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Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00315965
Recruitment Status : Unknown
Verified May 2007 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : April 19, 2006
Last Update Posted : June 14, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Using a rapidly responding nitric oxide analyzer in a new developed modular lung-function-setup we are going to measure steady-state NO diffusing capacity in 107 healthy subjects (age 6-45 years). The results will be compared to those measured by using carbon monoxide single-breath estimates. We like to show that the new method is sufficient to measure exactly lung diffusion capacity in this collective.

Condition or disease Intervention/treatment Phase
Pulmonary Diffusing Capacity Drug: Nitric oxide, Carbon monoxide, Helium Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects
Study Start Date : July 2006
Estimated Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. TLNOss
  2. TLCOsb

Secondary Outcome Measures :
  1. Breathing frequency
  2. tidal volume
  3. functional residual capacity
  4. airway resistance
  5. lung clearance index
  6. forced expiratory volume in one second
  7. vital capacity
  8. total lung capacity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Lung function testing possible
  • Written consent

Exclusion Criteria:

  • Pulmonary, neuromuscular, cardiovascular, endocrinological illness
  • Pregnancy
  • Abuse of nicotine, alcohol, drugs during the last two years
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315965


Contacts
Contact: Tobias Pantalitschka, MD +49 70712984711 tobias.pantalitschka@med.uni-tuebingen.de

Locations
Germany
University children´s hospital Recruiting
Tuebingen, Germany, 72076
Contact: Tobias Pantalitschka, MD    +49 7071 2984711    tobias.pantalitschka@med.uni-tuebingen.de   
Principal Investigator: Tobias Pantalitschka, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Tobias Pantalitschka, MD University Hospital Tuebingen, Germany
More Information

ClinicalTrials.gov Identifier: NCT00315965     History of Changes
Other Study ID Numbers: ESNOD-01
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: June 14, 2007
Last Verified: May 2007

Keywords provided by University Hospital Tuebingen:
Diffusion
Membrane diffusing capacity
Alveolar capillary gas diffusion
Transfer factor
Nitric oxide diffusion

Additional relevant MeSH terms:
Nitric Oxide
Carbon Monoxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents
Antimetabolites