Moderate to severe chronic obstructive pulmonary disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: Aclidinium bromide 400 µg
Product Code: LAS34273
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Aclidinium bromide
CAS Number: 320345-99-1
Current Sponsor code: LAS34273
Con
Sponsors
Laboratorios Almirall, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-lactating females aged = 40. 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
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 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. 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 during the past 12 months. •History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc). •Post organ 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. Body Mass Index (BMI) = 40. 7. Patients who have participated in an acute pulmonary rehabilitation program within the previous 6 months (NOTE: Patients on a stable pulmonary rehabilitation exercise regimen for at least 6 weeks are not excluded). 8. Clinically significant cardiovascular conditions defined as: •Myocardial infarction during the previous 6 months. •Unstable angina, unstable arrhythmia which has required changes in the pharmacological therapy or other intervention 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) as per the New York Heart Association. 9. Patients with non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis. 10. Patients who have a resting systolic blood pressure = 200 mm Hg, a resting diastolic blood pressure = 120 mm Hg, or a resting heart rate = 105 bpm at Screening Visit (Visit 1) or Visit 2 (pre-randomization). 11. QTc [calculated according to Bazett’s formulae (QTc=QT/RR1/2), as indicated in the paper tracing generated by the equipment used to record the ECGs] above 470 milliseconds in the ECG performed at Screening Visit (Visit 1). 12. Patients with clinically relevant abnormalities in the results of the clinical laboratory tests, in ECG parameters other than QTc, or in the physical examination at the screening evaluation (Visit 1), if the abnormality defines a disease state listed as an exclusion criteria, except for those related to COPD. 13. Patients with a history (within the previous 5 years) of drug and/or alcohol abuse that may prevent compliance with trial activities. 14. 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. 15. Patients with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the long term bronchodilator efficacy of inhaled aclidinium bromide, administered at different dose levels, compared to placebo in COPD patients ;Primary end point(s): Change from baseline in morning pre-dose (trough) Forced Expiratory Volume in one second (FEV1) at week 24 for the E.U. filing and Week 12 for the U.S. filing. For filings outside the U.S. and the E.U., either 24 or 12 weeks will be used depending on the local regulatory guidelines;Secondary Objective: 2. To assess the benefits of aclidinium bromide, administered at different dose levels, compared to placebo, in disease-related health status, COPD symptoms and COPD exacerbations 3. To evaluate the long term safety and tolerability of inhaled aclidinium bromide, administered at different dose levels, compared to placebo in the same target population | — |
Countries
Czech Republic, France, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed