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

This study has been completed.
Sponsor:
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT01088633
First received: March 12, 2010
Last updated: February 8, 2011
Last verified: February 2011
History of Changes

March 12, 2010
February 8, 2011
March 2010
September 2010   (final data collection date for primary outcome measure)
Characterization of particles in exhaled breath of subjects with COPD compared with healthy smokers. [ Time Frame: within one day ] [ Designated as safety issue: No ]

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.
Same as current
Complete list of historical versions of study NCT01088633 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Chronic Obstructive Pulmonary Disease
Other: Exhaled particle analysis

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.
Exhaled particle analysis
Intervention: Other: Exhaled particle analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01088633
10/05 AEROC
No
Prof. Dr. Jens Hohlfeld, Fraunhofer-Institute of Toxicology and Experimental Medicine
Fraunhofer-Institute of Toxicology and Experimental Medicine
Not Provided
Principal Investigator: Jens Hohlfeld, Prof. Dr. Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer-Institute of Toxicology and Experimental Medicine
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP