The efficacy and the safety of two doses of CHF6001 for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD) and Chronic BronchitisMedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-003666-40-HU
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2985
1.Males and females aged = 40 years with written informed consent obtained prior to any study-related procedure.
2.Females are eligible to enter the study if they are of
a.non-childbearing potential
or
b.childbearing potential, they must have a negative pregnancy test at screening and must agree to use one or more of the acceptable contraceptive measures.
3.Subjects with an established diagnosis of COPD with chronic bronchitis
4.Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years.
5.A post-bronchodilator FEV1 < 80% of the subject predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 after 400µg (4 puffs x 100µg) of salbutamol pMDI.
6.A documented history (e.g. medical record verification) of at least one moderate or severe COPD exacerbation in previous year.
7.Symptomatic subject at screening defined as having a CAT score = 10.
8.Subjects on regular maintenance triple therapy (free or fixed combination of ICS, LABA, LAMA) according to GOLD 2020 recommendations, for at least 12 months prior to screening.
9. Subjects are willing and able to be trained to use correctly the DPI inhalers (NEXThaler®).
10.Subjects are willing and able to be trained to use correctly the electronic devices with COPD questionnaires, to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres etc.) 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 1985
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000
1.Subjects with a diagnosis of current asthma.
2.Subjects with a moderate or severe COPD exacerbation 4 weeks prior to study entry and during run-in period.
3.Pregnant and lactating women.
4.Subjects requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
5.Subjects with known a-1 antitrypsin deficiency as the underlying cause of COPD
6.Subjects with COPD primarily emphysema phenotype as per investigator judgement and medical history records
7.Subjects with clinically significant respiratory disorders other than COPD.
8.Subjects with lung volume reduction surgery.
9.Subjects having lung cancer or a history of lung cancer or lung cancer resection in the past.
10.Subjects with active cancer or a history of cancer (other than the lung) with less than 5 years disease free survival time.
11.Subjects with a history of allergy or hypersensitivity to anticholinergics, ß2-agonists, corticosteroids, PDE-4 inhibitors or any of the excipients contained in any of the formulations used in the trial or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the investigator’s opinion would contra-indicate study participation.
12.Subjects under Roflumilast treatment within 6 months before study entry
13.Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour that might, according to the investigator judgement, place the subject at undue risk.
14.Subjects who have clinically significant cardiovascular condition.
15.An abnormal and clinically significant 12-lead ECG finding in relation to the subject’s medical history that results in active medical problem which may impact the safety of the subject according to investigator’s judgement.
16.Subjects with a significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances that in investigator’s opinion, would place the subject at risk by participating to the study.
For complete list of exclusion criteria, please refer to the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of two doses of CHF6001 add-on to maintenance triple therapy (ICS, LABA, LAMA) to reduce the rate of moderate and severe exacerbations after 52 weeks of treatment in comparison with maintenance triple therapy (i.e. placebo arm).;Secondary Objective: To evaluate<br>- the efficacy of the two doses of CHF6001 add-on to maintenance triple therapy on health related quality of life after 52 weeks of treatment (change in SGRQ total score).<br>-the efficacy of the two doses of CHF6001 add-on to maintenance triple therapy on lung function, health-related quality of life, severe exacerbations in the pooled analysis of CLI-06001AA1-04 and CLI-06001AA1-05 studies and other clinical outcome measures in comparison with maintenance triple therapy<br>-the safety and tolerability of the two doses of CHF6001<br>;Primary end point(s): Annual rate of moderate and severe exacerbations over 52 weeks;Timepoint(s) of evaluation of this end point: Over 52 weeks
- Secondary Outcome Measures
Name Time Method