Chronic Obstructive Pulmonary Disease MedDRA version: 16.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Eklira ® Genuair®
Product Name: Aclidinium bromide
Product Code: LAS34273
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: ACLIDINIUM BROMIDE
CAS Number: 320345-99-1
Current Spo
Sponsors
ALMIRALL S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult male or non-pregnant, non-lactating female aged =40. Women of childbearing potential will follow specific study requirements. 2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years. 3. Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. History or current diagnosis of asthma. 2. Patients with known current sleep apnoea. 3. Patients who develop a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit (Visit 1) or during the run-in period. 4. Clinically significant respiratory conditions. 5. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension. 6. 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 Visit. 7. Use of long-term oxygen therapy (15 hours/day). 8. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers. 9. Clinically significant cardiovascular conditions. 10. QTc (calculated according to Fridericia's formulae [QTc=QT/RR1/3]) above 470 milliseconds in the manual ECG reading performed at Screening Visit. 11. Patient with clinically relevant abnormalities in the opinion of the investigator at the Screening Visit (Visit 1) in the results of the clinical laboratory tests, ECG parameters or in the physical examination. 12. Patient with a history of hypersensitivity reaction to inhaled anticholinergics, long and short acting ß2-agonists, sympathomimetic amines, or inhaled medication or any component there of (including report of paradoxical bronchospasm). 13. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy. 14. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis. 15. 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. 16. Patient with any other serious or uncontrolled physical or mental dysfunction, or moderate to severe depression, as confirmed by Beck Depression Inventory (BDI-II) total score >28. 17. Patient with a history (within 2 years prior to the Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment. 18. Patient unlikely to be cooperative or that can't comply with the study procedures. 19. Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to the Screening Visit. 20. Patient who intends to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication. 21. Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the effect of aclidinium bromide vs placebo in improving the trough FEV1, COPD symptoms, sleep quality and physical activity after 3 weeks of treatment in patients with stable moderate and severe COPD. • To assess the safety and tolerability of aclidinium bromide 400 µg administered twice daily in the same target population. ;Secondary Objective: No secondary objectives are defined.;Primary end point(s): There are no primary/secondary endpoints. Variables will be pulmonary function, COPD symptoms (early-morning, night-time, evening symptoms) and sleep endpoints assessed at the same level as exploratory. ;Timepoint(s) of evaluation of this end point: At baseline as well as at all visits, and continous throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are no primary/secondary endpoints. Variables will be pulmonary function, COPD symptoms (early-morning, night-time, evening symptoms) and sleep endpoints assessed at the same level as exploratory. ;Timepoint(s) of evaluation of this end point: During the complete study period from first dosing until follow-up visit. | — |
Countries
Germany
Contacts
Public ContactEPD Berlin Germany
PAREXEL International GmbH
Outcome results
None listed