Chronic obstructive pulmonary disease (COPD) MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Almirall S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-lactating females aged = 40, at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception. Women of childbearing potential must have a negative pregnancy test at Screening (Visit -1) and have used it for at least two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal IUDs, sexual abstinence or vasectomy of the partner. 2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the GOLD guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. History or current diagnosis of asthma. 2. Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before the Screening Visit (Visit -1). Patients who develop a respiratory tract infection or exacerbation during the run-in period will be discontinued from the trial before randomisation. 3. Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Screening Visit (Visit -1). 4. Clinically significant respiratory conditions defined as: • Known active tuberculosis. • History of interstitial lung or pulmonary thromboembolic disease. • Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening Visit. • History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc). • History of lung transplantation. • Patients who in the investigator’s opinion may need pulmonary rehabilitation or thoracotomy or other lung surgery during the trial. • Patients with a history of a1-antitrypsin deficiency. 5. Use of long-term oxygen therapy (= 15 hours/day). 6. Patient 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. Clinically significant cardiovascular conditions defined as: • Myocardial infarction during the previous 6 months. • Thoracic surgery within 12 months prior to Screening Visit. • Unstable angina, unstable arrhythmia which has required changes in the pharmacological therapy or other intervention (e.g. use of an automated implantable cardioverterdefibrillator) during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months. • Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) according to the New York Heart Association. 8. Patients with non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis. 9. Patients with clinically relevant abnormalities in the results of the clinical laboratory tests, in ECG parameters, or in the physical examination at the screening evaluation (Visit -1). 10. Patients with a history (within the previous 2 years) of drug and/or alcohol abuse that may prevent compliance with trial activities. 11. Patients with any other serious or uncontrolled physical or mental dysfunction that, as judged by the investigator, could place the patient at higher risk derived from his/her participation in the study, could confound the results of the study or is likely to prevent the patient from complying with the requirements of the study or completing the study. 12. Patients with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm). 13. Patients for whom the use of anticholinergic drugs are contraindicated: • Patients with acute urinary retention, symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma (Note: Patients with well-controlled, stable, asymptomatic benign prostatic hypertrophy are not excluded). 14. Patients unable to properly use a multidose dry powder inhaler or a p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: not applicable;Primary end point(s): Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning IMP administration (AUC0-24 ) after 6 weeks of treatment.;Timepoint(s) of evaluation of this end point: Please refer to point E 5.1;Main Objective: 1. To evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg BID versus placebo in moderate to severe COPD patients 2. To evaluate the night-time bronchodilation of inhaled aclidinium bromide 400 µg BID versus tiotropium bromide in moderate to severe COPD patients 3. To assess the safety and tolerability of inhaled aclidinium bromide 400 µg BID in the same target population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in normalised FEV1 AUC12-24 after 6 weeks of treatment.;Timepoint(s) of evaluation of this end point: Please refer to point E 5.2 | — |
Countries
Czech Republic, Germany, Hungary, Poland
Contacts
Public ContactRosa Segarra-Clinical Trial Manager
Almirall S.A.
Outcome results
None listed