Please select the eligibility criteria that correspond to the clinical trial below.
Title: Does Chronic Ventilatory Support Improve the Outcomes of Rehabilitation in Hypercapnic COPD Patients?
Brief Summary: The purpose of this study is to investigate whether noninvasive ventilation by nose mask during the night has additional benefits next to pulmonary rehabilitation in patients with severe hypercapnic COPD.


Options:
A: Inclusion Criteria:

* COPD (FEV1\< 50%, Tiffeneau \< 70%)
* Dyspnoea on exertion and a reduced exercise capacity
* Age 75 years or less
* PaCO2 \> 6.0 kPa at rest without oxygen

Exclusion Criteria:

* Cardial/neuromuscular diseases limiting a successful rehabilitation
* Obstructive sleep apnoea syndrome: apnea/hypopnea index (AHI) \> 10
* Previous exposure to chronic NIPPV
* Participation in a pulmonary rehabilitation program less than 18 months ago
B: Inclusion Criteria:

1. Males and non-pregnant, non-lactating females aged ≥ 40.
2. Patients with a clinical diagnosis of COPD according to GOLD guidelines 2014, with a post bronchodilator FEV1 ≥ 40% and \< 80% of the predicted value and FEV1/FVC \< 70% at Visit 1.
3. Functional residual capacity (FRC) measured by body plethysmography at Visit 1 ≥ 120% of predicted value.
4. Patients with modified Medical Research Council dyspnea scale (mMRC) ≥ 2 at Visit 1.
5. Current or former cigarette smokers with a smoking history of at least 10 pack-years at Visit 1
6. Patients willing to participate in the telecoaching program during the four last weeks and to enhance their physical activity
7. Patients who understand and are able to follow the study procedures, are cooperative and are willing to participate in the study as indicated by signing the informed consent.

Exclusion Criteria:

1. History or current diagnosis of asthma.
2. Any respiratory tract infection (including upper respiratory tract) or COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period.
3. Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Visit 1 or during the run-in period.
4. Clinically significant respiratory conditions other than COPD.
5. Use of long-term oxygen therapy (≥ 15 hours/day).
6. Oxygen saturation ≤ 85% as measured by pulse oximetry during exercise testing at Visit 1, Visit 2 or Visit 3 prior to randomisation.
7. Patients with a Body Mass Index (BMI) ≥ 40kg/m2.
8. Patient who may need to start a pulmonary rehabilitation program during the study and/or who started/finished it within 3 months prior to Visit 1 or during the run-in period.
9. Patients with clinically significant cardiovascular conditions.
10. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
11. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
12. Patients with clinically relevant abnormalities in the results of the blood pressure, ECG, or physical examination at Visit 1.
13. Patients with any serious or uncontrolled physical or mental dysfunction that could place the patient at higher risk derived from his/her participation in the study or could confound the results
14. Patients with conditions other than COPD that may contribute to dyspnoea and exercise limitation or with contraindications to clinical exercise testing according to ATS recommendations for CPET
15. Patients with other relevant comorbidities that make the patient nor suitable to follow-up study procedures and/or could affect physical activity
16. Patients who cycled \< 2 minutes or \> 15 minutes during the constant work-rate exercise tests conducted at Visit 2 (Run-in Visit) or at Visit 3 even after adjustment of the work load.
17. Patients with history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
18. Patients for whom the use of anticholinergic drugs is contraindicated (acute urinary retention, symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma)
19. Patients unable to properly use a multidose dry powder inhaler or a pressurized metered-dose inhaler (pMDI).
20. Patients using any prohibited medication (including IMP within 30 days (or 6 half-lives, whichever is longer) before Visit 1) or who have not undergone the required washout period.
21. 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).
22. Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers, sleep apnea).
23. Patients unable to give their consent, or patients of consenting age but under guardianship, or vulnerable patients
C: Inclusion Criteria:

* • Men and women age 40 years and older

  * Current or former smoker of at least 10 pack-years
  * Diagnosis of Global Initiative for Chronic Lung Disease (GOLD) stage II, III or IV COPD as documented by pulmonary function
  * Are eligible for Pulmonary Rehabilitation

Exclusion Criteria:

* • Unable to perform mild exercises

  * Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
  * Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
D: Inclusion criteria:

All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:

post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio \< 70% (visit 1).

Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 \>50% and \< 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of \>=10 pack years.

Subjects must have a Medical Research Council (MRC) dyspnea score \>= 2.

Exclusion criteria:

Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.

Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.

Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

Answer: A