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CompletedNCT01088633Updated Sep 14, 2023

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

An interventional study of Exhaled particle analysis in Chronic Obstructive Pulmonary Disease, sponsored by Fraunhofer-Institute of Toxicology and Experimental Medicine. Completed at 1 site in Germany. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by Fraunhofer-Institute of Toxicology and Experimental Medicine · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 74 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
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In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine is the lead sponsor of 37 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects, aged ≥ 18 years
  2. COPD: Physician diagnosis of chronic obstructive pulmonary disease (COPD GOLD I to IV according to GOLD guidelines)9
  3. 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%)
  4. Able and willing to give written informed consent
  5. 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)
  6. Available to complete all study measurements

Exclusion criteria

Exclusion Criteria:

  1. History of lower respiratory tract infection four weeks prior to the informed consent visit
  2. 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)
  3. History of drug or alcohol abuse
  4. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
  5. Inability to abstain from bronchodilators according to section 8.2 (Prohibited medication)
  6. Risk of non-compliance with study procedures
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    Exhaled particle analysis

    Other: Exhaled particle analysis

Interventions

  • OtherExhaled particle analysis

    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.

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What researchers measure

Primary outcomes

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

    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.

    Time frame: within one day

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Study locations

1 site
  • Fraunhofer Institute for Toxicolocy
    Hanover, Lower Saxony 30623, Germany
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References and documents

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01088633
Lead sponsor
Fraunhofer-Institute of Toxicology and Experimental Medicine
Responsible party
Prof. Dr. Jens Hohlfeld, MD (Division director, Fraunhofer-Institute of Toxicology and Experimental Medicine) — Principal investigator
First posted
Mar 17, 2010
Start date
Mar 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Sep 14, 2023

Study contacts

Jens Hohlfeld, Prof. Dr.
principal investigator · Fraunhofer Institute for Toxicology and Experimental Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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