Protocol summary

Summary
Tuberculosis (TB) is one of the main causes of death in the world, especially Asia. Much morbidity and mortality due to tuberculosis occur in developing countries which smoking it is very common in them. New research on various aspects of the relationship between smoking and tuberculosis protests has shown effect of smoking on clinical, bacteriological, treatment and recurrence of tuberculosis. Therefore, smoking is a significant risk factor for tuberculosis and tobacco control, so it is recommended to include smoke cessation intervention as a preventive intervention in tuberculosis control programs. This Randomized Clinical trial (RCT) will be conducted during 3 years at National Research Institute of Tuberculosis and Lung Disease (NRITLD) in Tehran. During the study, approximately 60 patients in each group should be studied. Thus, in total, 240 patients (60 patients in each arm) will be evaluated for this study.Patients will be randomly selected among new TB diagnosed Cases, who will be treated by DOTS regime. Smoking evaluation and cessation Counseling and will be offered to the Patients by Physician trained in Smoke Cessation. Patients will be divided randomly in to the intervention group and will receive related smoke cessation intervention. Patients will be followed for Smoke Cessation result at the end of second week, second, quarter and Sixth months. Immunologic evaluation included measurement of cytokine (IL-8) and Fogocytosis will be done at base line and at the end of fourth month. TB Treatment assessment will be done at the end of second, fourth and sixth months, base on negative sputum smear, in all of the study groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013062613783N1
Registration date: 2013-08-31, 1392/06/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-31, 1392/06/09
Registrant information
Name
Mahshid Aryanpur
Name of organization / entity
National Research Institute of Tuberculosis and Lung Disease
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9508
Email address
mahshidaryanpur@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining efficacy of smoke cessation program on quit Rate, immunological response and treatment outcome in new pulmonary tuberculosis patients: a clinical trial
Public title
Determining efficacy of smoke cessation on tuberculosis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: current manufactured cigarette smokers will be diagnosed with active pulmonary TB: either sputum smear-positive or smear-negative, based on classification from WHO treatment guidelines; classify under treatment Category I (new TB cases) ; patients of both sexes, aged 18 years and above; speaking the Persian language. Exclusion criteria: having extra pulmonary TB only (involving CNS, pericardium, adrenal etc) ; they have multi-drug resistant tuberculosis at diagnosis ; they are living with or newly diagnosed with HIV/AIDS ; they are active IV drug abuser ; they are classified as Category II (relapse, treatment failure, and treatment after default) or Category III (chronic TB) ;they fulfill the eligibility criteria, but unwilling to participate in the study or unable to understand the contents of the informed consent form.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Research Institute of Tuberculosis and lung disease
Street address
Masih Daneshvari Hospital-Daar abad- Niavaran
City
Tehran
Postal code
19569-44413
Approval date
2013-04-30, 1392/02/10
Ethics committee reference number
sbmu1.rec1392.17

Health conditions studied

1

Description of health condition studied
tuberculosis
ICD-10 code
A15
ICD-10 code description
Respiratory tuberculosis, bacteriologically and histologically confirmed

Primary outcomes

1

Description
tuberculosis treatment outcome
Timepoint
2,4,6 months
Method of measurement
sputum smear

Secondary outcomes

1

Description
smoke cessation
Timepoint
2-4-6 months
Method of measurement
urine cotenine test

2

Description
Immunologic response(phagocytes capacity uptake and IL-8 amount)
Timepoint
3 months
Method of measurement
flow cytometry

Intervention groups

1

Description
Intervention group (cessation consultation and pharmacotherapy ): smokers patients with pulmonary tuberculosis who are under Tb DOTS Treatment that recieve smoke cessation program consultation and pharmacotherapy . Cessation consultation consist of advice , assist and arrange .Four counseling sessions will be held during the first two weeks .patients will also receive sustain release Bupropion -150 mg- BD for nine weeks which will be free of charge for them.
Category
Treatment - Drugs

2

Description
Intervention groups(Brief advice counseling): smokers patients with pulmonary tuberculosis who are under Tb DOTS Treatment that receive smoking cessation brief advice for three minute. This group will get a short brief advice; strongly and clearly advice to quit smoking, given the benefits of cessation and linking it with their current disease status by trained physician during their TB treatment in the first visit.
Category
Behavior

3

Description
Smoker Control Groups: smoker patients with pulmonary tuberculosis which are under Tb Treatment and age and sex of them are matched with intervention group. They do not receive any intervention.
Category
N/A

4

Description
Non Smoker Control Groups: Non smoker patients with pulmonary tuberculosis which are under Tb Treatment and age and sex of them are matched with intervention group. They do not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
National Research Institute of Tuberculosis and Lung Disease
Full name of responsible person
Mahshid Aryanpur
Street address
Masih Daneshvari Hospital -Daar Abad-Niavaran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Proffesor Mohammad Reza Masjedi
Street address
Daarabad-Niavaran_Tehran
City
Tehran
Grant name
1238006
Grant code / Reference number
1238006
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
National Research Institute of Tuberculosis and Lung Disease
Full name of responsible person
Mahshid Aryanpur
Position
MD-MPH
Other areas of specialty/work
Street address
Masih Daneshvari Hospital -Daar Abad-Niavaran
City
Tehran
Postal code
1955841452
Phone
+98 21 2610 9508
Fax
+98 21 2610 9508
Email
mahshidaryanpur@yahoo.com
Web page address
www.tpcrc.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Disease
Full name of responsible person
Prof. MohammadReza Masjedi
Position
Pulmonary Sun Speciality
Other areas of specialty/work
Street address
Masih Daneshvari Hospital -Daar Abad-Niavaran
City
Tehran
Postal code
1955841452
Phone
+1 9552126109508
Fax
+98 21 2610 9484
Email
mrmasjedi@gmail.com
Web page address
nritld.sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
National Research Institute of Tuberculosis and Lung Disease
Full name of responsible person
Mahshid Aryanpur
Position
MD_MPH
Other areas of specialty/work
Street address
Masih Daneshvari Hospital -Daar Abad-Niavaran
City
تهران
Postal code
1955841452
Phone
+98 21 2610 9508
Fax
+98 21 2610 9508
Email
mahshidaryanpur@yahoo.com
Web page address
www.tpcrc.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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