Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104-week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE*) 50/500mcg Delivered Twice Daily Via the DISKUS*/ACCUHALER* Inhaler With Tiotropium Bromide 18 mcg Delivered Once Daily Via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.


Options:
A: Inclusion Criteria:

* Current or ex-smokers
* aged over 50years
* FEV1/FVC ratio less than 0.7
* FEV1 less than 60% predicted

Exclusion Criteria:

* Diagnosis of asthma, ABPA or bronchiectasis
* Recent RTI or steroid use
* Inability to perform study procedures or to give informed consent
* Known sensitivity to trial medications
B: Inclusion criteria:

* Patients with COPD and FEV1 \<60% of predicted normal and baseline (pre-bronchodilator) FEV1/FVC ratio \<70%.
* Current or ex-smokers with a smoking history of at least 10 pack-years.

Exclusion criteria:

* Diagnosis of other respiratory disorders (including asthma).
* Requirement for long term oxygen therapy.
C: Inclusion criteria:

* Established clinical history of moderate to severe COPD.
* Post bronchodilator FEV1 of \< 50% of predicted normal.
* FEV1 / FVC ratio \<70%.
* Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1.
* Free from exacerbation in the 6 weeks prior to screening.
* Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations.

Exclusion criteria:

* Current asthma, eczema, atopic dermatitis and/or allergic rhinitis.
* Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis).
* Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study.
* Has undergone lung transplantation and/or lung volume reduction.
* Female who is a nursing mother.
* Requires regular (daily) long-term oxygen therapy (LTOT).
* Is receiving beta-blockers (except eye drops).
* Has a serious, uncontrolled disease likely to interfere with the study.
* Has received any other investigational drugs within the 4 weeks prior to Visit 1.
* Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
* Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids, anticholinergic agents or any components of the formulations (e.g. lactose or milk protein).
D: Inclusion Criteria:

* Written informed consent.
* Male or female patients 40 years of age or older.
* Smoking history of at least 10 pack years.
* Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1\<70% of FVC and on stable respiratory medication.

Exclusion Criteria:

* Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
* Myocardial infarction in past 6 months.
* Unstable or life threatening arrhythmia in past year.
* Hospitalization for NYHA heart failure class III or IV in past year.
* Active tuberculosis.
* Asthma.
* Pulmonary resection.
* Malignancy treated with radiation or chemotherapy in past 5 years.
* Respiratory infection in 4 weeks prior to screening.
* Known hypersensitivity to anticholinergic drugs or components.
* Known moderate to severe renal impairment.
* Known narrow angle glaucoma.
* Significant symptomatic BPH or bladder neck obstruction.
* Need for oxygen therapy \>12 hr/day.
* Use of oral corticosteroids at unstable doses or \>10 mg/day.

Answer: C