A study in Chronic Obstructive Pulmonary Disease patients to evaluate the efficacy and safety of 4 different doses of a new medicine, CHF 6001 given for 6 months

Phase 1

• Conditions: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); MedDRA version: 19.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-005548-32-BG
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-20
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1102

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 6.With a documented history (e.g. medical record verification) of at least 1 moderate or severe exacerbation in the 12 months prior to study entry.
7.Patients must be symptomatic at screening defined as having a MMRC score =2 and a CAT score =10.
8.Patients must be receiving daily maintenance therapy with an ICS/LABA only, at stable dose and dosage regimen, for at least 2 months prior to screening.
9.Patients must have a cooperative attitude and ability to be trained to use correctly the DPI inhalers.
10.Patients must have a cooperative attitude and ability to be trained to use correctly the electronic devices with COPD questionnaire, to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres, ) and ability to understand the risks involved.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 734
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 367

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified