Clinical trial NCT02986321 (phase 2, status: completed)
Conditions: chronic obstructive pulmonary disease
ICD codes: J44.9, J44.1, J44.0
Drugs: chf6001, budesonide, placebo
SMILES: CS(=O)(=O)NC1=CC=C(C=C1OCC1CC1)C(=O)O[C@@H](CC1=C(Cl)C=[N+]([O-])C=C1Cl)C1=CC=C(OC(F)F)C(OCC2CC2)=C1, COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  COPD patients

          -  Non- childbearing potential or woman permanently sterilized or on one or more highly
             effective contraception

          -  Current/ex smokers (history > 10 pack years)

          -  Post bronchodilatator FEV1 >=30% and <=70% predicted normal value and FEV1/FVC ratio
             <0.7

          -  Documented history of at least 1 moderate or severe exacerbation in the 12 months
             prior to study entry

          -  Symptomatic patients (MMRC score ≥2 and a CAT score ≥10)

          -  Patients on daily maintenance therapy with an ICS/LABA .

        Exclusion Criteria:

          -  Diagnosis of asthma or other respiratory disorders

          -  Maintenance bronchodilators therapy only (eg LABA alone)

          -  Maintenance triple therapy.

          -  Occurrence of a moderate or severe COPD exacerbation within 6 weeks prior to study
             entry or during the run-in period.

          -  Patients requiring long term oxygen therapy.

          -  Concomitant or recent pulmonary rehabilitation programme

          -  Known respiratory disorders other than COPD

          -  Lung cancer or a history of lung cancer, active or history of cancer with less than 5
             years disease free survival time

          -  Hypersensitivity to β2-agonist, corticosteroids, PDE4 inhibitors or any of the
             excipients

          -  Depression, generalised anxiety disorder, suicidal ideation

          -  Any clinically significant cardiovascular disease (IM, CHF III/IV; AF not controlled
             by therapy, etc) within 1 year of study entry

          -  Any relevant clinically significant cardiovascular condition, clinically abnormal
             significant 12-lead ECG (QTcF>450 ms for male and >470 for female) or clinically
             significant laboratory abnormalities

          -  Serum potassium value ≤3.5 mEq/L or >5.5mEq/L and/or a fasting serum glucose value
             ≥140 mg/dL.

          -  History or symptoms of significant neurological disease

          -  Unstable concurrent disease: eg uncontrolled Thyroid disease or other endocrine
             diseases, gastrointestinal uncontrolled disease, uncontrolled immune diseases

          -  Renal impairment.

          -  Patients with abnormal alanine aminotransferase and/ or aspartate aminotransferase
             and/or bilirubin

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities
             and patients receiving treatment with any drug known to have a well defined potential
             for hepatotoxicity before Study entry

          -  Severely obese (BMI ≥35 kg/m2) or have experienced excessive weight loss recently

          -  History of alcohol abuse and/or substance/drug abuse within 12 months prior to
             screening visit.

          -  Any recent participation to a clinical Study with other investigational drug