Smoking CessationNCT03562442
SAW Lung Microbiome Study in Smokers and Never-smokers
A study testing Smoking cessation in people with Smoking Cessation and Chronic Obstructive Pulmonary Disease (COPD), run by Research Center Borstel at 1 site in Germany.
Trial summary
The trial aims to analyse changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in smokers before and 6 weeks after smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Chronic Obstructive Pulmonary Disease (COPD), Healthy
- What is being tested?
- Smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 29 Mar 2017to 1 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cigarette consumption of at least five cigarettes per day
- Caucasian ethnicity
Who cannot join
- Continous passive smoking exposure
- Systemic steroid therapy during the previous month
- Chronic lung disease (exception COPD stage Global Initiative on Lung Disease (GOLD) 0/I/II)
- Diabetes mellitus
- Pregnancy or breast feeding
- active tuberculosis (currently or previously)
Show all 13Show fewer
- respiratory infection in the previous month
- antibiotic therapy in the previous two months
- immunosuppression
- malignancy
- interstitial lung disease
- rheumatic disease with lung manifestation
- member of a collaborative group of the project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leibniz Association Senate Board of Competition (SAW) Lung Microbiome Study
The trial aims to analyse changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.
Read the detailed description
The trial aims to analyze changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in healthy (and willing to quit) smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.
Demographic and clinical data of the study subjects are obtained, aiming for homogeneous groups. All personal data are encrypted according to the standard operating procedures of the study site. Pharyngeal and deep nasal swabs are taken.
To avoid contamination of the lower airways from the oropharynx through the bronchoscope, standardized procedures are established according to the German guidelines for bronchoscopy. Before bronchoscopy, the endoscope is flushed with sterile saline which is analyzed for 16S ribosomal RNA (rRNA) to control for residual contaminating bacterial desoxyribonucleic acid (DNA). A 300ml bronchoalveolar lavage with warm normal saline solution is taken from the middle lobe. Three covered and "microbiologically protected" bronchial brushings are obtained from the right upper lobe. This sterile brush is sealed in wax and pushed through the wax just before taking the brushing. All samples are immediately frozen and stored at -80°C until further analyses. For cultivations, samples are kept at 4°C and rapidly processed.
- Conditions
- Smoking Cessation, Chronic Obstructive Pulmonary Disease (COPD), Healthy, Microbial Colonization
- Being tested
- Smoking cessation
- Medical subject headings
- Smoking Cessation, Pulmonary Disease, Chronic Obstructive, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessationBehavioural
Smoking cessation with or without professional / medical support
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Experimental | Healthy caucasian smokers who are willing to quit smoking are investigated before cessation (Visit 1) and 6 weeks after cessation (Visit 2).
Intervention: Smoking cessation Receives: Behavioral: Smoking cessation |
| Never-Smokers | No intervention | Healthy caucasian volunteers who never smoked are investigated once only (Visit 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiome pattern in smokers after smoking cessation
Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture
Measured: 6 Weeks
Secondary outcomes (3)
Smoking cessation rates
Percentage of sustained smoking cessation
Measured: 6 weeks
Smoking cessation rates
Percentage of sustained smoking cessation
Measured: 6 months
Lung microbiome in never-smokers
Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start29 Mar 2017
- Primary completion31 Dec 2019
- Study completion1 Mar 2020
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 Smoking CessationStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups are recruited in parallel (A) Smokers who quit smoking (Visit 1 before cessation, Visit 2 six weeks after cessation) (B) Never-smokers (Visit 1 only)
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562442
- Sponsor's protocol ID
- SAW Lungenmikrobiom-Studie
- Status last verified
- Apr 2024
- First submitted
- 26 May 2018
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pfeiffer S, Herzmann C, Gaede KI, Kovacevic D, Krauss-Etschmann S, Schloter M. Different responses of the oral, nasal and lung microbiomes to cigarette smoke. Thorax. 2022 Feb;77(2):191-195. doi: 10.1136/thoraxjnl-2020-216153. Epub 2021 Aug 13.
PubMed 34389656
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leibniz Association Senate Board of Competition (SAW) Lung Microbiome Study
- ClinicalTrials.gov ID
- NCT03562442
- Acronym / sponsor ID
- SAW Lungenmikrobiom-Studie
- Conditions
- Smoking Cessation, Chronic Obstructive Pulmonary Disease (COPD), Healthy, Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Research Center BorstelUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 19 Jun 2018 (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.
The trial aims to analyse changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.
Detailed description
The trial aims to analyze changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in healthy (and willing to quit) smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.
Demographic and clinical data of the study subjects are obtained, aiming for homogeneous groups. All personal data are encrypted according to the standard operating procedures of the study site. Pharyngeal and deep nasal swabs are taken.
To avoid contamination of the lower airways from the oropharynx through the bronchoscope, standardized procedures are established according to the German guidelines for bronchoscopy. Before bronchoscopy, the endoscope is flushed with sterile saline which is analyzed for 16S ribosomal RNA (rRNA) to control for residual contaminating bacterial desoxyribonucleic acid (DNA). A 300ml bronchoalveolar lavage with warm normal saline solution is taken from the middle lobe. Three covered and "microbiologically protected" bronchial brushings are obtained from the right upper lobe. This sterile brush is sealed in wax and pushed through the wax just before taking the brushing. All samples are immediately frozen and stored at -80°C until further analyses. For cultivations, samples are kept at 4°C and rapidly processed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups are recruited in parallel (A) Smokers who quit smoking (Visit 1 before cessation, Visit 2 six weeks after cessation) (B) Never-smokers (Visit 1 only)
| Arm | Type | Receives |
|---|---|---|
| Smokers | Experimental | Behavioral: Smoking cessationHealthy caucasian smokers who are willing to quit smoking are investigated before cessation (Visit 1) and 6 weeks after cessation (Visit 2). Intervention: Smoking cessation |
| Never-Smokers | No intervention | –Healthy caucasian volunteers who never smoked are investigated once only (Visit 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cigarette consumption of at least five cigarettes per day
- Caucasian ethnicity
Key exclusion criteria (13 listed)
- Continous passive smoking exposure
- Systemic steroid therapy during the previous month
- Chronic lung disease (exception COPD stage Global Initiative on Lung Disease (GOLD) 0/I/II)
- Diabetes mellitus
- Pregnancy or breast feeding
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 |
|---|---|---|
| Smoking cessationSmoking cessation with or without professional / medical support | Behavioural | Smokers |
Primary outcome
Change in microbiome pattern in smokers after smoking cessation
Time frame: 6 Weeks
Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture
3 secondary outcomes
Smoking cessation rates
Time frame: 6 weeks
Smoking cessation rates
Time frame: 6 months
Lung microbiome in never-smokers
Time frame: 0 days
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 17 Apr 2024.
- Derived from this study: PubMed 34389656Pfeiffer S, Herzmann C, Gaede KI, Kovacevic D, Krauss-Etschmann S, Schloter M. Different responses of the oral, nasal and lung microbiomes to cigarette smoke. Thorax. 2022 Feb;77(2):191-195. doi: 10.1136/thoraxjnl-2020-216153. Epub 2021 Aug 13.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation in people with Smoking Cessation and Chronic Obstructive Pulmonary Disease (COPD), run by Research Center Borstel at 1 site in Germany.
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 2 inclusion and 13 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 17 Apr 2024. 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 Germany. 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?
Change in microbiome pattern in smokers after smoking cessation (time frame: 6 Weeks). 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 NCT03562442, 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 17 Apr 2024.