Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.


Options:
A: Inclusion Criteria:

* Adult male or non-pregnant, non-lactating female aged ≥40 years. Women of childbearing potential will follow specific study requirements (negative serum pregnancy test at the Screening Visit and are using, over the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control
* Current or ex-cigarette smoker (patients who quit smoking more than 6 months prior to the Screening Visit), with a smoking history of at least 10 pack-years.
* Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) according to GOLD guidelines 2013, with a post bronchodilator FEV1 \<80%, and FEV1 ≥ 40% at Screening Visit
* Patients must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society \[ATS\]/European Respiratory Society \[ERS\] 2005 criteria at Screening Visit
* Patients who are eligible and able to participate in the study and who consents to do so in writing after the purpose and nature of the investigation have been explained

Exclusion Criteria:

* History or current diagnosis of asthma
* Patients with moderate to severe sleep apnoea assessed at screening
* Patients who develop a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit (Visit 1) or during the run-in period
* Clinically significant respiratory conditions
* Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
* Patients who may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to the Screening Visit
* Use of long-term oxygen therapy (15 hours/day)
* Patients who does not maintain regular day/night, waking/sleeping cycles including night shift workers
* Clinically significant cardiovascular conditions
* QTc \>470 milliseconds in the manual ECG reading performed at Screening Visit
* Patients with clinically relevant abnormalities in the opinion of the investigator at the Screening Visit (Visit 1) in the results of the clinical laboratory tests, ECG parameters or in the physical examination)
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics, long and short acting β2-agonists, sympathomimetic amines, or inhaled medication or any component there of (including report of paradoxical bronchospasm)
* Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
* Patients with known non-controlled history of human immunodeficiency virus (HIV) infection and/or active hepatitis
* History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer
* Patients with any other serious or uncontrolled physical or mental dysfunction, or moderate-to-severe depression, as confirmed by Beck Depression Inventory (BDI-II) total score \>28.
* Patients with a history (within 2 years prior to the Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
* Patients unlikely to be cooperative or that can't comply with the study procedures.
* Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to the Screening Visit
* Patients who intends to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication
* Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study
B: Inclusion Criteria:

* age \> 45 years
* COPD diagnosed by pulmonary function tests during clinical stability, with a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ≤ 0.70
* clinical stability, defined as at least 4 weeks without antibiotics or oral corticosteroids.

Exclusion Criteria:

* living \>6 months/year outside of the included municipalities,
* living to a distance higher than 500 meters to any of the urban trails used for the study,
* mental disability according to the Mini Mental State Examination in its validated Spanish version
* comorbidity that could interfere with study tests (e.g., lower limb amputation)
* severe psychiatric disease or severe comorbidity limiting survival at one year, according to medical history.
C: Inclusion Criteria:

* Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
* Post-salbutamol Forced Expiratory Volume in one second(FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) \< 70%.
* Current or ex-smokers of ≥ 10 pack-years
* Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Exclusion Criteria:

* History or current diagnosis of asthma
* Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
* Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
* Patients with an oxygen saturation \< 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
* Contra-indications of cardiopulmonary exercise testing.
* Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.
D: Inclusion Criteria:

* Adult \>= 40 years old
* Diagnosis of COPD, emphysema or chronic bronchitis
* Able to walk a minimum of one block
* Sedentary, defined by less than 150 minutes of self-reported physical activity per week
* Have a doctor or primary care provider in the VA who can provide medical clearance
* Competent to give informed consent
* Must be a regular email user (check weekly)
* Have access to a computer with an internet connection, a USB port, and Windows XP or Vista

Exclusion Criteria:

* Diagnosis codes of quadriplegia and paraplegia or pregnancy-related diagnoses or procedures within the previous year will be excluded from potential participant pool

Answer: C