Chronic Obstructive Pulmonary Disease Clinical Trial
— PIONEEROfficial title:
A 24-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF6001 DPI in Patients With COPD on a Background Therapy
Verified date | January 2019 |
Source | Chiesi Farmaceutici S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1130 |
Est. completion date | January 9, 2018 |
Est. primary completion date | October 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 ß2-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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chiesi Farmaceutici S.p.A. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in predose morning FEV1 at 12 weeks | overall effect of CHF6001 on change from baseline in predose morning FEV1 | week 12 | |
Secondary | Change from baseline in predose morning FEV1 at other timepoints | Change from Baseline | weeks 3, 6, 18, 24 | |
Secondary | Change from baseline in pre-dose morning IC | Change from Baseline for other lung function parameters | weeks 3, 6, 12, 18, 24 | |
Secondary | Change from baseline in pre-dose morning FVC | Change from Baseline for other lung function parameters | weeks 3, 6, 12, 18, 24 | |
Secondary | Change from baseline in TDI focal score | Change of TDI score | weeks 3, 6, 12, 18, 24 | |
Secondary | Change from baseline in SGRQ score | Change of SGRQ score | weeks 3, 6, 12, 18, 24 | |
Secondary | Change from baseline in E-RS score | Change of E-RSI score | weeks 3, 6, 12, 18, 24 | |
Secondary | COPD exacerbation rate over 24 weeks of treatment | exacerbation rate | 24 weeks | |
Secondary | Time to first COPD exacerbation | Time to first COPD exacerbation | 24 weeks |
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