A trial to assess the efficacy and safety of 3 doses of CHF 6532 (10, 25 or 50 mg two times a day) compared to placebo on top of standard of care in subjects with uncontrolled severe eosinophilic asthma.
- Conditions
- Severe Eosinophilic AsthmaMedDRA version: 21.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2018-003548-22-PL
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1640
1.Informed consent: Subjects’ written informed consent or Adolescents legal representative’s informed consent obtained prior to any study-related procedures.
2.Gender & Age: Male or female subjects aged =12 years and =75 years.
3.Asthma diagnosis: Subjects with a diagnosis of asthma (according to GINA) for a period of at least 24 months prior to screening.
4.Previous medication: Subjects treated according to GINA step 4/5:
- with stable high-dose inhaled corticosteroids (ICS) plus a long-acting ß2 agonist (LABA)
- with or without long-acting muscarinic antagonist (LAMA) or alternate therapy Leukotriene Receptor Antagonist or theophylline (except asthma anti-inflammatory monoclonal antibodies (e.g. omalizumab, mepolizumab, reslizumab, etc.) or any other biologics)
- with or without Oral corticosteroid (OCS) at stable dose not above 20 mg/days eq.
if taken at stable dose for at least 4 weeks prior to screening.
5.Asthma exacerbation history
6.A positive response to a reversibility test at screening
7.Blood eosinophils level: Subjects with evidenced eosinophilic airway inflammation as reflected by a peripheral blood eosinophil count =250/µL blood eosinophils level at screening visit.
8.ACQ-5: Subjects with uncontrolled asthma as evidenced by an Asthma Control Questionnaire © (ACQ-5) score =1.5 at screening and randomisation visits.
9. A co-operative attitude and ability:
-to perform all trial related procedures including technically acceptable pulmonary function tests;
-to correctly use the electronic diary/peak flow meter.
10.Ability of subjects to swallow tablets.
Are the trial subjects under 18? yes
Number of subjects for this age range: 248
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1392
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are using one or more of the reliable methods of contraception
2.Run-in compliance < 50% at randomisation
3.Asthma exacerbation or Respiratory tract infection: Hospitalisation, emergency room admission or use of systemic corticosteroids for an asthma exacerbation or respiratory tract infection in the 4 weeks prior to screening visit or during the run-in period.
4.Subjects with a history of near fatal asthma or of a past hospitalisation for asthma in intensive care unit which, in the judgement of the investigator, may place the subjects at undue risk.
5.Bacterial lower respiratory tract infection: Subjects with a history of more than 2 episodes of confirmed bacterial lower respiratory tract infection within the year prior to screening or with a bacterial lower respiratory tract infection during the run-in.
6. History of diagnosis of COPD, cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
7.ECG criterion: with a marked resting baseline prolongation of mean QTc interval
8. Subjects with a family history of long QT Syndrome.
9.Subjects with hypokalemia (serum K< 3.5 mmol/L) at screening.
10.Subjects who have known clinically significant cardiovascular conditions
11.Subjects with a history of symptoms or significant neurological disease
12.Subjects with clinically significant abnormal serum biochemistry, haematology (not associated with the study indication) at screening according to the investigators judgement.
13.Current smokers or ex-smokers with total cumulative exposure =10 pack-years or having stopped smoking less than one year prior to screening visit.
14.Subjects with historical or current evidence of uncontrolled concurrent disease
15.Subjects with a history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
16.Subjects receiving treatment with any drug known to have a well-defined potential for hepatotoxicity within the previous 3 months before the screening visit.
17.Subjects receiving treatment with one or more drugs listed in the prohibited medication section.
18.Regular use of oral or systemic corticosteroids for diseases other than asthma within the past 12 months or any intra-articular or short-acting, intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroids within 3 months prior to screening.
19.Subjects with severe hepatitis, chronic active hepatitis or evidence of uncontrolled chronic liver disease
20.Subjects with ALT or AST at screening =2xULN.
21.Subjects with other severe acute or chronic medical or malignancy or psychiatric conditions which are uncontrolled or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and would make the subjects inappropriate for entry into this study.
22.Subjects with a history of lung volume resection.
23.Lung cancer or history of lung cancer: Subjects with a diagnosis of lung cancer or a history of lung cancer.
24.Cancer or history of cancer (other than lung): Subjects with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localised
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method