ong-term efficacy and safety of aclidinium/formoterol Fixed-Dose Combinatio

Conditions: Chronic Obstructive Pulmonary Disorder
MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-001524-38-GB

Lead Sponsor: ALMIRALL, S. A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1733

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 < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
5. Patient with a diagnosis of moderate to severe COPD according to the GOLD Guidelines
classification (stages II and III) at the Screening Visit: FEV1 measured between 10-15 minutes
post inhalation of 400 µg of salbutamol is 30% = FEV1 < 80% of the predicted normal value (i.e.,
100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and = 30%).
(Predicted normal values to be used for calculation purposes are to be based on European
Community for Steel and Coal predicted values (Quanjer et al. 199324)).
6. Patient must be able to perform repeatable pulmonary function testing for FEV1 according to
ATS/ERS 2005 criteria at Screening Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 832
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 901

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.