A clinical study to evaluate efficacy, safety and tolerability of a drug CHF 5993 with a drug CHF 1535, both administered via Pressurised Metered Dose Inhaler in subjects with chronic obstructive pulmonary disease
- Conditions
- Chronic obstructive pulmonary disease (COPD)Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-510172-31-00
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2394
signed and dated written informed consent must be obtained prior to initiating any study related procedures, Subjects receiving daily inhaled maintenance therapy for their COPD, at a stable dose for at least 3 months prior to the screening and randomization visits, Documentation (including imagery and report) of chest x-ray (CXR) or CT scan performed within 6 months prior to the screening visit, without evidence of significant abnormalities (other than those related to the presence of COPD)., A cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary, Outpatient population, Male or female subjects aged >40 years, For Woman of Childbearing Potential with fertile / non-fertile male partners and for Female subjects of nonchildbearing potential, COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report, Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years, Symptomatic subjects based on COPD Assessment Test (CAT) score = 10, A pre- and post-bronchodilator FEV1/FVC ratio <0.70 at screening, A post-bronchodilator FEV1 <50% predicted normal at screening and a documented history of =1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV1 =50% and <80% of predicted normal at screening and a documented history of =2 moderate COPD exacerbations or =1 severe COPD exacerbation in the previous 12 months Global Lung Function Initiative reference equations will be used to calculate percent predicted values (for COPD exacerbation details see study protocol).
Female subjects who are pregnant (as evident by a positive urine hCG or serum ß-hCG test) or lactating, Subject has severe, acute or uncontrolled cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class IV, left ventricular failure, acute myocardial infarction or unstable angina) in the last 6 months, An abnormal and clinically significant 12-lead ECG at either the screening or randomization visit., Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement, Unstable or uncontrolled concurrent disease which may impact the efficacy or safety of the study drug or the subject's participation in the study according to investigator's judgment, Malignancy that has not been in complete remission for at least 1 year or any untreated (e.g. resected for cure) localized carcinomas. For complete list of exclusion criteria see protocol., Subjects using the following medications prior to the screening visit and during the run-in period: a. Systemic/oral/parenteral corticosteroids in the prior 4 weeks b. Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks c. Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks d. Oral xanthine derivatives (e.g. theophylline) in the prior 7 days, A moderate or severe COPD exacerbation or a lower respiratory tract infection (e.g., pneumonia) that has not resolved =14 days prior to the screening visit or during the run-in period, Subjects being treated with non-cardioselective ß-blockers, Subjects requiring long term (> 15 hours daily) oxygen therapy, Known respiratory disorders other than COPD which may impact the efficacy of the study drug according to investigator's judgement., Lung transplant surgery or lung volume reduction surgery, Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents, History of hypersensitivity to M3 receptor antagonists, ß2 agonists, corticosteroids or any of the excipients contained in any of the study drugs used in the trial which may raise contraindications or impact the efficacy of the study drug according to the investigator's judgement
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