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

Fraunhofer-Institute of Toxicology and Experimental Medicine

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Exhaled particle analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01088633

10/05 AEROC

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Exhaled particle analysis

Other group

Treatment:

Other: Exhaled particle analysis