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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The proposed study will evaluate (for newly diagnosed Chronic Obstructive Pulmonary Disease (COPD) patients)the time taken to prescription of triple therapy by aiming to answer these following research questions:
Triple therapy consists of long-acting beta agonist (LABA) + inhaled corticosteroids (ICS) + long-acting muscarinic antagonist (LAMA) and typically should be reserved for patients who have severe to very severe (FEV1 <50%) COPD symptoms or for patients who have two or more exacerbations per year. However previous research from RiRL indicate that 50% of patients at GOLD stage II (moderate) receive ICS of which half were on triple therapy.
To allow for multiple analysis regarding the factors that influence the likelihood of being prescribed triple therapy, a bespoke COPD dataset will be created to include:
This retrospective, observational study using data of COPD patients will assess treatment pathways (changes/step up) from initial date of COPD diagnosis with the prescription of triple therapy as the endpoint.
Specific questions that will be asked are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prior Triple Therapy | Patients prescribed triple therapy prior to initial date of COPD diagnosis | ||
| Triple therapy at COPD diagnosis | Patients prescribed triple therapy on date of initial COPD diagnosis | ||
| Triple therapy after COPD diagnosis | Patients prescribed triple therapy after initial date of COPD diagnosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Triple Therapy Status | The proportion of patients prescribed triple therapy and whether they were prescribed it prior to, at, or after initial date of COPD diagnosis. | 1 year |
| Initial date of COPD diagnosis | The date that patients were initially diagnosed with COPD. Categorised into cohorts- 1997-2001, 2002-2006, 2007-2010. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function grade | Patient lung function grade, calculated by GOLD I, II, III, IV criteria. | 1 year |
| Asthma Diagnosis | Proportion of patients with a co-morbid asthma diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will have a QoF approved COPD read code and must be aged ≥ 40.
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| Name | Affiliation | Role |
|---|---|---|
| David Price, Prof, MD | University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research in Real Life Ltf | Cambridge | CB24 3BA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23135217 | Background | Price D, Yawn B, Brusselle G, Rossi A. Risk-to-benefit ratio of inhaled corticosteroids in patients with COPD. Prim Care Respir J. 2013 Mar;22(1):92-100. doi: 10.4104/pcrj.2012.00092. | |
| 19688142 | Background | Price D, Crockett A, Arne M, Garbe B, Jones RC, Kaplan A, Langhammer A, Williams S, Yawn BP. Spirometry in primary care case-identification, diagnosis and management of COPD. Prim Care Respir J. 2009 Sep;18(3):216-23. doi: 10.4104/pcrj.2009.00055. |
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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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| 1 year |
| COPD patient group | Patients COPD patient group, calculated by GOLD A, B, C, D criteria dependent on symptoms and risk of patient. | 1 year |
| COPD exacerbations (Clinical experience based) | Number of the following: (i) Asthma/copd-related*: a. Hospital attendance / admissions OR b. A&E attendance OR (ii) GP consultations for lower respiratory related tract infections | 1 year |
| Smoking Status | Patient smoking status, taken from routine and questionnaire data | 1 year |
| BMI | Patient BMI class | 1 year |
| COPD co-morbidities | COPD co-morbidities are identified via Read codes that are recorded at any time. Co-morbidities are: GERD, Rhinitis, Heart Failure, Ischaemic Heart Disease, Diabetes, Osteoporosis, Chronic Renal Failure, Chronic Kidney Disease and Anxiety-Depression | 1 year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |