Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 11, 2005

Last Updated Date

July 25, 2007

Start Date ^†

September 2004

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00163696 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease

Official Title ^†

Measurements of Inhomogeneity of the Small Airway With Patients With Cystic Fibrosis, Asthma and Bronchiolitis Obliterans Syndrome (Post Transplant) Using the Multi Breath Nitrogen Washout Technique

Brief Summary

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

Detailed 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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Natural History, Cross-Sectional, Defined Population, Prospective Study

Condition ^†

Cystic Fibrosis
Asthma
Bronchiolitis Obliterans
Lung Transplantation

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Doctor diagnosed cystic fibrosis, asthma
Lung transplant recipient

Exclusion Criteria:

Smoke history of less than 10 pack years

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Bruce Thompson

++61 3 9276 3476

b.thompson@alfred.org.au

Location Countries ^†

Australia

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00163696

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Bayside Health

Collaborators ^††

The Alfred

Investigators ^†

Principal Investigator:

Bruce Thompson

Head of Physiology Services, Alfred Hospital

Information Provided By

Bayside Health

Verification Date

September 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.