Clinical trial NCT01088633: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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:

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

Primary outcomes:
measure: Characterization of particles in exhaled breath of subjects with COPD compared with healthy smokers.
timeFrame: within one day
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Fraunhofer Institute for Toxicolocy
state: Niedersachsen
Study officials:
affiliation: Fraunhofer Institute for Toxicology and Experimental Medicine
name: Jens Hohlfeld, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: