Characterization of Aerosol Generation and Transport in t... | NCT01088633

Status Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Exhaled particle analysis	Other		Other: Exhaled particle analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exhaled particle analysis	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	within one day

Eligibility Module

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

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms