Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily
Brief Summary: The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.


Options:
A: Inclusion Criteria:

* Patients aged 30 years or older
* Current or previous cigarette smoker with a history of cigarette smoking of ≥ 10 pack-years: number of pack years = (number of cigarettes per day/20) × number of years smoked) (e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years). Previous smokers are defined as those who stopped smoking at least 3 months prior to the study visit.
* Willing and able to provide written informed consent prior to study participation (on day of study visit).
* Able to read, write, and comprehend information in English.

Exclusion Criteria:

* Prior to enrollment, prospective subjects will be screened. A subject will be excluded from the study if he/she meets any of the following criteria:
* Regular use (i.e., prescribed for use on a daily basis) of the following respiratory medications within the 4 weeks prior to the study visit:

  * Ipratropium (Atrovent, ipratropium bromide)
  * Ipratropium/albuterol combinations (e.g., Combivent)
  * Tiotropium (Spiriva, tiotropium bromide)
  * Salmeterol (SEREVENT™)
  * Formoterol (Foradil)
  * Inhaled corticosteroids (e.g., FLOVENT™, BECLOVENT™, Azmacort Aerobid, Pulmicort, QVAR, Vanceril)
  * Inhaled corticosteroid/long-acting beta-agonist combinations (e.g., ADVAIR DISKUS™ , Symbicort)
  * Theophyllines (e.g., Theo-dur, Slo-Bid, Uniphyl)
  * Oral beta-agonists (e.g.,Volmax)
* Previous lung surgery, including lung transplant, lung resection, lung volume reduction surgery (e.g., lobectomy, pneumonectomy).
* A known diagnosis of a significant lung condition including lung cancer, cystic fibrosis, pulmonary fibrosis, active tuberculosis, or sarcoidosis. A previous diagnosis of an obstructive lung disease is not exclusionary-asthma, chronic bronchitis, emphysema, alpha1-antitrypsin (A1AT) deficiency, etc.
* Current participation in a respiratory-related research study and receiving experimental medications.
* Limited ability to provide a valid informed consent due to serious uncontrolled psychiatric disease, intellectual or cognitive deficiency, poor motivation, current substance abuse (including drugs and alcohol), or other relevant condition that, in the opinion of the site principal investigator, will interfere with the subject's participation in the study.
* Pregnant females.
* Any medical or physical condition such as acute respiratory infection that would interfere with the adequate performance of spirometry.
* Participating investigator, sub-investigator, study coordinator, employee of the participating investigator, or family member of the aforementioned site staffs.
B: Inclusion Criteria:

* Has an established clinical history of COPD as defined as per the GOLD definition.
* Post-bronchodilator FEV1 of \>30% to 75% of predicted normal at Visit 1, a post-bronchodilator FEV1 / FVC ratio = 70%.
* Current or ex-smoker with a smoking history of \> 10 pack-years.

Exclusion Criteria:

* Has unstable COPD (Chronic Obstructive Pulmonary Disease).
* Has a current medical diagnosis of asthma and/or allergic rhinitis or know respiratory disorders (lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as \> 12 hours oxygen use per day).
C: Inclusion Criteria:

* \>=40 years of age, diagnosed COPD with symptoms \>=2 years, pre-bronchodilatory FEV1 \<=50% of PN

Exclusion Criteria:

* Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
D: Inclusion Criteria:

* COPD diagnosis
* At least 10 pack year smoking history
* Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal
* An FEV1/FVC ratio of less than or equal to 0.70

Exclusion Criteria:

* Current diagnosis of asthma
* Other respiratory disorder other than COPD
* Abnormal and clinical significant ECG
* Chest x-ray clinically significant abnormality not believed to be due to COPD
* Body Mass Index of greater than or equal to 40/kg/m2
* Use of Long Term Oxygen Therapy
* Lung resection surgery
* Women pregnant or lactating at Visit 1
* Previously diagnosed cancer unless in complete remission for 2 years at Visit 1

Answer: C