Chronic Obstructive Pulmonary Disorder MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Aclidinium bromide/Formoterol Fumarate 400/12 µg fixed-dose combination
Product Code: LAS40464
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Aclidinium bromide
CAS Number:
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 are allowed to enter the trial if they show to have a negative serum pregnancy test at the Screening Visit and are using, during the last 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. (A female is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year post-menopausal or has undergone tubal ligation). 2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years. Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-year history). (Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well). 3. Patient with a clinical diagnosis of stable COPD according to the GOLD Guidelines at the Screening Visit (http://www.goldcopd.org). 4. Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 µg of salbutamol is =65 years) yes F.1.3.1 Number of subjects for this age range 901
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 6 weeks before Screening Visit. 3. Patient hospitalised for COPD exacerbation within 3 months prior to Screening Visit. 4. Clinically significant respiratory conditions defined as: • Known active tuberculosis. • History of interstitial lung or massive pulmonary thromboembolic disease. • Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening Visit. • History of lung transplantation. • Patients who in the investigator’s opinion may need thoracotomy or other lung surgery during the trial. • History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc). • Known a1-antitrypsin deficiency. 6. Use of long-term oxygen therapy (= 15 hours/day). 7. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers (e.g., history of sleep apnoea syndrome, any disease related with sleep disturbances such as restless-legs syndrome or somnambulism). 8. Clinically significant cardiovascular conditions defined as: • Myocardial infarction within the 6 months prior to Screening Visit. • Thoracic surgery within 12 months prior to Screening Visit. • Unstable angina or unstable arrhythmia meaning which has required changes in the pharmacological therapy or other intervention within 12 months prior to Screening Visit, or newly diagnosed arrhythmia within the previous 3 months prior to Screening Visit. • Hospitalisation within 12 months prior to Screening Visit 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. 10. Patient with QTc [calculated according to Bazett formulae (QTc=QT/RR1/2) > 470 msec as indicated in the centralised reading report assessed at Screening Visit. 11. Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG parameters (other than QTc Bazzet) or in the physical examination at the Screening Visit, if the abnormality defines a disease state listed as exclusion criteria, except for those related to COPD. 12. Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm). Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction or acute urinary retention. 13. Patient with symptomatic non-stable prostatic hypertrophy. (However, patients with wellcontrolled, stable, asymptomatic benign prostatic hypertrophy are not excluded). 20. Patient unable to properly use a dry powder (DPI) or pressured metered-dose inhaler (pMDI) inhaler device or to perform spirometry measurements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Co-primary efficacy variables (at Week 24 on treatment): - Change from baseline in morning pre-dose (trough) FEV1 of each aclidinium/formoterol FDC dose compared to formoterol monotherapy 12 µg. - Change from baseline in 1-hour post-morning dose FEV1 of each aclidinium/formoterol FDC dose compared to aclidinium monotherapy 400 µg.;Main Objective: - To assess the long-term bronchodilation of aclidinium/formoterol fixed dose combinations compared to individual components and placebo, when administered twice daily via inhalation to COPD patients. - To assess the benefits of aclidinium/formoterol fixed dose combinations in COPD symptoms, disease-related health status and COPD exacerbations compared to individual components and placebo, when administered twice daily via inhalation to COPD patients. - To evaluate the long-term safety and tolerability of aclidinium/formoterol fixed dose combinations compared to individual components and placebo when administered twice daily via inhalation to COPD patients.;Secondary Objective: N/A;Timepoint(s) of evaluation of this end point: at Week 24 on treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Improvement of TDI focal score of each aclidinium/formoterol FDC dose compared to placebo. - Change from baseline in SGRQ total score of each aclidinium/formoterol FDC dose compared to placebo.;Timepoint(s) of evaluation of this end point: at Week 24 on treatment | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, United Kingdom
Contacts
Public ContactIgnacio Sáez
Almirall S.A.
Outcome results
None listed