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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00315965
First received: April 17, 2006
Last updated: June 13, 2007
Last verified: May 2007
  Purpose

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 Intervention Phase
Pulmonary Diffusing Capacity
Drug: Nitric oxide, Carbon monoxide, Helium
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • TLNOss
  • TLCOsb

Secondary Outcome Measures:
  • Breathing frequency
  • tidal volume
  • functional residual capacity
  • airway resistance
  • lung clearance index
  • forced expiratory volume in one second
  • vital capacity
  • total lung capacity

Estimated Enrollment: 107
Study Start Date: July 2006
Estimated Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   6 Years to 45 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00315965     History of Changes
Other Study ID Numbers: ESNOD-01
Study First Received: April 17, 2006
Last Updated: June 13, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on October 20, 2014