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Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517022
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : October 13, 2017
University of Cape Town
Sri Venkateswara Institute of Medical Sciences University
Information provided by (Responsible Party):
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi

Brief Summary:

The aim of the study is to determine the impact of a package of smoking-cessation interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes.

Given the lack of objective clinical data/evidence about the impact of smoking-cessation on TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to be beneficial particularly in patients with TB, this study proposes to determine the impact of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis therapy. This is to be compared with the structured counselling for smoking-cessation that is recommended to be routinely provided by health care workers to all patients who are smokers. If the results prove that such a smoking-cessation PI indeed improves outcomes in TB patients, such information would strongly motivate for the institution of more intensive smoking-cessation interventions in TB clinics than is currently being employed for TB patients

Condition or disease Intervention/treatment Phase
Tuberculosis Drug: nicotine replacement therapy Phase 3

Detailed Description:
No clinical trials have been done to determine if the cessation of smoking has any influence on outcome in tuberculosis patients. In particular, if smoking cessation leads to a higher rate of sputum culture-conversion at 2 months, TB transmission rates should be reduced. Such targeted smoking-cessation intervention may be more successful than general public education strategies in reducing the spread of TB in high-incidence countries Tuberculosis (TB) . The WHO has estimated that approximately a third of the world's population is infected with Mycobacterium tuberculosis, and approximately 2 million die from TB every year. Tobacco smoking, which is the single most preventable cause of death in the world today, appears to be an important risk factor for TB disease and mortality, especially in countries such as India. The smoking-TB association has major public health implications because in many of the developing countries where there is a high prevalence of TB, smoking is also a common practice. Smoking is widespread, with approximately a third of the global population aged 15 years or above being smokers, but has reached epidemic proportions in countries such as India, China and Russia. For example, in India more than half of the rural male population is estimated to smoke and India accounts for 1.85 million TB cases each year. Therefore in India, as for other developing countries, the co-existence of a high TB and smoking burden is a major health concern, and further underscores the importance of promoting smoking cessation to the general public. In India, studies have shown a strong association between tobacco and TB mortality. An estimated third of male TB deaths in India may be due to smoking. However, there is concern that many of the published studies did not adequately control for bias and confounding (that may have caused spurious associations).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of a Package of Intensive Smoking-cessation Interventions Versus Smoking-cessation Advice on Outcomes in Smear-positive Patients With Pulmonary Tuberculosis; a Randomised Controlled Trial (STB_RCT).
Study Start Date : November 2010
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
No Intervention: Control arm
Control arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along with routine DOTS treatment
Active Comparator: Intervention arm
Cessation arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along and nicotine replacement therapy(NRT) and routine DOTS treatment
Drug: nicotine replacement therapy
nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
Other Name: Nicogum 2mg Cipla pharmaceuticals

Primary Outcome Measures :
  1. 1. Change in TB Score at second month and sixth month [ Time Frame: Measured at baseline, second month and sixth month. ]
    Composite score for objective and subjective improvement measured at baseline, second month and sixth month

  2. Sputum culture conversion [ Time Frame: Measured at baseline and second month ]
    Sputum culture conversion at second month using solid/liquid culture technique

Secondary Outcome Measures :
  1. Sputum smear conversion [ Time Frame: Measured at baseline, second week, fourth week, second month and sixth months ]
    Protocol was amended to access sputum conversion weekly up to second month

  2. Mortality at sixth month [ Time Frame: Sixth month ]
    To determine number of mortality at the end of follow-up

  3. More than 10% weight gain at six months [ Time Frame: Sixth month ]
    To determine rate of weight gain after completion of treatment

  4. Proportion of subjects in each group that have quit smoking at second month [ Time Frame: Sixth month ]
    To determine the rate of smoking cessation in the cohort

  5. Treatment completion [ Time Frame: Six months for new cases and eight months for re-treatment cases following regimen 2 ]
  6. Cure, failure and default rate [ Time Frame: At sixth month ]
    To determine cure, failure and default rate in the cohort

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • any adult (> 18 years)
  • Recently diagnosed (primary TB/Relapse TB) smear-positive TB patient who self-reports to smoke at least 10 whole cigarettes or bidis (rolled tobacco leaf) per day, every day

Exclusion Criteria:

  • patients will be excluded from recruitment to the study if they fall into any one or more of these exclusion categories:

    • Inability to give consent or < 18 years
    • Patients who self-report to smoke less than 10 whole cigarettes/bidis per day
    • TB patients who have already started anti-tuberculosis therapy for more than 1 week.
    • Patients with known multidrug-resistant TB (or XDR) (information provided by patient or the information is available in the clinic folder).
    • Known HIV-positive patients
    • Contra-indications to NRT (patients with a history of severe cardiovascular disease including arrhythmias, recent myocardial infarction (within the last 6 months), recent cerebrovascular incident (6 months), and/ or history of peripheral vascular disease, phaeochromocytoma, poorly controlled diabetes mellitus, hyperthyroidism, renal/hepatic impairment or gastritis/peptic ulcers). Patients with asthma or depression will also be excluded, as quitting may have an effect on medications used for these conditions. Patients with severe skin disorders (such as psoriasis or eczema) will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517022

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All India Institute of Medical Sciences, Ansari Nagar
New Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
University of Cape Town
Sri Venkateswara Institute of Medical Sciences University
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Principal Investigator: Surendra K Sharma, MD, Ph.D. AIIMS, New Delhi

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Responsible Party: S.K.SHARMA, Professor and Head, All India Institute of Medical Sciences, New Delhi Identifier: NCT01517022     History of Changes
Other Study ID Numbers: SKS/Med/NI1161
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by S.K.SHARMA, All India Institute of Medical Sciences, New Delhi:
smoking cessation
early sputum smear conversion

Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action