Maintenance treatment of patients with moderate to severe stable chronic obstructive pulmonary disorder. MedDRA version: 8.1 Level: PT Classification code 10009033
Conditions
Interventions
Product Name: Aclidinium Bromide
Product Code: LAS 34273
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Aclidinium Bromide
CAS Number: 320345-99-1
Current Sponsor code: LAS 34273
Concentr
Sponsors
Laboratorios Almirall, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion and randomization in the trial, patients must meet each of the following criteria: 1. Males and non-pregnant, non-lactating females aged = 40. Women of childbearing potential are allowed to enter the trial ONLY if they use TWO medically approved (i.e., mechanical or pharmacological) contraceptive measures. A female is considered to be of childbearing potential unless she has had an hysterectomy, is at least one year post-menopausal or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at Visit 1. 2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines: (http://www.goldcopd.com) and stable airway obstruction. 3. Patients whose FEV1 at Visit 1 measured between 30-45 min post inhalation of 400 µg of salbutamol is =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients randomised into the trial must not present any of the following conditions: 1. History or current diagnosis of asthma, allergic rhinitis or atopy. 2. Eosinophil count > 600 cells/mm3. 3. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks prior to Visit 1. Patients who develop a respiratory tract infection or exacerbation during the run-in period will be discontinued from the trial prior to randomisation. 4. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to Visit 1. 5. Use of long-term oxygen therapy (= 15 hours/day). 6. Clinically significant respiratory conditions defined as: • Known active tuberculosis. • History of interstitial lung or pulmonary thromboembolic disease. • Pulmonary resection during the past 12 months. • History of life-threatening COPD. • History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc). • Patients who in the investigator’s opinion may need pulmonary rehabilitation or a thoracotomy during the trial. 7. Clinically significant cardiovascular conditions defined as: • Myocardial infarction during the last 6 months. • 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. 8. Patients in whom the use of anticholinergic drugs is contraindicated: those with a known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma. 9. Patients with any other serious or uncontrolled physical or mental dysfunction at the discretion of the investigator which could place the patient at higher risk derived from his/her participation into the study, could confound the results of the trial or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period. 10. 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 any of the ECGs performed at Visit 1 or pre-dosing at Visit 2 (Day 1). 11. Patients with a life expectancy of less than 1 year because of disease severity. 12. Patients who do not demonstrate to perform reproducible spirometry attempts at Visit 1 and predosing at Visit 2 (Day 1) as stated in section 11.2.1. 13. History of untoward reactions to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm). 14. Patients unable to properly use a dry powder or pMDI inhaler device or to perform spirometry and peak flow measurements. 15. Clinically relevant abnormalities in the results of laboratory, ECG parameters, other than QTc, or physical examination at the screening evaluation (Visit 1) if the abnormality defines a disease state listed as an exclusion criterion, except for those related to COPD. 16. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout pe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the long term bronchodilator efficacy of LAS 34273 200 µg administered once daily by inhalation (via Novolizer®) for 28 weeks compared to placebo in moderate to severe, stable chronic obstructive pulmonary disease (COPD). 2. To assess the benefit in terms of exacerbation control and disease-related health status and additional outcomes for 52 weeks compared to placebo in the same target population. 3. To evaluate the long term safety and tolerability of LAS 34273 200 µg administered once daily for 52 weeks by inhalation (via Novolizer®) compared to placebo in the same target population.;Secondary Objective: N/A;Primary end point(s): Primary Efficacy Endpoint: Trough forced expiratory volume in one second (FEV1). Trough FEV1 is defined as the mean FEV1 value of the two greatest FEV1 readings measured at 23 and 24 hours after the administration of the investigational medicinal product (IMP). The primary timepoint will be trough FEV1 values at the end of the first 28 weeks of treatment. Secondary efficacy variables: - Time to first moderate to severe COPD exacerbation. - Percentage of patients who achieve at least a 4-unit decrease from baseline in the Saint George’s Respiratory Questionnaire (SGRQ) total score at 52 weeks. Safety Endpoints: • Adverse events (AEs) • Serious adverse events (SAEs) • Physical examination (including blood pressure) • Laboratory assessments (standard haematology, biochemistry and urinalysis) • 12-lead ECG tracing • 3-lead 24-h Holter monitoring (in a subgroup of patients, approximately 20% of the total sample, performed at selected centres) • Number of withdrawals due to AEs • Reasons for withdrawal. | — |
Countries
Austria, Czech Republic, Denmark, Germany, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed