Entwicklung einer Untersuchungsmethode zur Bestimmung des NO-Transferfaktors der Lunge Evaluierung der Methode und Normwerterhebung an gesunden Probanden (Development of a new method for steady-state measurement of NO lung diffusing capacity in healthy subjects)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005678-61-DE
• Date of registration: 29/12/2005
• Prospective Registration: Yes
• Primary sponsor: University Hospital Tuebingen
• Public title: Entwicklung einer Untersuchungsmethode zur Bestimmung des NO-Transferfaktors der Lunge Evaluierung der Methode und Normwerterhebung an gesunden Probanden (Development of a new method for steady-state measurement of NO lung diffusing capacity in healthy subjects)
• Scientific title: Entwicklung einer Untersuchungsmethode zur Bestimmung des NO-Transferfaktors der Lunge Evaluierung der Methode und Normwerterhebung an gesunden Probanden (Development of a new method for steady-state measurement of NO lung diffusing capacity in healthy subjects)
• Date of first enrolment: 22/02/2006
• Target sample size: 107
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005678-61
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: the trial compares the transfer factor for nitric oxide and carbon monoxide

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
• voluntary healthy persons, age 6-45 years
• lung function testing is possible without restriction
• written informed consent


Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• pulmonary, cardiological, endocrinological or neurological illness
• Participation in another clinical trial
• pregnancy and nursing
• uncertain contraception
• abuse of nicotine, alcohol or drugs in the last 2 years




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Lung function testing (NO- and CO Transferfactor) in healthy subjects

Intervention(s)

Product Name: Nitric Oxide in Nitrogen
Product Code: NO
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Nitric Oxide
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.1-
INN or Proposed INN: Nitrogen
Concentration unit: % percent
Concentration type: equal
Concentration number: 99.9%-

Product Name: Helium-Oxygen
Product Code: He
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Helium
Concentration unit: % percent
Concentration type: equal
Concentration number: 79-
INN or Proposed INN: Oxygen
Concentration unit: % percent
Concentration type: equal
Concentration number: 21-

Product Name: Carbon Monoxide-Helium-Artificial Air
Product Code: CO
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Carbon Monoxide 3.0
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.262-
INN or Proposed INN: Helium 4.6
Concentration unit: % percent
Concentration type: equal
Concentration number: 9.49-
INN or Proposed INN: Artificial Air
Concentration unit: % percent
Concentration type: equal
Concentration number: 90.248-

Primary Outcome(s)

Main Objective: Main objective of the clinical trial is the evaluation of a new method (nitric oxide multiple breath) for measuring lung diffusion capacity in comparison to a standard method (single-breath carbon monoxide) as well as the survey of normative values in voluntary healthy persons.

Secondary Objective:

Primary end point(s): transfer factor for nitric oxide and carbon monoxide

Secondary ID(s)

not available

ESNOD-01