Chronic obstructive pulmonary disease (COPD) MedDRA version: 19.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Duaklir Genuair
Product Name: Aclidinium bromide/Formoterol Fumarate 400/12 µg fixed-dose combination
Product Code: LAS40464
Pharmaceutical
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or non-pregnant, non-lactating female patients aged = 40. Explanatory note: A female is considered to be of childbearing potential unless is at least one year post-menopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). Women of childbearing potential are allowed to enter the trial if they show to have a negative pregnancy test at the Screening Visit and are using, during the last two months before the Screening Visit and during the whole duration of the trial, at least one medically approved and highly effective method of birth control defined as those, alone or in combination, which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly. Male participants are not requested to use contraception methods during their participation on the trial. 2. Patients with diagnosis of moderate to very severe stable COPD: post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 880
Exclusion criteria
Exclusion criteria: 1. Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff), or patients employed by or relatives of the employees of the site or sponsor. 3. Patients with predominant asthma. Explanatory note: If the investigator in his or her medical judgement determines the prior asthma diagnosis is unrelated to subject current condition (e.g. misdiagnosis, premature diagnosis, or resolution of early onset disease), then the patient is eligible for the study. 4. Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to screening or during the run-in period. 5. Patients hospitalized for a COPD exacerbation (an emergency room visit for longer than 24 hours is considered a hospitalization) within 3 months prior to Screening Visit. 6. Clinically significant respiratory conditions other than COPD. Explanatory note: Clinically significant respiratory conditions defined as: a. Known active tuberculosis. b. History of interstitial lung disease or massive pulmonary thromboembolic disease. c. Pulmonary resection or lung volume reduction surgery. d. History of lung transplantation. e. Patients who in the Investigator’s opinion might need thoracotomy or other lung surgery during the study. f. Bronchiectasis secondary to respiratory diseases other than COPD (e.g. cystic fibrosis, Kartagener’s syndrome, etc.) g. Known a1-antitrypsin deficiency. 7. Patients who in the Investigator’s opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening. 8. Use of long-term oxygen therapy (= 15 hours/day). 9. Patients who do not maintain regular day/night, waking/sleeping cycles including night shift workers. Explanatory note: the use of continuous positive airway pressure (CPAP) is not an exclusion criteria. 10. Clinically significant cardiovascular conditions. Explanatory note: Clinically significant cardiovascular conditions, some examples are: a. Myocardial infarction within the 6 months prior to screening. b. Thoracic surgery within 6 months prior to screening. c. Unstable angina or unstable arrhythmia which had required changes in the pharmacological therapy or other intervention within 6 months prior to screening, or newly diagnosed arrhythmia within the 3 months prior to screening which required the pharmacological therapy or other intervention. d. Hospitalization within 6 months prior to screening 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. e. Presence of an implantable cardioverter-defibrillato (ICD) within the last year prior to Scree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective for EU: To assess the non-inferior bronchodilation of AB 400 µg BID as compared to TIO 18 µg QD in COPD patients. Primary Objectives for USA: To assess the bronchodilatory effect of AB/FF 400/12 µg compared to each individual component when administered twice daily via inhalation to COPD patients. ;Secondary Objective: To further characterize the effect of AB/FF 400/12 µg on bronchodilation and health related quality of life compared to individual components when administered twice daily via inhalation to COPD patients.; Primary end point(s): For EU: Outcome measure and primary comparison - Change from baseline in morning predose (trough) FEV1 at week 24 comparing AB 400 µg versus TIO 18 µg. For USA: Outcome measure and comparison - Change from baseline in 1-hour morning post-dose dose FEV1 of AB/FF 400/12 µg compared to AB 400 µg at week 24. - Change from baseline in morning predose (trough) FEV1 of AB/FF 400/12 µg compared to FF 12 µg at week 24. ;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Outcome measure and primary comparison: - Change from baseline in normalized AUC0-3/3h FEV1 of AB/FF 400/12 µg at week 24 compared to AB 400 µg and FF 12 µg. - Number (%) of patients achieving a clinically meaningful improvement (a decrease of at least 4 units from baseline) with AB/FF 400/12 µg in SGRQ total score at week 24 compared to AB 400 µg and FF 12 µg. ;Timepoint(s) of evaluation of this end point: After 24 weeks on treatment. | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary, Israel, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed