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

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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:
University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE April 17, 2006
First Posted Date  ICMJE April 19, 2006
Last Update Posted Date June 14, 2007
Study Start Date  ICMJE July 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2006)
  • TLNOss
  • TLCOsb
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00315965 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2006)
  • Breathing frequency
  • tidal volume
  • functional residual capacity
  • airway resistance
  • lung clearance index
  • forced expiratory volume in one second
  • vital capacity
  • total lung capacity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects
Official Title  ICMJE Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pulmonary Diffusing Capacity
Intervention  ICMJE Drug: Nitric oxide, Carbon monoxide, Helium
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 17, 2006)
107
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00315965
Other Study ID Numbers  ICMJE ESNOD-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tobias Pantalitschka, MD University Hospital Tuebingen, Germany
PRS Account University Hospital Tuebingen
Verification Date May 2007

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