-Deny to participate in this study
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Participants will randomly be assigned into intervention and control groups by table of random numbers .
To reduce the bias, This is a double-blind randomized clinical trial so that patients and investigators not aware about their group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Before the intervention, three months after the intervention and six months after intervention
Method of measurement
Body box
Secondary outcomes
1
Description
Functional Lung Capacity
Timepoint
Before the intervention, three months after the intervention and six months after intervention
Method of measurement
Body box
2
Description
SPO2
Timepoint
Before the intervention, three months after the intervention and six months after intervention
Method of measurement
Body box
3
Description
DLCO
Timepoint
Before the intervention, three months after the intervention and six months after intervention
Method of measurement
Body box
Intervention groups
1
Description
Intervention group No.1:
pirfenidone (PIRFENEX 200 mg manufactured by Cipla Ltd) will be added to their previous medication.
The final dosage of pirfenidone is 1200 mg daily. At first, the drug will start at three times a day (600 mg) and will gradually be given at a dose of 400 mg 3 times a day (1200 mg) over a period of 2 weeks. All patients will be received anti-acid secretion, such as proton pumps inhibitors, Also they should use a sunscreen with spf> = 50.
Category
Treatment - Drugs
2
Description
Intervention group No.2:
Placebo will be added to previous medication of these patients
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Yusef Gholampour
Street address
Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Behesti University of Medical Sciences