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

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00315965
• Collaborator: (none)
• Enrollment: 107
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 7.6

Study Details

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
• Anticipated 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: Jul 1, 2006
• Anticipated Study Completion Date: Sep 1, 2007

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

Criteria

• Ages Eligible for Study: 6 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University children´s hospital	Tuebingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00315965
• Other Study ID Numbers: ESNOD-01
• First Posted: Apr 19, 2006
• Last Update Posted: Jun 14, 2007
• Last Verified: May 1, 2007

• Keywords provided by , ,: Diffusion; Membrane diffusing capacity; Alveolar capillary gas diffusion; Transfer factor; Nitric oxide diffusion
• Additional relevant MeSH terms: Nitric Oxide; Carbon Monoxide

Study Results

No Results Posted as of Jun 14, 2007