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

June 13, 2007 updated by: University Hospital Tuebingen
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

107

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Recruiting
        • University children´s hospital
        • Contact:
        • Principal Investigator:
          • Tobias Pantalitschka, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
TLNOss
TLCOsb

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Tobias Pantalitschka, MD, University Hospital Tuebingen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Anticipated)

September 1, 2007

Study Registration Dates

First Submitted

April 17, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (Estimate)

April 19, 2006

Study Record Updates

Last Update Posted (Estimate)

June 14, 2007

Last Update Submitted That Met QC Criteria

June 13, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESNOD-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Diffusing Capacity

Clinical Trials on Nitric oxide, Carbon monoxide, Helium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe