Protocol summary

Study aim
Determining the effectiveness of azithromycin treatment protocol and standard treatment in comparison with standard treatment alone in patients with chronic obstructive pulmonary disease (COPD)
Design
A controlled, double-blind, placebo, randomized controlled clinical trial is performed on 100 patients. For randomization, the blocking method (quadruple blocks) will be used.
Settings and conduct
Two-blind study. Patients are first subjected to initial pulmonary examinations to determine the initial values of functional tests. Then, until random allocation, they are placed in the intervention and control groups, and spirometric indices and the rate of improvement and control of the disease are recorded using CAT and MMRC questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria Diagnosis of COPD by an internal medicine specialist, hospitalization based on the global pioneers of chronic obstructive pulmonary disease (GOLD), stable physical and mental condition of the patient, age 40-70 years, no other chronic diseases such as disease Of orthopedics and locomotion, multiple sclerosis and cancer. Exclusion criteria Lack of motivation for the patient to continue cooperation, immune system deficiency (recurrent respiratory infections and worsening of shortness of breath), pneumonia, embolism. Kidney failure, hearing loss Existence of concomitant asthma Complications of azithromycin Existence of atopy or allergic rhinitis Cancer Serious non-pulmonary disease Liver dysfunction, cholestatic jaundice, infiltration and cosolidation on chest x-ray Patients with acute exacerbation of COOD are also excluded from the study.
Intervention groups
Intervention group: Oral azithromycin and standard treatment. Control group: receiving standard treatment alone.
Main outcome variables
Spirometric parameters; evaluation of recovery and control of COPD using CAT and MMRC questionnaires.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210405050849N1
Registration date: 2021-05-28, 1400/03/07
Registration timing: prospective

Last update: 2021-05-28, 1400/03/07
Update count: 0
Registration date
2021-05-28, 1400/03/07
Registrant information
Name
Ebrahim Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
st-abbasi.e@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Adding Azithromycin to Standard Outpatient and Inpatient COPD Treatment in Shahrekord University of Medical Sciences Hospitals
Public title
Evaluation of the effect of oral azithromycin on COPD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of COPD by an internal medicine physician, based on the classification of global pioneers of chronic obstructive pulmonary disease (GOLD) No other chronic diseases such as orthopedic and motor diseases, multiple sclerosis or cancer. hospitalization stability of the patient's physical and mental condition
Exclusion criteria:
Lack of motivation of the patient to cooperation Immune system defects (recurrent respiratory infections and worsening of shortness of breath) Existence of concomitant asthma Complications of azithromycin non-pulmonary diseases like cancer; liver dysfunction, cholestatic jaundice, Infiltration and consolidation in chest x-ray Patients with acute exacerbation of COPD Existence of atopy or allergic rhinitis pneumonia embolism Kidney failure hearing loss
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using the block method by a person who is not related to the study. Randomization of serial numbers of drug packages and placebo is done by a person who is not involved in the project and using a randomization table. The number of each package corresponds to the number of study patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The two-way study is blind. Outcome assessors and participants are unaware of the type of grouping (intervention or placebo) (double-blind). Packages containing the drug and placebo are quite similar in shape and color.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
IR.SKUMS.REC.1399.109

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
FEV1/ FVC
Timepoint
Two months after starting the study
Method of measurement
Spirometry

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Patients in the control group receive conventional therapy (triple therapy) and placebo. Triple therapy includes inhaled anticholinergics (long-acting, short-acting), inhaled bronchodilators (long-acting, short-acting), ICS ± oral corticosteroids (for two weeks).
Category
Treatment - Drugs

2

Description
Intervention group: In this group, in addition to triple therapy, patients are treated with oral azithromycin 250 mg daily made by Tehran Shimi Company for 2 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital, Shahrekord
Full name of responsible person
Akbar Soleimani
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-abbasi.e@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghy
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-abbasi.e@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ebrahim Abbasi Monjezi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar aven
City
Sahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-abbasi.e@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ebrahim Abbasi Monjezi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar Aven.Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-abbasi.e@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ebrahim Abbasi Monjezi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar aven
City
Sahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-abbasi.e@skums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
2021-2022
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document
I have not decided yet
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