SAW Lung Microbiome Study in Smokers and Never-smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-29

Study Completion Date

2020-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Diagnostic Measures in Chronic Obstructive Pulmonary Disease (COPD) in Routine Practice and Their Impact on Treatment Decisions

NCT03465332

Pulmonary Disease, Chronic Obstructive

COMPLETED

Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD

NCT02892396

Chronic Obstructive Pulmonary Disease

COMPLETED

Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness Of Breath

NCT00442468

Pulmonary Disease, Chronic Obstructive

COMPLETED

Lung Volume Reduction Coil Microbiome Study

NCT03010566

Chronic Obstructive Pulmonary Disease Emphysema

UNKNOWN

Blood Eosinophil Measurements in Patients With Chronic Obstructive Pulmonary Disease

NCT03853642

Chronic Obstructive Pulmonary Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation Chronic Obstructive Pulmonary Disease (COPD) Healthy Microbial Colonization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Smokers

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

Group Type EXPERIMENTAL

Smoking cessation

Intervention Type BEHAVIORAL

Smoking cessation with or without professional / medical support

Never-Smokers

Healthy caucasian volunteers who never smoked are investigated once only (Visit 1)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Smoking cessation

Smoking cessation with or without professional / medical support

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes