The effect of montelukast on the serum levels of inflammatory factors in patients with chronic obstructive pulmonary disease (COPD) in intervention and control groups
The aim of this study was to assess the effect of montelukast on the serum level of inflammatory factors in patients with chronic obstructive pulmonary disease.
Design
Clinical trial with a control group with parallel groups, not blinded and not randomized.
Settings and conduct
Patients will be examined from May 2018 to September 2018 at Shahid Rahimi Hospital in Khorramabad. Patients are randomly divided into two groups. The first group will receive Monte-Lucas and the second group will receive the placebo for 2 months. Blood samples are taken from patients and inflammatory factors such as TNF, CRP, and IL-18 are measured. During the study, doctors and all patients are blind.
Participants/Inclusion and exclusion criteria
Patients with chronic obstructive pulmonary disease, aged 40-70 years, and in stage II-III-IV disease, with stable conditions in the last trimester were considered as the study group, and patients with a history of hospitalization, long-term corticosteroid consumption, another inflammatory diseases, cardiovascular disease, rheumatoid arthritis, lung and liver disease were not studied.
Intervention groups
In one cycle of treatment the patients receives 10 mg of montelukast once a day for two months. In addition in control group will use similar placebo.
Main outcome variables
serum levels of common inflammatory factors such as TNF-α, CRP and IL-18 in COPD patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190423043361N1
Registration date:2019-08-26, 1398/06/04
Registration timing:retrospective
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Nazanin Kordalivand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3330 5324
Email address
nazanin.kordalivand97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of montelukast on the serum levels of inflammatory factors in patients with chronic obstructive pulmonary disease (COPD) in intervention and control groups
Public title
Montelukast effect in patients with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
COPD patients
aged 40 to 70 years
Patients with stable conditions in the last trimester
Patients who are at stages II-III-IV of the disease
Exclusion criteria:
History of hospitalization
History of long-term Corticosteroid use
Other inflammatory diseases such as cardiovascular, rheumatic, pulmonary, and liver disease
Age
From 40 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 lorestan University of Medical Sciences
Street address
Shahid Anooshirvan Rezaie Square, University of Medical Sciences, Moallem street, Khorramabad, Lorestan
City
khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
IR.LUMS.REC.1396.321
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
TNF-α level
Timepoint
60 days
Method of measurement
ELISA Diagnostic Kits
2
Description
level of IL-18
Timepoint
60 days
Method of measurement
ELISA Diagnostic Kits
3
Description
levels of CRP
Timepoint
60 days
Method of measurement
semiquantitative C-reactive protein latex agglutination kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In one cycle of treatment the patients receives 10 mg of montelukast, Poursina factory production, once a day for two months.
Category
Treatment - Drugs
2
Description
Control group: The same placebo, Poursina factory production, take one times per day, for 2 month