Please select the eligibility criteria that correspond to the clinical trial below.
Title: To Investigate the PRevention of OM-85 on Bronchiectasis Exacerbation (iPROBE): a Multicenter, Randomised, Double-dummy, Placebo-controlled Clinical Trial in Chinese Patients
Brief Summary: Non-cystic fibrosis bronchiectasis is characterized by irreversible dilatation of the medium-sized bronchi as a result of airway injury due to recurrent or chronic inflammation and infection. Bronchiectasis airways are often colonized with bacterial species. Infections of the airways are thought to play an important role in bronchiectasis exacerbation. The non-specific prevention of recurrent airway infections by immunostimulating agents has gained growing scientific interest. OM-85, consisting extracts of eight kinds of bacteria important in respiratory infections, has shown the benefit for significantly reducing the incidence of exacerbations of chronic obstructive pulmonary disease (COPD). The purpose of this study is to investigate the PReventive effect of OM-85 on Bronchiectasis Exacerbation in Chinese patients (iPROBE).

This study is designed as a prospective randomised double-blind placebo-controlled multi-centred trial.


Options:
A: Inclusion Criteria:

* Moderate or severe COPD with insufficiency of the ventilatory pump (according to GOLD stage IV). Stable disease since four weeks or more prior to randomisation. The COPD might be caused by whatever reason (smoking, Alpha-1 antitrypsin deficiency, ....). Smokers can be included.
* Capillary PCO2 of 7 kPa (51,8 mmHg) or maximally 10 kPa (74 mmHg), combined with a pH of 7.35 or above. These gases must be measured after 30 minutes breathing room air in sitting position. Patients on long term oxygen treatment must inhale oxygen in their prescribed dose.
* Only patients in the age of 18 years or above can be included.
* Written information about all aspects of the study (available in German language) must be provided for each patient. Written informed consent prior to any measure of this protocol is necessary for inclusion.

Exclusion Criteria:

* Patients with a PCO2 of 10 kPa (74 mmHg) or above. These patients can be re-evaluated for inclusion after 4 weeks.
* Diseases of the lung or thorax besides COPD: Advanced pulmonary fibrosis, advanced bronchiectases, active tuberculosis, post tuberculosis syndrome, pneumonia, severe kyphoscoliosis, tracheostoma, neuromuscular diseases, or any other disorder, which might result in elevated PCO2.
* Patients on NIV.
* Body mass index of 35 kg/m² or above.
* Severe cardiac disease, NYHA IV, instable angina, severe cardiac arrhythmia, especially of ventricular origin (atrial fibrillation is not an exclusion criterion).
* Malignoma
* Disorders of the basal brain nerves with derangement of swallowing, or reflexes of swallowing and choking.
* Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus.
* Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study.
B: Inclusion Criteria:

* Between 40 and 80 at baseline visit
* Never smokers: \<1 pack-year history of smoking
* Never smokers: Must meet lung function criteria based on spirometry without inhaled bronchodilators
* Current or former smokers: \>20 pack-year history of smoking
* Current or former smokers: Must meet lung function criteria based on spirometry with inhaled bronchodilators

Exclusion Criteria:

* Dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures
* Plans to leave the area in the next 3 years
* Smoking history of \> 1 pack-year but \<21 pack-years
* BMI \> 40 kg/m2 at baseline exam
* Prior significant difficulties with pulmonary function testing
* Hypersensitivity to or intolerance of albuterol sulfate or ipratropium bromide or propellants or excipients of the inhalers
* Non-COPD obstructive lung disease, severe kyphoscoliosis, neuromuscular weakness, or other conditions, including clinically significant cardiovascular and pulmonary disease, that, limit the interpretability of the pulmonary function measures.
* History of Interstitial lung disease
* History of Lung volume reduction surgery or lung resection
* History of lung or other organ transplant
* History of endobronchial valve therapy
* History of large thoracic metal implants (e.g., AICD (automatic implantable cardioverter/defibrillator) and/or pacemaker)
* Currently taking \>=10mg a day/20mg every other day of prednisone or equivalent systemic corticosteroid
* Currently taking any immunosuppressive agent
* Current illicit substance abuse, excluding marijuana
* History of or current use of IV Ritalin
* History of or current use of heroin
* History of illegal IV drug use within the last 10 years or more than 5 instances of illegal IV drug use ever
* Known HIV/AIDS infection
* History of lung cancer or any cancer that spread to multiple locations in the body
* History of or current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator, limits the interpretability of the pulmonary function measures.
* Diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia
* Any illness expected to cause mortality in the next 3 years
* Active pulmonary infection, including tuberculosis
* History of pulmonary embolism in the past 2 years
* Known diagnosis of primary bronchiectasis
* Currently institutionalized (e.g., prisons, long-term care facilities)
* Known to be a first degree relative of another, already enrolled participant (i.e., biological parent, biological sibling)
* Never smokers only: Current diagnosis of asthma
* Women only: Cannot be pregnant at baseline or plan to become pregnant during the course of the study
C: Inclusion Criteria:

* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject. The Informed Consent form will be signed.
* Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the investigator.
* Subject with both genders is adult patients (\>18 years) diagnosed with bronchiectasis by high-resolution computed tomography (HRCT) of chest within 3 years of study inclusion having had at least 1 acute exacerbation in the previous year when recruiting.

Exclusion Criteria:

* History of cystic fibrosis;
* Hypogammaglobulinaemia;
* Allergic bronchopulmonary aspergillosis;
* Active tuberculosis;
* Subject has been assigned to treatment in a study of the medication under investigation in this study in the previous 6 months.
* Subject has a history of chronic alcohol or drug abuse within the last 6 months.
* Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.
* Subject has a known hypersensitivity to any components of OM85.
* Recent immunostimulant in last 3 months, cancer, stroke, severe cardiovascular disease, hepatic/kidney impairment, active TB, immuno-related diseases (RA and inflammatory bowel diseases), active ABPA.
* Subjects are free to withdraw from the study at any time, without prejudice to their continued care.
* Subject develops an illness that would interfere with his/her continued participation.
* Subject is noncompliant with the study procedures or medications in the opinion of the investigator.
* Subject takes prohibited concomitant medications as defined in this protocol (flu vaccine and pneumococcal vaccine).
* Subject withdraws his/her consent.
* There will have a confirmation of a pregnancy during the study, as evidenced by a positive pregnancy test.
* The sponsor or a regulatory agency requests withdrawal of the subject.
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