Tuberculosis, PulmonaryNCT04848246
Effect of Smoking Cessation on Tuberculosis Treatment Outcomes
A study testing Bupropion and Behavioural Change Communication in people with Tuberculosis, Pulmonary, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This study was a Randomized Controlled Trial conducted at Ojha Institute of Chest Diseases, Dow University of Health Sciences, Karachi, among pulmonary tuberculosis patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Bupropion and Behavioural Change Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Nov 2017to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pulmonary tuberculosis patients of age 18 years or above
- registered under Directly Observed Treatment Short course (DOTS) at Ojha Institute of Chest Diseases
- reported to have smoked 100 plus cigarettes in past and currently smoking cigarettes
Who cannot join
- Extra pulmonary tuberculosis
- drug resistant tuberculosis
- pregnancy
- positive history of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Smoking Cessation Interventions on Tuberculosis Treatment Outcomes Among Newly Diagnosed Pulmonary Tuberculosis Patients; a Single Blind Randomized Controlled Trial
This study was a Randomized Controlled Trial conducted at Ojha Institute of Chest Diseases, Dow University of Health Sciences, Karachi, among pulmonary tuberculosis patients
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Bupropion, Behavioural Change Communication
- Keywords
- smoking cessation
- Medical subject headings
- Tuberculosis, Pulmonary, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
This group received Bupropion 150 mg twice daily for 10 weeks
Behavioural Change CommunicationBehavioural
This group will receive Behavioural Change Communication
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Experimental | Not described Receives: Drug: Bupropion; Behavioral: Behavioural Change Communication |
| Behavioural Change Communication | Experimental | Not described Receives: Behavioral: Behavioural Change Communication |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients completing anti-tuberculosis treatment
Among both smear positive and smear negative TB patients, successful completion of ATT will be labeled at the end of 6 months period if the patients has been compliant with ATT through six months period..
Measured: six months
Secondary outcomes (1)
Percentage of participants achieving abstinence from smoking
Abstinence is defined as staying away from smoking and it will be assessed at week 1, week 4, week 12 and week 24 will be assessed in following two ways:
- Self-reported abstinence using questionnaire ii. Expired carbon monoxide (eCO) levels using Micro Smokerlyzer (Bedfont Scientific) of less than 7 ppm.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start6 Nov 2017
- Primary completion30 Sep 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of three groups, two intervention and one control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Tahir Rizwan Khan, Dow University of Health Sciences
- Investigators
- Muhammad Tahir Rizwan Khan, M.Phil., Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848246
- Sponsor's protocol ID
- IRB-898/DUHS/Approval/2017/136
- Status last verified
- Apr 2021
- First submitted
- 4 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan MT, Zaheer S, Amar W, Shafique K. Effect of smoking cessation interventions on abstinence and tuberculosis treatment outcomes among newly diagnosed patients: a randomized controlled trial. Microbiol Spectr. 2024 Apr 2;12(4):e0387823. doi: 10.1128/spectrum.03878-23. Epub 2024 Feb 22.
PubMed 38385711
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Smoking Cessation Interventions on Tuberculosis Treatment Outcomes Among Newly Diagnosed Pulmonary Tuberculosis Patients; a Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04848246
- Acronym / sponsor ID
- IRB-898/DUHS/Approval/2017/136
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a Randomized Controlled Trial conducted at Ojha Institute of Chest Diseases, Dow University of Health Sciences, Karachi, among pulmonary tuberculosis patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A total of three groups, two intervention and one control
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Experimental | Drug: Bupropion, Behavioral: Behavioural Change Communication |
| Behavioural Change Communication | Experimental | Behavioral: Behavioural Change Communication |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pulmonary tuberculosis patients of age 18 years or above
- registered under Directly Observed Treatment Short course (DOTS) at Ojha Institute of Chest Diseases
- reported to have smoked 100 plus cigarettes in past and currently smoking cigarettes
Key exclusion criteria (4 listed)
- Extra pulmonary tuberculosis
- drug resistant tuberculosis
- pregnancy
- positive history of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionThis group received Bupropion 150 mg twice daily for 10 weeks | Drug | Bupropion |
| Behavioural Change CommunicationThis group will receive Behavioural Change Communication | Behavioural | Behavioural Change Communication, Bupropion |
Primary outcome
Percentage of patients completing anti-tuberculosis treatment
Time frame: six months
Among both smear positive and smear negative TB patients, successful completion of ATT will be labeled at the end of 6 months period if the patients has been compliant with ATT through six months period..
1 secondary outcome
Percentage of participants achieving abstinence from smoking
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 38385711Khan MT, Zaheer S, Amar W, Shafique K. Effect of smoking cessation interventions on abstinence and tuberculosis treatment outcomes among newly diagnosed patients: a randomized controlled trial. Microbiol Spectr. 2024 Apr 2;12(4):e0387823. doi: 10.1128/spectrum.03878-23. Epub 2024 Feb 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Tahir Rizwan Khan, M.Phil. principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupropion and Behavioural Change Communication in people with Tuberculosis, Pulmonary, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients completing anti-tuberculosis treatment (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04848246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.