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
  Purpose

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 Intervention Phase
Tuberculosis
Drug: nicotine replacement therapy
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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).

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 800
Study Start Date: November 2010
Estimated Study Completion Date: September 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Drug: nicotine replacement therapy
nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
Other Name: Nicogum 2mg Cipla pharmaceuticals

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).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517022

Locations
India
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
Investigators
Principal Investigator: Surendra K Sharma, MD, Ph.D. AIIMS, New Delhi
  More Information

Responsible Party: S.K.SHARMA, Professor and Haed, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01517022     History of Changes
Other Study ID Numbers: SKS/Med/NI1161 
Study First Received: June 23, 2011
Last Updated: June 21, 2016
Health Authority: India: Indian Council of Medical Research

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

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Nicotine
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

ClinicalTrials.gov processed this record on July 27, 2016