Clinical trial NCT01475292 (phase 2, status: completed)
Conditions: chronic obstructive pulmonary disease
ICD codes: J44.9, J44.1, J44.0
Drugs: rv568, rv568, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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.