Please select the eligibility criteria that correspond to the clinical trial below.
Title: Adherence to Therapy in COPD Patients Under Dose Escalation of Roflumilast
Brief Summary: Main adverse events of Roflumilast are weight loss, loss of appetite, insomnia, headache, diarrhea, vomiting, and nausea. Although the majority of these adverse reactions were mild or moderate. They occurred mainly at the beginning of therapy and mostly resolved with continued treatment around for two weeks according to experiences of clinicians. These adverse events occur more often in Roflumilast 500 μg than 250 μg, having negative impact on compliance of patients at the early stage of treatments.

Thus, investigators aim to compare the drop-out rates between the usual dosage (Roflumilast 500 μg once daily) and the dose escalation (Roflumilast 250 μg once daily for 4 weeks and then escalating dose of 500 μg once daily).


Options:
A: Inclusion Criteria:

* Community dwelling patients eligible for NMS (aged from 14 years starting a new medicine for asthma/COPD, diabetes (Type 2), antiplatelet/anticoagulation or hypertension).

Exclusion Criteria:

* Patients collecting a repeat prescription for a medicine (i.e. not new) for asthma/COPD, type 2 diabetes mellitus (T2DM), antiplatelets/anticoagulants or hypertension
* Patients collecting a medicine where the only change from the previous medicine involves a dosage or formulation change only
* Participants who are unable to understand patient/participant study documents
* Participants who are unable and unwilling to provide written consent / assent
B: Inclusion Criteria:

1. Be 18 years or older
2. Be able to provide informed consent
3. Be admitted to the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center
4. Have a smartphone or tablet compatible with activity tracking devices
5. Plan to be discharged to home

Exclusion Criteria:

Have no medical condition which prohibits them from ambulating or plan for any medical procedure over the next 6 months that would prohibit them from ambulating.
C: Inclusion Criteria:

1. Male or female older than 40 years
2. Clinical diagnosis of COPD (confirmed with a post-bronchodilator forced expiratory volume in 1 s \[FEV1\]/forced vital capacity \[FVC\] ratio ≤70%) at least 4 weeks prior to the study and post-bronchodilator FEV1 is 50% or less than the predicted value
3. Former smokers or current smokers with at least a 10 pack-year history
4. A history of exacerbation (scheduled/unscheduled visits to primary care physicians, specialists or allied healthcare professionals, or emergency room, or hospitalization due to purulent sputum or increased sputum, or increased dyspnea) in the previous year (at least one)
5. Chronic bronchitis (cough and sputum production for at least three months within two years)
6. Able to have the signed written informed consent prior to any study-related procedures.

Exclusion Criteria:

1. COPD exacerbation or respiratory infection 4 weeks prior to the baseline visit
2. Known a1-antitrypsin deficiency
3. Need for long-term oxygen therapy
4. Moderate to severe liver impairment (Child-Pugh B or C)
5. Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, etc)
6. Severe acute infectious diseases
7. Cancers
8. Subjects being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term) except short-term systemic corticosteroids)
9. Latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster
10. Subjects with congestive heart failure (NYHA grades 3 and 4)
11. Subjects with a history of depression associated with suicidal ideation or behavior
12. Clinically meaningful bronchiectasis
13. Pregnancy or breast feeding, or Female subjects of childbearing potential unwilling to use effective contraception
14. Patients with known hypersensitivity to Roflumilast or rescue medication and their ingredients
15. Patients with previous Roflumilast therapy within past 3 months
D: Inclusion Criteria:

Inclusion criteria on cluster level are:

1. Written agreement to participate in the study;
2. Agreement that a care pathway for COPD will not be developed and used within the time frame of the study when randomized in the control group.

Inclusion criteria on patient level are:

1. Written informed consent;
2. All consecutive admissions with COPD exacerbation;
3. Hospitalization for at least 48 hours;
4. Moderate, severe or very severe COPD;
5. Each patient will be included only once in the study at initial hospitalization, even if the patient had been hospitalized more than once.

Exclusion Criteria:

Exclusion criteria on patient level:

1. Admission required to intensive care unit;
2. Need for Invasive Positive Pressure Ventilation (IPVV).

Inclusion criteria on multidisciplinary team level:

1. Team members are involved in direct patient care responsibilities for COPD;
2. Minimum representation of the core disciplines according to COPD literature;

Answer: C