SAW Lung Microbiome Study in Smokers and Never-smokers

NCT03562442 | Completed

• 1 other identifier: SAW Lungenmikrobiom-Studie
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in microbiome pattern in smokers after smoking cessation

  Number of bacteria genera in the lung identified by 16S rRNA and bacterial culture

  6 Weeks

Secondary Outcomes (3)

• Smoking cessation rates

  6 weeks

• Smoking cessation rates

  6 months

• Lung microbiome in never-smokers

  0 days

Study Arms (2)

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

Behavioral: Smoking cessation

Never-Smokers

NO INTERVENTION

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

Interventions

Smoking cessation BEHAVIORAL

Smoking cessation with or without professional / medical support

Smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Center Borstel: lead

Study Sites (1)

Research Center Borstel

Borstel, Schleswig-Holstein, 23845, Germany

Location

Related Publications (1)

• 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.

  PMID: 34389656 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Pulmonary Disease, Chronic Obstructive; Communicable Diseases

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 19, 2018
• Study Start: March 29, 2017
• Primary Completion: December 31, 2019
• Study Completion: March 1, 2020
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)