- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00163696
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease
July 25, 2007 updated by: Bayside Health
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
The researchers are investigating a novel technique, the multi breath nitrogen washout technique, to measure airway changes in various respiratory diseases.
Study Overview
Status
Unknown
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 Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3004
- Recruiting
- Alfred Hospital
-
Contact:
- Bruce Thompson
- Phone Number: ++61 3 9276 3476
- Email: b.thompson@alfred.org.au
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Doctor diagnosed cystic fibrosis, asthma
- Lung transplant recipient
Exclusion Criteria:
- Smoke history of less than 10 pack years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruce Thompson, Head of Physiology Services, Alfred Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Registration Dates
First Submitted
September 11, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
July 26, 2007
Last Update Submitted That Met QC Criteria
July 25, 2007
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Infant, Newborn, Diseases
- Bronchial Diseases
- Genetic Diseases, Inborn
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Pancreatic Diseases
- Bronchitis
- Fibrosis
- Asthma
- Cystic Fibrosis
- Bronchiolitis
- Bronchiolitis Obliterans
Other Study ID Numbers
- MBNW alfred
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.