Development of a New Method for Steady-State Measurement... | NCT00315965

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

NCT00315965

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Jun 14, 2007Estimated

Enrollment

107Estimated

Phase

Phase 1

Conditions

Pulmonary Diffusing Capacity

Interventions

Nitric oxide, Carbon monoxide, Helium

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Sep 2007Estimated

First Submitted Date

Apr 17, 2006

First Submission Date that Met QC Criteria

Apr 17, 2006

First Posted Date

Apr 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2007

Last Update Posted Date

Jun 14, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107Estimated

Name	Type	Description	Arm Group Labels	Other Names
Nitric oxide, Carbon monoxide, Helium	Drug

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tobias Pantalitschka, MD	Contact	+49 70712984711		tobias.pantalitschka@med.uni-tuebingen.de

Overall Officials

Name	Affiliation	Role
Tobias Pantalitschka, MD	University Hospital Tuebingen, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University children´s hospital	Recruiting	Tübingen		72076	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D009569	Nitric Oxide
D002248	Carbon Monoxide
D006371	Helium

Ancestor Terms

ID	Term
D026361	Reactive Nitrogen Species
D005609	Free Radicals
D007287	Inorganic Chemicals
D009589	Nitrogen Oxides

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
TLNOss
TLCOsb

Measure	Description	Time Frame
Breathing frequency
tidal volume
functional residual capacity