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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
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This is a clinical study to characterise the lung function, airway morphometry, pharyngometry and inhalation profiles in patients with mild to severe Idiopathic Pulmonary Fibrosis (IPF) over a period of up to 6 months. Inhalation profiles will be recorded from patients with IPF as they inhale during tidal breathing, and following two sets of instructions (maximal effort and 'long, steady and deep' inhalation), across a range of airflow resistances that reflect those of typical inhalers used to deliver medication to the lungs. Mouth and throat dimensions will be measured using an acoustic reflectance Pharyngometer. Measurements of lung function will be made using conventional sprirometry, plethysmography and diffusion, whilst Low Dose High Resolution Computed Tomography (HRCT) will be used to scan the airways at two lung volumes; functional residual capacity (FRC) and total lung capacity (TLC). Data from HRCT will be used to reconstruct airway morphometry, and model inhaled particle deposition within the lung. Overall, the study allows a further understanding of the IPF patient population, using the data to assist in the development of new inhaled products for this disease. Following up the patients with additional HRCT scans at 3 and 6 months will enable the sensitivity of CT based criteria of disease progression to be compared with lung function criteria. No investigational product will be used in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | This is a clinical study to characterise the lung function, airway morphometry, pharyngometry and inhalation profiles in patients with mild to severe Idiopathic Pulmonary Fibrosis (IPF) over a period of up to 6 months. Approximately 30 subjects will be enrolled so that at least 20 subjects complete all critical assessments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months | Other | Patients are receiving no treatment on this study and there is no investigational product involved. |
| Measure | Description | Time Frame |
|---|---|---|
| To characterise the inhalation profiles | Inhalation profile was characterised by assessing Peak pressure Drop (kPa), Peak Inspiratory Flow Rate (L/min), Inhaled Volume (L), Inhalation time (s), Average Inhalation Flow Rate (L/min), Acceleration rate (L/min/s) | Up to 6 months |
| To characterise the pharyngometry | The pharyngometry characters were assessed by Distance (cm), Volume (cm^3), Average cross sectional area (cm^2). | Up to 6 months |
| Mouth and throat measurements from HRCT scan reconstruction | Mouth and throat measurements from HRCT scan reconstruction assessing Length (mm), Minimum cross-sectional area square millimetre(mm^2), Average cross-sectional area (mm^2), Concavity, Volume (mm^3) | Up to 6 months |
| Lung measurements from HRCT scan | Lung measurements from HRCT scan by assessing Volume, length, direction and diameter of each airway branch at FRC and TLC, Lobar volumes at FRC and TLC, Relative lobar growth from FRC to TLC, Total lung volume at FRC and TLC | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the relationship between changes in airway morphometry determined by HRCT and measures of spirometry, diffusion and plethysmography | Lung function by spirometry (FVC, FEV1, Vmax25 and 50, PEFR and PIFR) | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Edegem | 2650 | Belgium |
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| Label | URL |
|---|---|
| Results for study 117275 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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