To evaluate the additive effects of losaretan in treatment of chronic obstructive lung disease. 45 patients, as treatment group, received losartan and 45 patients, as control group, received placebo for 4 months. Patients were evaluated based on spirometry and dyspnea severity index and hematocrit before and after treatment. Inclusion criteria: history of chronic obstructive lung disease base on spirometry data and clinical sign and symptoms referred by pulmonologist. Exclusion criteria: congestive heart failure; renal failure; myocardial infarction in 6monthes ego; consumption of angiotensine converting enzyme inhibitors and angitensine receptors blockers; dehydration; renal artery stenosis; hyperkalemia; uncontrolled hypertension; allergy to losaretan.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103166080N1
Registration date:2012-03-09, 1390/12/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-09, 1390/12/19
Registrant information
Name
Seied Hesamodin Tabaei
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1412 0489
Email address
dr.htaba@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of medical sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-01-20, 1390/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of additive therapy of losaretan in chronic obstructive pulmonary disease
Public title
Effects of additive therapy of losaretan in chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of chronic obstructive lung disease base on spirometry data and clinical sign and symptoms referred by pulmonologist. Exclusion criteria: congestive heart failure; myocardial infarction in 6 months ego; consumption of angiotensine converting enzyme inhibitors and angiotensine receptor blockers; dehydration; renal artery stenosis; hyperkalemia; uncontrolled hypertension; allergy to losaretan.
Age
From 35 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak university of medical sciences
Street address
Pardis educational site, Bassije square, Sardasht
City
Arak
Postal code
3848176941
Approval date
2011-02-24, 1389/12/05
Ethics committee reference number
89-101-4
Health conditions studied
1
Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
FVC-percent of forced vital capacity
Timepoint
4months
Method of measurement
By spirometer
2
Description
FEV1—Forced expiratory volume in one second percent of
Timepoint
4 month
Method of measurement
By spirometr
3
Description
Hematocrit
Timepoint
4 month
Method of measurement
Percent and by coulter sysmex
4
Description
Fev1/fvc
Timepoint
4 months
Method of measurement
By spirometer
5
Description
FEF25%-75%
Timepoint
4months
Method of measurement
By spirometer
6
Description
Severity of dyspnea
Timepoint
4 months
Method of measurement
Grade and by modified medical research council-MMRC Scale
Secondary outcomes
1
Description
Raising of creatinine
Timepoint
1 month
Method of measurement
laboratory
Intervention groups
1
Description
Treatment group: 12.5 milligram losaretan, twice daily for 1 months, and if it is tolerated and creatinine does not raise, it is continuing with 25 milligram for 3 months.
Category
Treatment - Drugs
2
Description
Control group: placebo, twice daily for 4 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Mehdi Bakhtiar
Street address
Amiralmomenin, Sardasht
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr Said Changizi Ashtiany
Street address
Department of education and Research, University of medical sciences, Pardis site, Bassije square
City
Arak
Grant name
پژوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of medical sciences
Full name of responsible person
Dr. Mehdi Bakhtiar
Position
Internal medicine specialist, pulmonologist
Other areas of specialty/work
Street address
Amiralmomenin hospital arak
City
Arak
Postal code
3848176941
Phone
+98 86 1417 3608
Fax
+98 86 1417 3630
Email
Mehdi-bakhtiar@yahoo.co.uk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of medical sciences
Full name of responsible person
Dr. Mehdi Bakhtiar
Position
Internal medicine specialist, pulmonologist
Other areas of specialty/work
Street address
Amiralmomenin hospital arak
City
Arak
Postal code
3848176941
Phone
+98 86 1417 3608
Fax
+98 86 1417 3630
Email
mehdi-bakhtiar@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of medical sciences
Full name of responsible person
Dr Seied Hesamodin Tabaei
Position
Internal medicine resident
Other areas of specialty/work
Street address
Amiralmomenin hospital arak
City
Arak
Postal code
3848176941
Phone
+98 86 1417 3608
Fax
+98 86 1417 3630
Email
Dr.htaba@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)