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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Exhaled particle analysis

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Fraunhofer Institute for Toxicolocy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exhaled particle analysis

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01088633

First Posted

March 12, 2010

Last Updated

September 12, 2023

Sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01088633

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exhaled particle analysis

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Exhaled particle analysis

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

within one day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jens Hohlfeld, Prof. Dr.

Organizational Affiliation

Fraunhofer Institute for Toxicology and Experimental Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fraunhofer Institute for Toxicolocy

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30623

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.atemwegsforschung.de

Description

Related Info

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

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