Clinical trial NCT03562442: SAW Lung Microbiome Study in Smokers and Never-smokers
Official title: Leibniz Association Senate Board of Competition (SAW) Lung Microbiome Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Chronic Obstructive Pulmonary Disease (COPD)
Healthy
Microbial Colonization
Lead sponsor: Research Center Borstel
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Cigarette consumption of at least five cigarettes per day
* Caucasian ethnicity

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Change in microbiome pattern in smokers after smoking cessation
timeFrame: 6 Weeks
Secondary outcomes:
measure: Smoking cessation rates
timeFrame: 6 weeks
measure: Smoking cessation rates
timeFrame: 6 months
measure: Lung microbiome in never-smokers
timeFrame: 0 days
Other outcomes:
Locations:
city: Borstel
country: Germany
facility: Research Center Borstel
state: Schleswig-Holstein
Study officials:
References:
citation: 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.