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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00163696
Other study ID # MBNW alfred
Secondary ID
Status Recruiting
Phase N/A
First received September 11, 2005
Last updated July 25, 2007
Start date September 2004

Study information

Verified date September 2005
Source Bayside Health
Contact Bruce Thompson
Phone ++61 3 9276 3476
Email b.thompson@alfred.org.au
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Observational

Clinical Trial Summary

The researchers are investigating a novel technique, the multi breath nitrogen washout technique, to measure airway changes in various respiratory diseases.


Description:

It is well documented that there are significant ventilatory changes in respiratory diseases such as cystic fibrosis, asthma and the onset of bronchiolitis obliterans syndrome (BOS) following chronic rejection of lung transplantation. At present, we use measures such as spirometry and lung biopsies to determine the changes of airway function and disease severity. Our aim is to develop a novel technique called the multi breath nitrogen washout (MBNW) which we believe is able to measure the inhomogeneity of ventilation in both the larger airways (conductive region, generation 1 - 16) as well as the smaller airways (acinar region 17 - 23). Our belief is that these measurements are much more subtle than current techniques and will be more sensitive in measuring large and small airway changes in disease. The MBNW can also give us an insight as to which particular zones of the lung are affected in differing respiratory disease. For example, it is believed that BOS begins at the distal portion of the lung (acinar region) and proceeds towards the proximal zone (conductive). However, at present no current techniques can differentiate between damage to the acinar zone and the conductive zone or indeed accurately measure small airway (acinar zone) function. We believe the the MBNW has the capacity to do so.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Doctor diagnosed cystic fibrosis, asthma

- Lung transplant recipient

Exclusion Criteria:

- Smoke history of less than 10 pack years

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional


Locations

Country Name City State
Australia Alfred Hospital Melbourne Victoria

Sponsors (2)

Lead Sponsor Collaborator
Bayside Health The Alfred

Country where clinical trial is conducted

Australia, 

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