CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: CHF 6001 NEXThaler 100µg
Product Code: CHF 6001
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: CHF 6001 NEXThaler DPI
Current Sponsor code: CHF6001.00
Concentration unit: µ
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female aged =40 years with written informed consent. 2.A female is eligible to enter the study if she is of non- childbearing potential i.e. physiologically incapable of becoming pregnant or woman permanently sterilized 3.With an established diagnosis of COPD (according to GOLD guidelines, revised 2015(1)) at least 12 months prior to the screening visit. 4.With a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20]. Current and ex-smokers are eligible. 5.With a post-bronchodilator FEV1 >/=30% and =65 years) yes F.1.3.1 Number of subjects for this age range 367
Exclusion criteria
Exclusion criteria: 1. A diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation 2.On maintenance bronchodilators therapy only (LABA alone, LAMA alone, dual LABA/LAMA) within 8 weeks prior to screening. 3.On maintenance triple therapy (ICS/LABA plus LAMA), or LAMA plus ICS combination therapy, or on PDE4 inhibitors (e.g. roflumilast) within 8 weeks prior to screening. 4.Moderate or severe COPD exacerbation or a lower respiratory tract infection within 6 weeks prior to study entry or during the run-in period. 5.Requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia. 6.Participating to a pulmonary rehabilitation programme or completing such a programme within the last 6 weeks prior to screening. 7.Known respiratory disorders other than COPD that in the investigator’s opinion would affect efficacy and safety evaluation or place the patient at risk. 8.Lung cancer or a history of lung cancer. 9.Active cancer or a history of cancer with less than 5 years disease free survival time. Localized carcinoma is acceptable. 10.A history of hypersensitivity to ß2-agonist, corticosteroids, PDE4 inhibitors or any of the excipients contained in any of the formulations used in the trial. 11.Diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour that might, according to the investigator judgement, place the patient at undue risk. 12.Clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, NYHA Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to study entry, not controlled with a rate control strategy. 13.Clinically significant abnormal 12-lead ECG that, in the investigator’s opinion, would affect efficacy or safety evaluation or place the patient at risk. 14.Serum potassium value =3.5 mEq/L or >5.5mEq/L and/or a fasting serum glucose value = 140 mg/dL. 15.History or symptoms of significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances. 16.Unstable concurrent disease or other disease or condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study. 17.Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study. 18.Abnormal ALT =2x upper limit of normal (ULN) and/ or AST =2x ULN and/or bilirubin =1.5x ULN. Isolated bilirubin =1.5x ULN is acceptable if fractionated and direct bilirubin is <35%. 19.Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones). 20.Receiving treatment with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) within the previous 3 months before the screening visit. 21.Severely obese (BMI =35 kg/m2) or have experienced excessive weight loss recently. 22.History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit. 23.Received any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial will be to investigate the dose-response relationship of 4 doses of CHF 6001 DPI with respect to predose FEV1 after 12 weeks of treatment and to identify the optimal dose of CHF 6001 for further development in the target patient population.;Secondary Objective: - To assess the efficacy of the different doses of CHF 6001 DPI in comparison with placebo on other lung function parameters (pre-dose FVC, IC), on symptoms benefit (TDI, SGRQ score, E-RS scores, rescue use) and on exacerbations reduction after 24 weeks of treatment; - To evaluate the effect of CHF 6001 in comparison with ICS; - To monitor for safety and tolerability.;Primary end point(s): Primary efficacy variable •Change from baseline in morning predose FEV1 at week 12. ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy variables •Change from baseline in morning predose FEV1. •Change from baseline in morning predose morning FVC and IC. •TDI score at all visits and proportion of patients with a TDI =1 unit •Change from baseline to all visits in SGRQ total score and domain scores and proportion of patients with a change from baseline in SGRQ score = -4 units. •Moderate and severe COPD exacerbation rate over 24 weeks of treatment. Time to first moderate or severe COPD exacerbation.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Bulgaria, Germany, Hungary, Poland, Romania, Russian Federation, Ukraine, United Kingdom
Contacts
Public ContactCLINICAL PROJECT MANAGER
Chiesi Farmaceutici S.p.A.
Outcome results
None listed