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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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This is an international, mulitcentre, observational, prospective study into Peak Inspiratory Flow in COPD patients that aims to: A) Determine the prevalence of suboptimal Peak Inspiratory Flow (PIF) and inadequate inhaler choice and assess the baseline characteristics of these groups. B) Assess the clinical role of PIF and inhaler choice in predicting COPD exacerbations and symptom burden. C) Assess the variability and correlation of PIF with other lung function measurements and CAT score in stable COPD. It is a 12 month study comprising one baseline assessment and 2 follow-up visits at 6 and 12 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Non-interventional, subjects will only have routine testing (blood biomarkers, spirometry, peak inspiratory flow measurements) and be asked to complete questionnaires. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of suboptimal PIF and inadequate inhaler choice. | Determine the prevalence of suboptimal PIF and inadequate inhaler choice. | Baseline |
| Exacerbations | Time to first exacerbation associated with different levels of PIF. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PIF and symptom burden | PIF measurements will be correlated with COPD Assessment Test (CAT) Scores. CAT scores range from 0-40 depending on the severity of a persons symptoms; higher scores denote a more severe impact of COPD on a patient's life. | Baseline, 6 and 12 months |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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COPD patients, who are clinically stable (4 exacerbations in previous 4 weeks) and have been taking inhaled medications for at least 6 months, but have no other chronic respiratory conditions, other than asthma or bronchiectasis.
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| Name | Affiliation | Role |
|---|---|---|
| Omar Usmani, MD | National Heart and Lung Institute, Imperial College London & Royal Brompton Hosp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Sassari | Sassari | Italy | ||||
| Mater Dei Hospital |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Annual mortality rate associated with different PIF levels. |
| 6 and 12 months |
| Variability and correlation of PIF | Variability of PIF over time and the correlation between PIF and other lung function measures (including FEV1, FVC, Inspiratory capacity), CAT scores, T2 markers (nasal polyps and dermatitis) and where available blood biomarkers. | Baseline, 6 and 12 months |
| Exacerbation rate | Annual rate of exacerbations associated with different PIF levels | 6 and 12 months |
| Valletta |
| Malta |
| Changi General Hospital | Singapore | Singapore |
| Singapore General Hospital | Singapore | Singapore |
| Ljubljana University Medical Centre | Ljubljana | Slovenia |
| Hanyang University Guri Hospital | Hanyang | South Korea |
| Seoul St. Mary's Hospital | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| Hospital University de Torrecárdenas | AlmerĂa | Spain |
| University Hospital Vall d'Hebron | Barcelona | Spain |
| Hospital Inmaculada HLA | Granada | Spain |
| HU Virgen de las Nieves | Granada | Spain |
| Hospital Universitario de La Ribera | Valencia | Spain |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |