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Spirometry is a useful clinical tool for the assessment and monitoring of lung disease, however, it does not provide information on peripheral airways resistance. On the contrary, impulse oscillometry (IOS) may provide information not only on airway resistance (Rrs) but also on the elastic properties of the lung (Xrs). In addition, multiple breath nitrogen washout (MBNW) utilizes the exhalation of nitrogen gas from the airways to determine changes in lung ventilation and derive small airways indices (that tells us about small airways calibre). This method, like IOS, allows a precise assessment of small airways function.
Even though patients with asthma may show some reduction of the caliber of the small airways these changes are more a feature of patients with COPD. The study team hypothesize that IOS and MBNW measurements may detect these differences and provide different resistance profiles for asthma and COPD. Furthermore, the study team would like to investigate the relationship between airway inflammation and small airway disease by measuring exhaled nitric oxide (NO) at multiple exhalation flow rates. This technique allows the partitioning of NO produced in the central airways from that generated more peripherally in the lung, providing valuable information on the activity of inflammation in different parts of the respiratory system. The study team hope that the combined use of IOS, MBNW and NO will identify a possible correlation between inflammation and small airway dysfunction.
Background
The main objective of this study is to measure the damage of the small airways in lung disease exploring the "silent zone" with methods that have not been used before together in the same patients. Furthermore, because this is a 4 year longitudinal study, the study team will investigate the time related changes of small airway function in lung disease and normal healthy subjects.
The study will also investigate the relationship between small airway resistance and inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 | Mild-moderate asthma. Within the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009). | ||
| 4 | Severe Asthma Within the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009). | ||
| 1 | Normal subjects Normal subjects were a group made up of healthy subjects, with normal lung function, non-smokers at the time of the screening. | ||
| 2 | Healthy smokers Healthy smokers were comprised of people who were current smokers and had normal lung function at the time of screening. | ||
| 5 | COPD (Gold stage I - III) The COPD group included stage I to III patients, classified according to severity of airflow limitation (post bronchodilator FEV1), from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD, 2011). |
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| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | Forced expiratory volume in one second | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Calv | Nitric oxide arising from the alveolar compartment. | 120 minutes |
| AX | Reactance area for whole-breath | 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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patients will be recruited from outpatient clinics
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Paredi, MD, PhD | Airway Disease Section, National Heart and Lung Institute, Imperial College, London | Study Director |
| Omar A Usmani, MD, PhD | Airway Disease Section, National Heart and Lung Institute, Imperial College, London | Principal Investigator |
| Peter J Barnes, Prof | Airway Disease Section, National Heart and Lung Institute, Imperial College, London | Study Chair |
| Neil Pride, Prof | Airway Disease Section, National Heart and Lung Institute, Imperial College, London | Study Chair |
| Michael Goldman, Prof | Airway Disease Section, National Heart and Lung Institute, Imperial College, London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Airway Disease Section, National Heart and Lung Institute, Imperial College | London | SW3 6LY | United Kingdom |
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This was a single centre cross-sectional and longitudinal study involving asthmatic and chronic obstructive pulmonary disease (COPD) patients and healthy volunteers (including smokers).
Subjects were between the ages of 18-85 years old, were given a patient information sheet and provided their written informed consent. Subjects were interviewed at visit 1 and a medical history was documented.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mild-moderate Asthma | Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009). |
| FG001 | Severe Asthma | Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009). |
| FG002 | Normal Subjects | This group consisted of 29 never-smokers with no history of respiratory disease. |
| FG003 | Healthy Smokers | Healthy smokers had no history of respiratory disease, and were all current smokers |
| FG004 | COPD (Gold Stage I - III) | COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Subjects | This group consisted of 29 never-smokers with no history of respiratory disease |
| BG001 | Healthy Smokers | The healthy smoking group consisted of 20 current smokers with no history of respiratory disease |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FEV1 | Forced expiratory volume in one second | Posted | Mean | Standard Deviation | L | 120 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild-moderate Asthma | Mild-moderate asthma recruited at baseline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Harpal Singh Kalsi | Queen Mary University of London | 07872492181 | h.kalsi@qmul.ac.uk |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D017563 | Lung Diseases, Interstitial |
| D003550 | Cystic Fibrosis |
| D007249 | Inflammation |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| R5 EX | Resistance measured at 5 hertz during expiration | 120 minutes |
| J'aw | Bronchial nitric oxide flux | 120 minutes |
| Sacin | Ventilation heterogeneity within the acinar airways | 120 minutes |
| Scond | Ventilation heterogeneity within the conducting airways | 120 minutes |
| BG002 | Mild-moderate Asthma | Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009). |
| BG003 | Severe Asthma | Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009). |
| BG004 | COPD (Gold Stage I - III) | COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011). |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoking status | Number | participants |
|
This group consisted of 29 never-smokers with no history of respiratory disease
| OG003 | Healthy Smokers | The healthy smoking group consisted of 20 current smokers with no history of respiratory disease |
| OG004 | COPD (Gold Stage I-III) | COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011). |
|
|
| Secondary | Calv | Nitric oxide arising from the alveolar compartment. | Posted | Mean | Standard Error | ppb | 120 minutes |
|
|
|
| Secondary | AX | Reactance area for whole-breath | Posted | Mean | Standard Deviation | kPa/L | 120 minutes |
|
|
|
| Secondary | R5 EX | Resistance measured at 5 hertz during expiration | Posted | Mean | Standard Deviation | kPa/L/s | 120 minutes |
|
|
|
| Secondary | J'aw | Bronchial nitric oxide flux | Posted | Mean | Standard Deviation | nl/s | 120 minutes |
|
|
|
| Secondary | Sacin | Ventilation heterogeneity within the acinar airways | Posted | Mean | Standard Deviation | /L | 120 minutes |
|
|
|
| Secondary | Scond | Ventilation heterogeneity within the conducting airways | Not all subjects have results for this parameter which is why the total number of results will not equal the number of participants recruited. | Posted | Mean | Standard Deviation | /L | 120 minutes |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sever Asthma | Sever Asthma recruited at baseline | 0 | 23 | 0 | 23 |
| EG002 | Normal Subjects | Normal subjects at baseline | 0 | 29 | 0 | 29 |
| EG003 | Healthy Smokers | Healthy smokers at baseline | 0 | 20 | 0 | 20 |
| EG004 | COPD (Gold Stage I - III) | COPD (Gold stage I - III) baseline | 0 | 34 | 0 | 34 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D012120 | Respiration Disorders |