Chronic Obstructive Pulmonary DiseaseNCT01088633
Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Exhaled particle analysis in people with Chronic Obstructive Pulmonary Disease, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Exhaled particle analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institute for Toxicolocy
Hanover, Lower Saxony, 30623
About this study
Official title: Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Exhaled particle analysis
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled particle analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exhaled particle analysis | Other | Not described Receives: Other: Exhaled particle analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Jens Hohlfeld, MD, Fraunhofer-Institute of Toxicology and Experimental Medicine
- Investigators
- Jens Hohlfeld, Prof. Dr., Principal investigator, Fraunhofer Institute for Toxicology and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088633
- Sponsor's protocol ID
- 10/05 AEROC
- Status last verified
- Sep 2023
- First submitted
- 12 Mar 2010
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01088633
- Acronym / sponsor ID
- 10/05 AEROC
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exhaled particle analysis | Other | Other: Exhaled particle analysis |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exhaled particle analysisAt 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. | Other | Exhaled particle analysis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Hohlfeld, Prof. Dr. principal investigator
Fraunhofer Institute for Toxicology and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exhaled particle analysis in people with Chronic Obstructive Pulmonary Disease, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of particles in exhaled breath of subjects with COPD compared with healthy smokers. (time frame: within one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.