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
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Exhaled particle analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 70
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exhaled particle analysis 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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088633

Locations
Germany
Fraunhofer Institute for Toxicolocy
Hannover, Niedersachsen, Germany, 30623
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
Investigators
Principal Investigator: Jens Hohlfeld, Prof. Dr. Fraunhofer Institute for Toxicology and Experimental Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Jens Hohlfeld, Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier: NCT01088633     History of Changes
Other Study ID Numbers: 10/05 AEROC
Study First Received: March 12, 2010
Last Updated: February 8, 2011
Health Authority: Germany: German Institute of Medical Documentation and Information
Germany: Ethics Commission

Keywords provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014