Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study is aiming at evaluating the characteristics of particle emission in subjects with different stages of chronic obstructive pulmonary disease (COPD) compared with healthy smokers.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fraunhofer Institute for Toxicolocy

Hanover, Lower Saxony, 30623, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female subjects, aged ≥ 18 years
COPD: Physician diagnosis of chronic obstructive pulmonary disease (COPD GOLD I to IV according to GOLD guidelines)9
Healthy smokers: current smokers with a history of at least 10 packyears and no signs of bronchial obstruction in spirometry (FEV1 >= 80% pred, FEV1/FVC >= 70%)
Able and willing to give written informed consent
Women will be considered for inclusion if they are:

not pregnant, as confirmed by pregnancy test, and not nursing
of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit)
of childbearing potential and using a highly effective method of contraception during the entire study (vasectomized partner, sexual abstinence) - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the study until at least 72 hours after the end of the study , implants, injectables, combined oral contraceptives, hormonal IUDs, or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap)
Available to complete all study measurements

Exclusion criteria

History of lower respiratory tract infection four weeks prior to the informed consent visit
Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to tuberculosis, bronchiectasis or cystic fibrosis)
History of drug or alcohol abuse
Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
Inability to abstain from bronchodilators according to section 8.2 (Prohibited medication)
Risk of non-compliance with study procedures

Treatment and study plan

Exhaled particle analysis

Other

At visit 2, the exhaled particle analysis will be performed. Subjects will be asked to breath through the device and to perform several breathing maneuvers such as deep breathing, shallow breathing, rapid breathing, slow breathing. These measurements will be repeated after 2 hours on the same day.

Visit 3:

After a baseline exhaled particle analysis, the subjects will inhale nebulized saline (2.5 ml of a 0.9 % NaCl-solution). Aerosol generation and transport will be recorded immediately after the end of inhalation as well as 2 hours and 4 hours after the start of inhalation using the same techniques as in visit 2.

Primary outcomes

Characterization of particles in exhaled breath of subjects with COPD compared with healthy smokers.

Time frame: within one day

At visit 2, the exhaled particle analysis will be performed. These measurements will be repeated after 2 hours on the same day.

Visit 3:

After a baseline exhaled particle analysis, the subjects will inhale nebulized saline (2.5 ml of a 0.9 % NaCl-solution). Aerosol generation and transport will be recorded immediately after the end of inhalation as well as 2 hours and 4 hours.

Sponsors and collaborators

Lead sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

Other

Registry information

Official study title

Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Mar 17, 2010
Registry last updated: Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed