A clinical study in which two different study drugs (CHF5993 and CHF1535) and placebo are administered with the same aerosol spray inhaler to evaluate the effect of study drugs on lung function parameters, exercise tolerance and physical activity in subjects with Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 21.1Level: LLTClassification code 10009032Term: Chronic obstructive lung diseaseSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-004718-36-PL
- Lead Sponsor
- Chiesi Farmaceutici S.p.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 102
1.A signed and dated written informed consent obtained prior to any study-related procedures
2.Outpatient population
3.Male or female subjects > 40 years at Screening visit
4.COPD diagnosis for at least 12 months before the Screening visit according to the definition by the GOLD 2020 report
5.Current or ex-smokers (who quit smoking for at least 6 months prior to Screening Visit) with a smoking history of at least 10 pack-years
6.A post-bronchodilator FEV1/FVC < 0.7 within 30 min after 4 puffs (4 x 100 µg) of salbutamol pMDI and a post-bronchodilator FEV1 = 40% and <80% of the predicted normal values.
7.Pre-bronchodilator functional residual capacity (FRC) of > 120% of predicted normal FRC values at Screening visit 1.
8.A score of >2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Visit 1
9.Subjects on mono- or dual inhaled maintenance COPD treatment at a stable dose for at least 3 months prior to screening
10.A cooperative attitude and ability to correctly use the study inhalers
11.Female subjects must be women either of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) or physiologically capable of becoming pregnant (i.e. women 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 contact or
•WOCBP with non-fertile male partners (contraception is not required in this case)
Inclusion criteria assessed prior to Randomization:
12.CWRCE at Visit 1b: between 2 min and 11 min at 80% of maximum workload. In case the subject cycles for a shorter (i.e. < 2 min) or longer (i.e. > 11 min) period, the visit can be repeated with an adjusted workload once within a 1-week period
13.Oxygen saturation (SpO2 measured by pulse oximeter) at least 82% during the incremental exercise test (IET) performed in the run-in period
14.Subjects must be able to complete CWRCE at Visit 1b and then at Visit 2 without requirement for supplemental oxygen
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 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34
1.Pregnant or lactating women.
2.Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator’s judgment.
3.Unstable concurrent disease which may impact the efficacy or the safety of the study drug according to investigator’s judgment.
4.Any other disease/condition which in the opinion of investigator is likely to impact subject’s cardiopulmonary status or the ability to perform functional (exercise) testing during the study.
5.Evidence of symptomatic advanced peripheral artery disease.
6.Moderate (requiring prescriptions of systemic corticosteroids and/or antibiotics) or severe (leading to hospitalization) COPD exacerbation in the 3 and 12 months, respectively, prior to Screening visit 1 and during the run-in period
7.Lung transplant or lung volume reduction surgery (subjects with lung volume reduction surgery are excluded if the procedure was performed within 1 year before the Screening visit)
8.Subjects requiring long term (> 15 hours a day) oxygen therapy for chronic hypoxemia
9.Subjects who have clinically severe cardiovascular condition which may impact the efficacy or the safety of the study drug according to the investigator’s judgement
10.An abnormal and clinical.ly significant 12-lead ECG which may impact the safety of the subject according to investigator’s judgement. Subjects whose electrocardiogram (ECG) (12 lead) shows QTcF >450 ms for males or QTcF >470 ms for females at screening or at randomisation visits are not eligible.
11.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
12.History of hypersensitivity to M3 receptor antagonists, ß2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator’s judgement
13.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
14.Subjects with body mass index less than 15 or greater than 35 kg/m2
15.Malignancy that has not been in complete remission for at least 1 year or any untreated (e.g. resected for cure) localized carcinomas
16.History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit
17.Subjects who are mentally or legally incapacitated, or subjects incarcerated as a result of an official or judicial order
18.Subjects who are in the acute phase of pulmonary rehabilitation program within 1 month before the Screening visit or planning to enrol in the acute phase of such program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded
19.Subjects with contraindications to cardiopulmonary exercise testing, including those whose exercise test is limited by non-respiratory or cardiovascular condition, e.g. by neurologic, orthopaedic, or other disorders
20.Participation in another clinical trial where investigational drug was received less than 30 days or 5 half-lives whichever is longer prior to screening visit
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