Pulmonary Diffusing CapacityPhase 1NCT00315965
Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects
A Phase 1 study testing Nitric oxide, Carbon monoxide, Helium in people with Pulmonary Diffusing Capacity, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 6 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Diffusing Capacity
- What is being tested?
- Nitric oxide, Carbon monoxide, Helium
- How many people
- 107 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2006to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy volunteers
- Lung function testing possible
- Written consent
Who cannot join
- Pulmonary, neuromuscular, cardiovascular, endocrinological illness
- Pregnancy
- Abuse of nicotine, alcohol, drugs during the last two years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University children´s hospital
Tübingen, 72076
Tobias Pantalitschka, MD, +49 7071 2984711, tobias.pantalitschka@med.uni-tuebingen.de
Tobias Pantalitschka, MD
About this study
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.
- Conditions
- Pulmonary Diffusing Capacity
- Being tested
- Nitric oxide, Carbon monoxide, Helium
- Keywords
- Diffusion, Membrane diffusing capacity, Alveolar capillary gas diffusion, Transfer factor, Nitric oxide diffusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric oxide, Carbon monoxide, HeliumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
TLNOss
TLCOsb
Secondary outcomes (8)
Breathing frequency
tidal volume
functional residual capacity
airway resistance
lung clearance index
forced expiratory volume in one second
vital capacity
total lung capacity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startJul 2006
- Study completionSep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Diffusing CapacityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Tobias Pantalitschka, MD, Principal investigator, University Hospital Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315965
- Sponsor's protocol ID
- ESNOD-01
- Status last verified
- May 2007
- First submitted
- 17 Apr 2006
- Last updated
- 14 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00315965
- Acronym / sponsor ID
- ESNOD-01
- Conditions
- Pulmonary Diffusing Capacity
- Keywords
- Diffusion, Membrane diffusing capacity, Alveolar capillary gas diffusion, Transfer factor, Nitric oxide diffusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Sep 2007 (estimated)
- First posted
- 19 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Lung function testing possible
- Written consent
Key exclusion criteria (3 listed)
- Pulmonary, neuromuscular, cardiovascular, endocrinological illness
- Pregnancy
- Abuse of nicotine, alcohol, drugs during the last two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric oxide, Carbon monoxide, Helium | Drug | – |
Primary outcome
TLNOss
TLCOsb
8 secondary outcomes
Breathing frequency
tidal volume
functional residual capacity
airway resistance
lung clearance index
forced expiratory volume in one second
vital capacity
total lung capacity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Pantalitschka, MD principal investigator
University Hospital Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nitric oxide, Carbon monoxide, Helium in people with Pulmonary Diffusing Capacity, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Pantalitschka, MD (+49 70712984711, tobias.pantalitschka@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLNOss. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2007.