A phase IV, open label, multicentre, randomised, 2-way cross-over exploratory clinical trial comparing a fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrronium administered via pMDI (TRIMBOW®) and a fixed combination of fluticasone furoate plus vilanterol administered via DPI (RELVAR® ELLIPTA®) on lung stiffness reduction assessed through area under the reactance curve (AX) using forced oscillation technique (FOT) in patients with chronic obstructive pulmonary disease (COPD). - CLI-05993AA1-21 - TRIMBOW Study

Chiesi Farmaceutici S.p.A.0 sites36 target enrollmentOctober 28, 2019

DrugsTRIMBOW®RELVAR® ELLIPTA®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Chiesi Farmaceutici S.p.A.
Enrollment: 36
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 28, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Chiesi Farmaceutici S.p.A.

Eligibility Criteria

Inclusion Criteria

•\- Patients with established diagnosis of COPD at least 12 months prior to the screening visit (according to GOLD Report, revised 2019\). Patients with a diagnosis of Asthma COPD Overlap Syndrome (ACOS) and with a current diagnosis of atopy or allergic rhinitis based on their medical history and investigator judgement will be also eligible for inclusion.
•\- Current smokers or ex\-smokers, who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years \[pack\-years \= (number of cigarettes per day x number of years)/20]. If patients underwent any kind of smoking cessation therapy, it should be finished at least 2 months prior to screening.
•\- A post\-bronchodilator FEV1 \<60 % of the predicted normal value and a post\-bronchodilator FEV1/FVC \< 0\.7 within 30 min after 4 puffs (4 x 100 µg) of salbutamol pMDI.
•\- Patients under double or triple therapy for at least 2 months prior to screening visit in stable doses and regimens with either:
•a.inhaled corticosteroids/long\-acting ß2\-agonist combination (ICS/LABA) (fixed or free), or
•b.inhaled corticosteroids/long\-acting muscarinic antagonist free combination (ICS/LAMA), or
•c.Inhaled long\-acting ß2\-agonist / long\-acting muscarinic antagonist (LABA/LAMA) (fixed or free), or
•d.fixed or free combination of an inhaled corticosteroid /long\-acting ß2\-agonist/long\-acting muscarinic antagonist (ICS/LABA/LAMA)
•\- A cooperative attitude and ability to correctly use the study inhalers and spacer.
•\- Female patients must be 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:

Exclusion Criteria

•\- Diagnosis of asthma.
•\- Patients requiring use of the following medications:
•i.A course of systemic steroids longer than 3 days for COPD exacerbation in the 4 weeks prior to screening.
•ii.A longer than 7\-day course of antibiotics for the treatment of COPD exacerbation in the 4 weeks prior to screening.
•iii.Use of antibiotics for a lower respiratory tract infection (e.g pneumonia) in the 4 weeks prior to screening.
•\- COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run\-in period.
•\- Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
•\- Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator’s judgment. This can include but is not limited to alfa\-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
•\- Patients who have clinically severe cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV, left ventricular failure, acute myocardial infarction, not controlled arrhythmia etc.), which may impact the efficacy or the safety of the study drug according to the investigator’s judgement.
•\- An abnormal and clinically significant 12\-lead ECG which may impact the safety of the patient according to investigator’s judgement. Patients 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. The QTcF criterion should not be applicable to patients with pacemaker or permanent atrial fibrillation.