A Study to Investigate How Safe and Well Tolerated RV568 is in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Study to Investigate How Safe and Well Tolerated RV568 is in Patients With Chronic Obstructive Pulmonary Disease (COPD)
RV568 is being developed as a possible treatment of diseases such as smoking related lung
 disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma.

 The main purpose of this study is to examine the safety of RV568 in COPD patients. Two dose
 strengths of RV568 and a placebo will be tested in this study, which will be given by
 inhaling a liquid suspension from a nebuliser once a day for 2 weeks.
Inclusion Criteria:

 -  Male or female aged 40-75 years inclusive at the time of signing the informed consent.

 -  Capable of giving written informed consent, which includes compliance with the
 requirements and restrictions listed in the consent form.

 -  COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic
 Society (ATS)/European Respiratory Society (ERS) guidelines, with symptoms compatible
 with COPD for at least 1 year prior to screening.

 -  Severity of Disease: subjects who conform to the current severity classification for
 GOLD Stage II/III disease in terms of post-bronchodilator spirometry at screening
 (Post-salbutamol FEV1/FVC ratio of ≤ 0.70 and post-salbutamol FEV1 ≥ 40 % and ≤ 80 %
 of predicted normal values calculated using ECCS reference equations)

 -  Demonstrated ability to use the I-neb AAD system at screening.

 -  Subject is a current or previous smoker with a smoking history of ≥ 10 pack years

 Exclusion Criteria:

 -  A history of life-threatening COPD including Intensive Care Unit admission and/or
 requiring intubation

 -  A history of > 1 hospitalisation for COPD in the previous 2 years prior to screening.

 -  Evidence of cor pulmonale or clinically significant pulmonary hypertension or chronic
 (in the opinion of the Investigator) use of oxygen.

 -  Upper or lower respiratory tract infection, including exacerbation of COPD, within 6
 weeks of screening.

 -  Other respiratory disorders: Subjects with a current diagnosis of asthma, active
 tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial
 lung diseases or other active pulmonary diseases.

 -  Subjects with a history of chronic disease including, but not limited to, sleep
 apnoea, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal,
 hematological, urological, immunological, or ophthalmic diseases that the Investigator
 believes are clinically significant.

 -  Previous lung resection or lung reduction surgery.

 -  Pregnant or nursing females.

 -  Any abnormal or clinically significant ECG or laboratory values that the Investigator
 considers would put the subject at risk through participation. A subject with a
 clinical abnormality or laboratory parameters outside the reference range for the
 population being studied may be included if the Investigator and the sponsor
 representative agree it is unlikely to introduce additional risk factors and will not
 interfere with study procedures.

 -  ALT > 2 x ULN at the screening visit.

 -  A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody
 result, or positive test for HIV antibody at the screening visit (or within the 3
 months prior to screening).

 -  Positive test for drugs of abuse at screening that cannot be satisfactorily explained
 by a prescription history (e.g., recent use of codeine tablets).

 -  History of alcohol abuse within the previous 6 months

 -  Has had major surgery, (requiring general anesthesia) within 6 weeks before the
 screening visit, or will not have fully recovered from surgery, or planned surgery
 through the end of the study

 -  Participated in any other clinical study of an NCE within 3 months, or in a study of a
 marketed drug within 1 month (or within 5 half-lives of the NCE or marketed drug,
 whichever is the longest) of first dose; or has participated in 4 studies in the
 previous 12 months.

 -  A disclosed history, or one known to the Investigator, of significant noncompliance in
 previous investigational studies or with prescribed medications.

 -  Allergy to any of the active or inactive ingredients in the study medication, or
 history of drug, or other allergy that, in the opinion of the Investigator or
 RespiVert medical monitor, would contraindicate their participation.

 -  Donation of blood in excess of 500 mL within a 3 month period prior to dosing, or if
 study participation would result in blood loss in excess of 500 mL in a 3 month
 period.

 -  Subject is mentally or legally incapacitated.

 -  Has any condition or are taking a medication that, in the opinion of the Investigator,
 would make participation not be in the best interest (i.e., compromise the well-being)
 of the subject or that could prevent, limit, or confound the protocol-specified
 assessments.

 -  Is an employee of the Investigator or study site, with direct involvement in the
 proposed study or other studies under the direction of that investigator or study
 site, as well as family members of the employees or the Investigator.

 -  Any other reason that the Investigator considers makes the subject unsuitable to
 participate.

 -  Subject has a history of unstable, or uncontrolled hypertension, or has been diagnosed
 with hypertension in last 6 months.