study to assess efficacy and safety of aclidinium bromide and aclidinium bromide/formoterol fumarate in stabile copd patients

Conditions: COPD

Summary: this is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational phase iii study to determine the efficacy and safety of aclidinium bromide/formoterol fumarate compared with individual components and placebo and aclidinium bromide compared with placebo when administered to patients with stable chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * 1. adult male or non-pregnant, non-lactating female patients aged ≥40 * 2. patients with a diagnosis of copd prior to visit 1 (screening) * 3. patients with moderate to severe stable copd (stage ii or stage iii) at visit 1: post-bronchodilator fev1 ≥30% and \< 80% and post-bronchodilator fev1/forced vital capacity (fvc) \< 70% * 4. current or former smokers with a smoking history of ≥ 10 pack-years * 5. patients able to perform repeatable pulmonary function testing for fev1 according to the american thoracic society (ats)/european respiratory society (ers) 2005 criteria at visit 1(screening) * 6. patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent exclusion criteria: * 1. involvement in the planning and/or conduct of the study (applies to astrazeneca staff and/or site staff) or patients employed by or relatives of the employees of the site or sponsor. * 2. previous enrolment or randomisation in the present study * 3. history or current diagnosis of asthma * 4. any respiratory tract infection (including the upper respiratory tract) or copd exacerbation (including the mild copd exacerbation) within 6 weeks prior to screening or during the run-in period * 5. patients hospitalized for copd exacerbation (an emergency room visit for longer than 24 hours will be considered a hospitalization) within 3 months prior to screening and during the run-in period * 6. clinically significant respiratory conditions other than copd * 7. patients who in the investigator's opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to screening * 8. use of long-term oxygen therapy (≥15 hours/day) * 9. patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers * 10. clinically significant cardiovascular conditions * 11. patients with type i or uncontrolled type ii diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension * 12. patients with qt corrected interval (qtc) using fridericia formula (qtcf) (qtc=qt/ duration in milliseconds between two r peaks of two consecutive qrs complexes (rr1/3) \>470 msec as indicated in the centralised reading report assessed at screening (visit 1) * 13. patients with clinically significant abnormalities in the clinical laboratory tests, ecg parameters (other than qtcf) or in the physical examination at visit 1 (screening) * 14. patients with abnormal liver function tests defined as aspartate aminotransferase (ast), alanine aminotransferase (alt), or total bilirubin ≥ 2.5 times upper limit of normal ranges at screening * 15. patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis * 16. patient with a history of hypersensitivity reaction to inhaled anticholinergic drugs, sympathomimetic amines, inhaled medication or any component thereof * 17. patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy * 18. history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer * 19. any other serious or uncontrolled physical or mental dysfunction * 20. patients with a history (within 2 years prior to visit 1 (screening) of drug and/or alcohol abuse that may prevent study compliance based on the investigator judgment * 21. patients unlikely to be cooperative or cannot comply with the study procedures * 22. patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to screening * 23. patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication * 24. patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients * 25. any other conditions that, in the investigator's opinion, might have indicated the patient to be unsuitable for the study