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

Pulmonary Diffusing Capacity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00315965
• Other study ID #: ESNOD-01
• Status: Recruiting
• Phase: Phase 1
• First received: April 17, 2006
• Last updated: June 13, 2007
• Start date: July 2006
• Est. completion date: September 2007

Study information

• Verified date: May 2007
• Source: University Hospital Tuebingen
• Contact: Tobias Pantalitschka, MD
• Phone: +49 70712984711
• Email: tobias.pantalitschka[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 107
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pulmonary Diffusing Capacity

Intervention

Drug:
• Nitric oxide, Carbon monoxide, Helium

Locations

Country	Name	City	State
Germany	University children´s hospital	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TLNOss
Primary	TLCOsb
Secondary	Breathing frequency
Secondary	tidal volume
Secondary	functional residual capacity
Secondary	airway resistance
Secondary	lung clearance index
Secondary	forced expiratory volume in one second
Secondary	vital capacity
Secondary	total lung capacity