A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD

• Status: Completed
• Trial end date: 2018-01-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the dose-response relationship of different doses of CHF6001 and to identify the optimal dose (s) in terms of benefit/risk ratio for further development in the target patient population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Budesonide; Phosphodiesterase 4 Inhibitors

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