Twenty-four moderate to severe COPD patients will be included in the study. MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Trade Name: Foradil® Aerolizer® 12 µg inhalation powder, hard capsule
Product Name: Foradil Aerolizer 12mcg inhalation powder, hard capsule
Pharmaceutical Form: Inhalation powder, hard capsule
INN or
Sponsors
Laboratorios Almirall, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult caucasian male and non-pregnant, non-lactating female patients aged between 40 and 80 years, both inclusive, with stable moderate to severe COPD. Women of childbearing potential are allowed to enter the trial ONLY if they use a medically approved (mechanical or pharmacological) contraceptive measure. 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 in serum at screening. 2. Clinical diagnosis of moderate to severe COPD (stages II and III according to the 2006 GOLD classification), in stable conditions (no COPD exacerbation within the previous 6 weeks). 3. Screening FEV1 value of 30 ==65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of clinically significant diseases other than COPD, which may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient’s ability to take part in it. 2. Diagnosis of current or recent (less than 2 years) symptoms of asthma, allergic rhinitis or atopy. 3. Presence of exercise-induced bronchospasm, pulmonary diseases or history of thoracic surgery. 4. Presence of a respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to screening. Patients who develop a respiratory tract infection or exacerbation during the run-in period will be discontinued from the trial prior to randomisation. 5. Hospitalisation for an acute exacerbation in the 3 months prior to screening. 6. Eosinophil count 600 cells / mm3. 7. Evidence of contraindicated use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma. 8. Use of long-term oxygen therapy (= 15 hours/day). 9. Presence of any 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. 10. Presence of any 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. · Arterial hypertension not sufficiently controlled by antihypertensive treatment (RR systolic > 170 mmHg; RR diastolic > 95 mmHg). · Clinically relevant tachycardia (heart rate>100 bpm) or bradycardia (heart rate < 45 bpm). 11. Recent (less than 12 months) stroke. 12. Unstable diabetes mellitus. 13. History of untoward reactions to inhaled anticholinergics, 2-agonists, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm). 14. Intention to use any concomitant medication not permitted by this protocol or insufficient washout period for a particular prohibited medication (see section 10.3). 15. Treatment with ß2-antagonists (including eye drops). 16. Treatment with drugs that may modify QT interval (non-potassium sparing diuretics, MAOIs, TCAs, SSRIs, antipsychotic agents, serotonin receptor agonists, macrolide antibiotics, fluoroquinolone antibiotics, anti-protozoal antibiotics and antihypertensive agents). 17. Loss of more than 400 mL of blood within the previous 3 m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the safety, tolerability and effects on lung function after one single day of therapy (qd or bid) of the above mentioned 4 treatments;Main Objective: To assess, in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients, the pharmacokinetics of: a) Formoterol 12 µg delivered by Foradil® via Aerolizer® (AER), once a day (one puff) for one day. b) Formoterol 12 µg delivered by Foradil® via Aerolizer® (AER), twice a day (one puff twice a day) for one day. c) Formoterol 12 µg delivered by Almirall Inhaler (ALM), once a day (one puff) for one day. d) Fixed Dose Combination (FDC) of formoterol 12 µg + aclidinium bromide 200 µg delivered by Almirall Inhaler (ALM), once a day (one puff) for one day. ;Primary end point(s): - Relative bioavailability of formoterol 12 µg delivered by Almirall Inhaler (ALM) qd versus formoterol 12 µg delivered by Aerolizer (AER) qd. - Relative formoterol bioavailability of 12 µg + aclidinium bromide 200µg ALM qd versus 12 µg ALM qd. - Relative formoterol bioavailability of 12 µg + aclidinium bromide 200µg ALM qd versus 12 µg AER qd. - Relative formoterol bioavailability of 12 µg ALM qd versus 12 µg AER bid. - Relative formoterol bioavailability of 12 µg + aclidinium bromide 200 µg ALM qd versus 12 µg AER bid. | — |
Countries
Germany
Outcome results
None listed