Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 3

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
    

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).
    

Intervention name(s): nicotine replacement therapy
Intervention type(s): Drug
Intervention description(s): nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
Other intervention name(s): Nicogum 2mg Cipla pharmaceuticals
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: smoking cessation; early sputum smear conversion