A Study Comparing the Effects of Trimbow to Fostair in COPD

Inclusion Criteria:

1. Male and female adults aged 40 to 75 years with written informed consent obtainedprior to any study-related procedure.

2. COPD diagnosis: Subjects with a diagnosis of moderate to severe COPD according to theGOLD 2018 COPD recommendations, with symptoms compatible with COPD for at least 1 yearprior to screening.

3. Clinically stable COPD in the 6 weeks prior to screening and during the run-in periodprior to randomisation.

4. Body mass index (BMI) in the range of 18.0 to 33.0 kg/m2 and with a minimum weight of 50 kg at screening.

5. Current smokers or ex-smokers with a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20].

6. A post-bronchodilator FEV1 ≥ 30 % and ≤ 70% of the predicted normal value and apost-bronchodilator FEV1/FVC ratio < 0.7 at screening.

7. Evidence of pre-bronchodilator hyperinflation (RV>120% predicted) at screening (V1)and baseline (V2).

8. Subject is willing and, in the opinion of the Investigator, able to change currentCOPD therapy as required by the protocol.

9. Subject is treated with double or triple therapy for at least 1 month prior toscreening visit with either:

10. Inhaled corticosteroids/long-acting β2-agonist, combination treatment (fixedand/or free)

11. Inhaled corticosteroids and long-acting muscarinic antagonist

12. inhaled corticosteroids/long-acting β2-agonist/long-acting muscarinic antagonist,combination treatment (fixed and/or free) In addition to the above subjects maybe currently taking inhaled short acting β2-agonists and/or inhaled short actinganticholinergics.

13. A cooperative attitude and ability to be trained to correctly use the pMDI inhaler.

14. Compliance with inhaled Beclometasone run-in medication of between 80 to 120% at Visit 2 (baseline visit) and Visit 3 (Treatment Period 1, Day 1)

Exclusion Criteria:

1. Inability to comply with study procedures, required restrictions, study treatmentintake or any other reason that the Investigator considers makes the patientunsuitable to participate.

2. COPD exacerbation requiring oral steroids and/or antibiotics, in the 8 weeks prior toscreening or prior to randomisation.

3. Use of antibiotics for a respiratory tract infection in the 8 weeks prior to screeningor prior to randomisation.

4. Inability to perform technically acceptable impulse oscillometry, whole bodyplethysmography or spirometry at screening, (V1) or baseline (V2).

5. Pregnant, lactating or breastfeeding women at screening, baseline or prior torandomisation. Positive urine pregnancy test at screening, baseline or prior torandomisation.

6. A history of one or more hospitalisations for COPD in the 12 months prior to screeningor prior to randomisation.

7. Requires oxygen therapy, even on an occasional basis.

8. Known respiratory disorders other than COPD which may impact the efficacy or thesafety of the study drug according to investigator's judgement. This can include butis not limited to known alpha-1 antitrypsin deficiency, active tuberculosis, lungcancer and bronchial carcinoma, bronchiectasis, sarcoidosis, lung fibrosis, pulmonaryhypertension and interstitial lung disease.

9. An abnormal and clinically significant 12-lead ECG which may impact the safety of thepatient according to investigator's judgement. N.B: Subject whose electrocardiogram (ECG) (12 lead) shows QTcF>450 males or QTcF> 470ms for females at screening are not eligible.

10. Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neckobstruction that in the opinion of the investigator would prevent use ofanticholinergic agents.

11. History of hypersensitivity to anticholinergics, β2-agonist, corticosteroids or any ofthe excipients contained in any of the formulations used in the trial which may raisecontra-indications or impact the efficacy of the study drug according to theinvestigator's judgement.

12. Clinically significant laboratory abnormalities at screening indicating a significantor unstable concomitant disease which may impact the efficacy of the study drug or thesafety of the patient, according to investigator's judgement.

13. Subjects with a history of chronic uncontrolled disease including, but not limited to,endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal,haematological, urological, immunological, or ophthalmic diseases that theInvestigator believes are clinically significant.

14. Uncontrolled cardiovascular disease: arrhythmias, angina, recent or suspectedmyocardial infarction, congestive heart failure, a history of unstable, oruncontrolled hypertension, or has been diagnosed with hypertension in the 3 monthsprior to screening or randomisation.

15. History of alcohol abuse and/or substance/drug abuse within 2 years prior to screeningvisit.

16. Has had major surgery, (requiring general anaesthesia) in the 8 weeks prior toscreening or prior to randomisation, or has planned surgery through the end of thestudy.

17. Previous lung resection or lung reduction surgery.

18. Participation in another clinical trial and received investigational drug within 30days (or 5 half-lives whichever is longer). N.B.: For biologic products with slowelimination a washout of at least 6 months needs to be met prior to screening visit.