Stable moderate to severe Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Sponsors
Laboratorios Almirall, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion and randomisation 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 one medically approved (i.e., mechanical or pharmacological) contraceptive measure. 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. All women of childbearing potential must have a negative pregnancy test at the screening visit. 2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines: (http://www.goldcopd.com) and stable airway obstruction. 3. Patients with a post salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value (i.e., 30% = 100xobserved post-salbutamol FEV1/ predicted FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: For inclusion and randomisation 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 one medically approved (i.e., mechanical or pharmacological) contraceptive measure. 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. All women of childbearing potential must have a negative pregnancy test at the screening visit. 2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines: (http://www.goldcopd.com) and stable airway obstruction. 3. Patients with a post salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value (i.e., 30% = 100xobserved post-salbutamol FEV1/ predicted FEV1 =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 the screening visit. Patients who develop a respiratory tract infection or exacerbation during the screening 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 screening visit. 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 any 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. Patients on a stable pulmonary rehabilitation program prior to entry and anticipated to be stable throughout the study can be enrolled. · Lung cancer 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 for 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 which at the discretion of the investigator could place the patient at higher risk derived from his/her participation in 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 formula (QTc=QT/RR1/2) above 470 milliseconds in any of the ECGs performed at screening visit or at visit 1 (Day -1). 11. Patients who can not perform repeatable spirometry attempts at the screening visit. 12. History of untoward reactions to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm). 13. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry. 14. Clinically relevant abnormalities laboratory, ECG parameters (other than QTc), or physical examination results at the screening evaluation that in the investigator’s opinion, preclude study participation. 15. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication (see section 10.3.2). 16. Patients with a history of drug and/or alcohol ab;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 the screening visit. Patients who develop a respiratory tract infection or exacerbation during the screening 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 screening visit. 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 any 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. Patients on a stable pulmonary rehabilitation program prior to entry and anticipated to be stable throughout the study can be enrolled. · Lung cancer 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 for 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 which at the discretion of the investigator could place the patient at higher risk derived from his/her participation in 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 formula (QTc=QT/RR1/2) above 470 milliseconds in any of the ECGs performed at screening visit or at visit 1 (Day -1). 11. Patients who can not perform repeatable spirometry attempts at the screening visit. 12. History of untoward reactions to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm). 13. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry. 14. Clinically relevant abnormalities laboratory, ECG parameters (other than QTc), or physical examination results at the screening evaluation that in the investigator’s opinion, preclude study participation. 15. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication (see section 10.3.2). 16. Patients with a history of drug and/or alcohol ab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the time of dosing (a.m. or p.m.) at steady state influences the bronchodilator response of aclidinium bromide compared to placebo in patients with moderate to severe COPD.;Secondary Objective: To further evaluate the safety and tolerability of multiple doses of aclidinium bromide in moderate to severe COPD patients.;Primary end point(s): Efficacy variables: Primary efficacy variable: • Change from baseline in the trough FEV1 after 6 days of treatment. Secondary efficacy variables: • Change from baseline in the trough FVC after 6 days of treatment. • Change from baseline in the trough IC after 6 days of treatment. • Change from baseline in the FEV1 and FVC at all time-points after 7 days of treatment in the a.m. regimen and after 6-7 days of treatment in the p.m. regimen. • Change from baseline in the IC at all time-points after 7 days of treatment in the a.m. regimen and after 6-7 days of treatment in the p.m. regimen. • Change from baseline in the peak FEV1 and FVC after 7 days of treatment. • Change from baseline in normalised FEV1 and FVC AUC0-24 after 7 days of treatment in the a.m. regimen and after 6-7 days of treatment in the p.m. regimen. • Change from baseline in normalised FEV1 and FVC AUC0-12 after 7 days of treatment. • Change from baseline in normalised FEV1 and FVC AUC12-24 after 7 days of treatment in the a.m. regimen and after 6 days of treatment in the p.m. regimen. • Use of “as needed” daily rescue medication (number of salbutamol puffs, as recorded by the patient during the treatment period). Safety variables: • Adverse Events (AEs). • Serious Adverse Events (SAEs). • 12-lead ECG parameters. • Blood pressure parameters. • Laboratory parameters (standard haematology, biochemistry and urinalysis). • Physical examination. Other variables: • Use of concomitant medication. • Number (%) of withdrawals and reasons for withdrawal.;Main Objective: To assess whether the time of dosing (a.m. or p.m.) at steady state inf | — |
Countries
Germany, United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed