Skip to content

Early detection of lung disease in smokers with normal spirometry

Multiple breath nitrogen washout (MBNW) and impulse oscillometry system (IOS) to detect small airway disease in smokers with normal spirometry

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000079549
Enrollment
100
Registered
2015-01-30
Start date
2012-05-21
Completion date
2013-09-20
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In chronic obstructive pulmonary disease (COPD), commonly associated with long term smoking, the earliest abnormality occurs in the very small airways. However, these changes to the small airways are unable to be detected by common lung function tests used in clinical practice and therefore early detection of COPD at present is impossible. In our laboratory we have two easy-to-perform lung function tests that are sensitive to abnormalities in the small airways and we want to determine whether these tests are able to detect abnormalities when common lung function tests remain normal and if they can be treated with administration of bronchodilators. If either of these tests are sensitive to small airway abnormalities it will mean that they have the potential to be used for the early detection of COPD in smokers. We hypothesise that IOS parameters will be sensitive to alterations in small airway function, as defined by abnormal ventilation heterogeneity measured by MBNW, in smokers with normal spirometry. Also, these abnormalities may be partially of completely reversed with bronchodilators.

Interventions

There will be one (1) visit for this study which will either take place at the Woolcock Institute of Medical Research or at the Respiratory Investigation Unit at Royal North Shore Hospital. The visit will last around 90 minutes. All tests that we will administer are used routinely for lung function testing in hospital lung function laboratories in Australia and internationally. We will perform an allergy test called a skin prick test. A small droplet of allergen will be placed on subject's for

There will be one (1) visit for this study which will either take place at the Woolcock Institute of Medical Research or at the Respiratory Investigation Unit at Royal North Shore Hospital. The visit will last around 90 minutes. All tests that we will administer are used routinely for lung function testing in hospital lung function laboratories in Australia and internationally. We will perform an allergy test called a skin prick test. A small droplet of allergen will be placed on subject's forearm and the skin will be pricked lightly through the droplet. If subject is allergic to any of the allergens you will develop a small itchy lump, like a mosquito bite. Subject's lung size will be measured in a body plethysmograph. This requires sitting in a clear Perspex booth during which subject will be asked to breathe on a mouth piece.Subject will be asked to breathe at different speeds and to take in a slow deep breath and then breathe out slowly and push all the air out of your lungs. The whole test will take approximately 15 minutes. Two types of simple breathing tests will be conducted to measure how efficient subject's lungs are at moving air in and out. For the first test, known as spirometry, subject will be asked to take a deep breath and blow as hard and fast as you can for as long as you can into the mouthpiece. This manoeuvre will be repeated three times, and will take five minutes. For the second test, subject will be asked to breathe quietly on a mouthpiece for one minute while wearing a nose clip. Subject will feel a slight “flutter” in the air that he will breathe during this test, but it will not cause any discomfort. A washout test will tell us how evenly air is distributed throughout the lungs. Subject will breathe into a mouthpiece, keeping the size of your breaths within a set range. During the test you will first breathe normal room air and then 100% oxygen for approximately 20 breaths. Each test is performed 3 times and it takes about 20-25 minutes to complete all three tests. All the measurements will be made before and 20 minutes after inhalation of 200microgram of salbutamol (2 puffs) and 80 microgram of ipratropium bromide (4 puffs) via metered dose inhaler and large volume spacer in smokers with normal spirometry.

Sponsors

Kanika Jetmalani
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Smokers with greater than equal to 10 Pack years of smoking history and Normal spirometry defined as FEV1> 80% predicted and FEV1/FVC greater than 0.70 Non smokers with Normal spirometry defined as FEV1> 80% predicted and FEV1/FVC greater than 0.70

Exclusion criteria

Any history of respiratory disease or cardiovascular disease. Women who are pregnant People who are unable to understand the patient information statement Same criteria for never smokers will be included

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026