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

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Drug: nicotine replacement therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences, Ansari Nagar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Nicogum 2mg Cipla pharmaceuticals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Change in TB Score at second month and sixth month	Composite score for objective and subjective improvement measured at baseline, second month and sixth month	Measured at baseline, second month and sixth month.
Sputum culture conversion	Sputum culture conversion at second month using solid/liquid culture technique	Measured at baseline and second month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sputum smear conversion	Protocol was amended to access sputum conversion weekly up to second month	Measured at baseline, second week, fourth week, second month and sixth months
Mortality at sixth month	To determine number of mortality at the end of follow-up	Sixth month
More than 10% weight gain at six months	To determine rate of weight gain after completion of treatment	Sixth month
Proportion of subjects in each group that have quit smoking at second month	To determine the rate of smoking cessation in the cohort	Sixth month
Treatment completion		Six months for new cases and eight months for re-treatment cases following regimen 2
Cure, failure and default rate	To determine cure, failure and default rate in the cohort	At sixth month

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborators: University of Cape Town; Sri Venkateswara Institute of Medical Sciences University
• Investigators: Principal Investigator: Surendra K Sharma, MD, Ph.D., AIIMS, New Delhi

Publications and helpful links

General Publications

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: smoking cessation; early sputum smear conversion
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: SKS/Med/NI1161