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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01517022
First received: June 23, 2011
Last updated: June 21, 2016
Last verified: June 2016

June 23, 2011
June 21, 2016
November 2010
February 2016   (final data collection date for primary outcome measure)
  • 1. Change in TB Score at second month and sixth month [ Time Frame: Measured at baseline, second month and sixth month. ] [ Designated as safety issue: No ]
    Composite score for objective and subjective improvement measured at baseline, second month and sixth month
  • Sputum culture conversion [ Time Frame: Measured at baseline and second month ] [ Designated as safety issue: No ]
    Sputum culture conversion at second month using solid/liquid culture technique
sputum smear conversion [ Time Frame: 2 weeks to 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01517022 on ClinicalTrials.gov Archive Site
  • Sputum smear conversion [ Time Frame: Measured at baseline, second week, fourth week, second month and sixth months ] [ Designated as safety issue: No ]
    Protocol was amended to access sputum conversion weekly up to second month
  • Mortality at sixth month [ Time Frame: Sixth month ] [ Designated as safety issue: No ]
    To determine number of mortality at the end of follow-up
  • More than 10% weight gain at six months [ Time Frame: Sixth month ] [ Designated as safety issue: No ]
    To determine rate of weight gain after completion of treatment
  • Proportion of subjects in each group that have quit smoking at second month [ Time Frame: Sixth month ] [ Designated as safety issue: No ]
    To determine the rate of smoking cessation in the cohort
  • Treatment completion [ Time Frame: Six months for new cases and eight months for re-treatment cases following regimen 2 ] [ Designated as safety issue: No ]
  • Cure, failure and default rate [ Time Frame: At sixth month ] [ Designated as safety issue: No ]
    To determine cure, failure and default rate in the cohort
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Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis
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).

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

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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Study participants will be selected from group of sputum smear positive category-I or Category-II patients who self report to smoke more than 10 cigarette/bidis per day.
Tuberculosis
Drug: nicotine replacement therapy
nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
Other Name: Nicogum 2mg Cipla pharmaceuticals
  • Control arm
    Control arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along with routine DOTS treatment
  • Cessation 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
    Intervention: Drug: nicotine replacement therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
September 2016
February 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01517022
SKS/Med/NI1161
Yes
Not Provided
Not Provided
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
  • University of Cape Town
  • Sri Venkateswara Institute of Medical Sciences University
Principal Investigator: Surendra K Sharma, MD, Ph.D. AIIMS, New Delhi
All India Institute of Medical Sciences, New Delhi
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP