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Goal 2: Reduce Human Disease

Outcomes of heterogeneous responses to tiotropium

Tiotropium is widely used for COPD, but patients report highly variable responses to this medication. A clinical trial of severe COPD subjects could address both short-term (bronchodilator effect) and intermediate-term (COPD exacerbations) outcomes of this heterogeneous response by examining radiologic (chest CT), clinical (Six Minute Walk, Spirometry), and pharmacogenetic (GWAS) influences on this heterogeneous response. ...more »

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Goal 2: Reduce Human Disease

Clinical trials of AAT augmentation therapy

Alpha-1 antitrypsin augmentation therapy is widely used for PI ZZ subjects, but randomized clinical trials of AAT augmentation therapy have not been adequately powered to assess the efficacy of this treatment. A clinical trial using COPD exacerbation frequency as the primary outcome, rather than decline in lung function, in PI ZZ subjects with moderate-to-severe COPD could provide definitive evidence for the utility of ...more »

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Goal 2: Reduce Human Disease

Clinical trial of AAT augmentation therapy in PI MZ subjects

Although severely alpha-1 antitrypsin deficiency (PI ZZ) individuals are rare, PI MZ subjects comprise approximately 3% of the US population. Mounting evidence suggests that PI MZ is a significant risk factor for COPD. A clinical trial of COPD exacerbation frequency using AAT augmentation therapy in PI MZ subjects with moderate-to-severe COPD could provide a rationale for AAT augmentation therapy (or small molecule neutrophil ...more »

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Goal 3: Advance Translational Research

Including subjects with both COPD and asthma in clinical trials

Subjects with both COPD and asthma are typically excluded from clinical trials, but they represent an important segment of the chronic airflow obstruction population. Defining this combination diagnosis is difficult, but requiring a significant smoking history (e.g. 10 pack years), chronic airflow obstruction (GOLD stage 2 or greater after bronchodilator), age > 45, and childhood onset of asthma could identify the relevant ...more »

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Goal 2: Reduce Human Disease

Spirometry for diagnosis and treatment of COPD

1. What is the comparative effectiveness of different approaches to implementing use of spirometry in primary care to confirm the diagnosis of COPD (e.g., increased reimbursements, use of EMRs and other tools) 2. What is the comparative effectiveness of using symptoms vs. spirometry in increasing patient and adherence to COPD treatment guidelines? 3. What is the comparative effectiveness of using a fixed FEV1/FVC ratio ...more »

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Management of COPD in the presence of comorbidity

Management of COPD in the presence of comorbidity • Does a protocol-based screening for commonly occurring comorbid conditions in patients with COPD (eg. CAD, CHF, depression, sleep apnea) improve management and outcomes for patients with COPD? • How should providers coordinate management strategies and treatment goals in patients with COPD and other co-existing chronic diseases? • What is the comparative effectiveness ...more »

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Goal 3: Advance Translational Research

Implementation of checklist to improve outcomes of COPD patients with acute exacerbations

Implementation of checklist to improve outcomes of COPD patients with acute exacerbations

 

• Does implementation of a checklist designed to improve the care of patients with COPD exacerbations result in greater adherence to guideline recommendations?

 

• Does implementation of a checklist designed to improve the care of patients with  COPD exacerbations results in improved patient outcomes?

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Integrated healthcare strategies during transitions in COPD care

Integrated healthcare strategies during transitions in COPD care

 

• What is cost effectiveness of multi-component COPD programs?

 

• Will early admission to a Pulmonary Rehabilitation program following a hospitalization for COPD reduce the likelihood of readmission within the following year?

 

• What is the most effective time to implement the transition from hospitalization following a COPD exacerbation admission?

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Challenges for future clinical trials in COPD

There are two broad issues that any future clinical trials in COPD need to seriously consider, that of the challenges of timely and efficient subject recruitment and the need to increase the participation of low to middle income countries that experience a disproportionate burden of COPD in evidence generation. My specific suggestions are as follows: 1) Address the optimal medical management of multiple physical and psychological ...more »

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Goal 2: Reduce Human Disease

COPD hospitalizations

COPD hospitalizations a. Define the pathobiological changes that lead to severe exacerbations that cause hospitalizations b. Define novel clinical and biological phenotypic characterizations of hospitalized patients who fail treatment that results in death or early readmission c. Explore new or understudied therapies for treatment of acute COPD hospitalizations: antioxidant, non-steroidal anti-inflammatory (STATIN or ...more »

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