EUCTR2020-002356-20-HU进行中（未招募）1 期
Open label, prospective study to evaluate the effect of step-up from non-extrafine ICS/LABA DPI to extra fine triple therapy with CHF5993 DPI on airway geometry and lung ventilation using FRI in subjects with advanced COPD
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Subject’s signed Informed Consent Form obtained prior to any study-related procedure;
- •2. Male or female = 40 years of age;
- •3. Current smokers and/or ex-smokers of at least 10 pack-years
- •4. Established diagnosis of COPD according to the 2020 GOLD Report, prior to the Screening visit (V1);
- •5. Post-BD FEV1/FVC < 0.7 and FEV1 = 60% of predicted at V1
- •6. On a stable dose of any non-extrafine ICS/LABA DPI twice daily regimen for at least 8 weeks before screening;
- •7. Presence of lung hyperinflation based on the increase of Total Lung Capacity (TLC) exceeding either the upper limit of normal (ULN) or an empiric 120% of predicted, and/or a plethysmographic functional residual capacity (FRC) exceeding either ULN or 120 % of predicted;
- •8. Symptomatic subjects with CAT score = 10 at V1 and V2;
- •9. Documented history of = 1 moderate or severe COPD exacerbation in the previous 12 months prior to V1;
- •10. To have a cooperative attitude and the ability to be trained and use correctly the Dry Powder Inhalers (DPI);
- •11. To have a cooperative attitude and the ability to perform the required outcomes measurements (e.g. spirometry manoeuvres in sitting and supine position) and the ability to understand the risks involved;
- •12. WOCBP fulfilling one of the following criteria:
- •a. 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 visit or
- •b. WOCBP with non-fertile male partners (contraception is not required in this case)
- •13. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile; e.g. amenorrhea for = 12 consecutive months without alternative medical cause).
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Pregnant or lactating woman;
- •2. Exacerbations defined as a sustained and acute deterioration of subject’s symptoms and signs (dyspnoea, cough and/or sputum production/purulence) that are either moderate, i.e. require treatment with systemic (oral/IV/IM) corticosteroids and/or antibiotics, or severe, i.e. require hospitalization, if their associated treatment/hospitalization occurred within the 30 days before V1 (or 4 weeks in case the event was treated with just systemic corticosteroids) or if the event is recorded during the run-in period;
- •3. A current asthma diagnosis;
- •4. Respiratory disorders other than COPD
- •5. Cardiovascular diseases
- •6. Evidence or history of other concurrent disease
- •7. Medical history or current diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would have prevented use of anticholinergic agents;
- •8. History of lung transplant or lung reduction surgery;
- •9. ECG criteria: any clinically significant abnormal 12-lead ECG that in the investigator's opinion would affect efficacy or safety evaluation or place the subjects at risk. Male subjects with a QTcF >450msec and female subjects with a QTcF > 470msec at V1 are not eligible;
- •10. Laboratory abnormalities
- •11. Alcohol/drug abuse
- •12. Participation to investigational trial: subjects who have received any investigational drug within the 30 days or a more appropriate time as determined by the investigator (e.g. approximately 5 half-lives of the investigational drug, whatever is longer);
- •13. Contra-indications to IMPs, based on investigator judgement;
- •14. Hypersensitivity: 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;
- •15. Subjects mentally or legally incapacitated or subjects accommodated in an establishment as a result of an official or judicial order;
- •16. Documented COVID-19 diagnosis or its complications which have not resolved within 14 days prior to screening;
- •17. Positive molecular COVID-19 test within the last 72 hours before the remaining of screening activities.
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