CTIS2023-503333-22-00招募中1 期
A 12-week double-blind, multicentre, randomised, active-controlled, 2-arm, parallel-group clinical trial to evaluate the safety of CHF5993 pMDI 200/6/12.5 µg HFA-152a, compared to CHF5993 pMDI 200/6/12.5 µg HFA-134a, in subjects with asthma - CLI-05993AB6-03
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 777
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Subject’s written informed consent obtained prior to any study related procedure;, Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read/write, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved. Subjects who already use a spacer device will be asked to use one for inhalation of their pMDI medication;, Female subjects fulfilling one of the following criteria: a.Woman of childbearing potential (WOCBP) fulfilling one of the following criteria: •WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up call or •WOCBP with non-fertile male partners (contraception is not required in this case). b.Female subject of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e., post-menopausal or permanently sterile). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per Investigator’s request, post-menopausal status may be confirmed by follicle-stimulating hormone (FSH) levels (according to local laboratory ranges)., Male and female adults aged = 18 and = 75;, Body mass index (BMI) within the range of 18.0 to 35.0 kg/m2 inclusive, Non-smokers or ex-smokers who smoked < 10 pack-years (pack-years = the number of cigarette packs per day x the number of years) and stopped smoking > 1 year (6 months for e-cigarettes) prior to screening;, Diagnosis of asthma: physician-diagnosed asthma for at least 6 months and with diagnosis before the age of 50 years;, Stable asthma therapy: a stable treatment with medium/high doses of inhaled corticosteroids (ICS) + long-acting ß-agonist (LABA) + long-acting muscarinic antagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium and high-dose ICS defined as BDP non-extrafine > 500-1000 µg and > 1000 µg respectively, or estimated clinical comparable dose). Subjects who inhale their pMDI medication with a spacer will be required to keep using a spacer for the study medication throughout the entire duration of the study, Asthma control: controlled or partly controlled based on an Asthma Control Questionnaire 7 items (ACQ-7) score < 1.5 at screening and at randomisation, Subjects with a pre-bronchodilator 40% < forced expiratory volume in 1 second (FEV1) < 90% of their predicted normal value, after appropriate wash-out from bronchodilators, at the screening visit;, Subjects with a positive bronchodilator response at screening defined as an increase in FEV1 = 12% and 200 mL over baseline within 30 minutes after inhalation of 400 µg salbutamol pMDI; Note: in case the bronchodilator (BD) response threshold is not met at screening, the spirometry test can be repeated no later than 1 day before randomisation at a second spirometry visit. In case the BD response is not met at this second spirometry visit, historical documentation of BD response can be provided. Historical documentation of BD response defined according to the 2005 American Thoracic Society (ATS)/European Respiratory Society (ERS) Task Force on interpretative strategies for lung function tests, or history of positive bronchial challenge test (methacholine) wi
排除标准
- •History of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the Investigator may place the subject at undue risk, emergency room access for asthma in the previous 6 months before enrolment;, Previous medical history, evidence of an uncontrolled, severe, intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis that in the opinion of the Investigator and/or Medical Monitor may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject’s ability to participate in the study. Subjects with well-controlled comorbid disease (e.g., hypertension, hyperlipidaemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to screening are eligible;, Contra-indications to investigational medicinal products. For warnings, eligibility will be judged by the Investigator;, History of hypersensitivity to any of the study medications components or a history of other allergy that in the opinion of the Investigator contraindicates the subject’s participation;, Subjects with a medical history or current diagnosis of narrow-angle glaucoma, symptomatic prostatic hypertrophy, urinary retention bladder neck obstruction that, in the opinion of the Investigator, would prevent use of anticholinergic agents;, Subjects using SCS medication in the 4 weeks prior to screening (6 weeks prior to randomisation) or slow-release corticosteroids in the 12 weeks before screening (14 weeks prior to randomisation);, Prohibited medication: subjects receiving treatment with one or more drugs listed in the non-permitted concomitant medications section (see section below);, Clinical evidence of candidiasis at the oropharyngeal examination at screening or randomisation (to be re-checked prior to randomisation);, Documented coronavirus disease 2019 (COVID-19) diagnosis within the previous 2 weeks, or associated complications/symptoms, which have not resolved within 14 days prior to screening (to be re-checked prior to randomisation);, Alcohol/drug abuse: subjects with a known or suspected history of alcohol and/or substance/drug abuse within 12 months prior to screening (to be re-checked prior to randomisation);, Participation in other investigational trial(s): subjects who have received any investigational drug within the 30 days (60 days for biologics) or a more appropriate time as determined by the Investigator (e.g., approximately 5 half-lives of the investigational drug whatever is longer) (to be re-checked prior to randomisation);, Asthma exacerbation requiring systemic corticosteroids (SCS) or emergency room admission or hospitalisation within 4 weeks prior to study entry and/or during the run-in period (to be checked again prior to randomisation);, Pregnant or lactating women. Pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive pregnancy test. Serum and urine pregnancy tests will be performed at the screening visit. The urine pregnancy test will be repeated at the randomisation visit;, e-Diary completion compliance < 60% at randomisation, Vaccination: subjects having received a vaccination within 2 weeks prior to screening or during the run-in., Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;, Asthma subjects curr
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