Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

12 ottobre 2017 aggiornato da: S.K.SHARMA, All India Institute of Medical Sciences, New Delhi

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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

800

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control arm
Control arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along with routine DOTS treatment
Comparatore attivo: 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
nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
Altri nomi:
  • Nicogum 2mg Cipla pharmaceuticals

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
1. Change in TB Score at second month and sixth month
Lasso di tempo: Measured at baseline, 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
Lasso di tempo: Measured at baseline and second month
Sputum culture conversion at second month using solid/liquid culture technique
Measured at baseline and second month

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sputum smear conversion
Lasso di tempo: Measured at baseline, second week, fourth week, second month and sixth months
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
Lasso di tempo: Sixth month
To determine number of mortality at the end of follow-up
Sixth month
More than 10% weight gain at six months
Lasso di tempo: Sixth month
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
Lasso di tempo: Sixth month
To determine the rate of smoking cessation in the cohort
Sixth month
Treatment completion
Lasso di tempo: Six months for new cases and eight months for re-treatment cases following regimen 2
Six months for new cases and eight months for re-treatment cases following regimen 2
Cure, failure and default rate
Lasso di tempo: At sixth month
To determine cure, failure and default rate in the cohort
At sixth month

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Surendra K Sharma, MD, Ph.D., AIIMS, New Delhi

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2010

Completamento primario (Effettivo)

1 settembre 2016

Completamento dello studio (Effettivo)

1 settembre 2016

Date di iscrizione allo studio

Primo inviato

23 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

20 gennaio 2012

Primo Inserito (Stima)

25 gennaio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 ottobre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 ottobre 2017

Ultimo verificato

1 ottobre 2017

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Tubercolosi

Prove cliniche su nicotine replacement therapy

Sottoscrivi