Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Conditions: -J449 Chronic obstructive pulmonary disease, unspecified
Chronic obstructive pulmonary disease, unspecified
J449

Registration Number: PER-107-09

Lead Sponsor: aboratorios Almirall, S.A.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• Males and non-pregnant, non-lactating females aged = 40.
• Patients with a clinical diagnosis of stable moderate to severe COPD, according to the GOLD guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).
• Patients whose FEV1 at Screening Visit measured between 10-15 min post inhalation of 400 µg of salbutamol is = 30% <80% of the predicted normal value (i.e., 100xobserved post-salbutamol FEV1/ predicted FEV1 <80%). 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. 1993).
• Patients must be able to perform repeatible pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visit (Visit 1).
• Current or former cigarette smokers with a smoking history of at least 10 packs-year. 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.
• Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically acceptable method of contraception. Women of childbearing potential must have a negative pregnancy test at Screening (Visit 1) and be using either double-barrier contraception or a barrier method plus a spermicidal agent.
• Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.

Exclusion Criteria

• History or current diagnosis of asthma.
• Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Screening Visit (Visit 1). Patients who develop a respiratory tract infection or exacerbation during the run-in period will be discontinued from the trial before randomisation.
• Patients who have been hospitalised for an acute COPD exacerbation within 3 months prior to Screening Visit.
• Clinically significant respiratory conditions
• Use of long-term oxygen therapy (= 15 hours/day).
• Body Mass Index (BMI) = 40.
• Patients who have participated in an acute pulmonary rehabilitation program within the previous 6 months (NOTE: Patients on a stable pulmonary rehabilitation exercise regimen for at least 6 weeks are not excluded).
• Clinically significant cardiovascular conditions
• Patients with non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
• Patients who have a resting systolic blood pressure = 200 mm Hg, a resting diastolic blood pressure = 120 mm Hg, or a resting heart rate = 105 bpm at Screening Visit (Visit 1) or Visit 2 (pre-randomization).
• QTc [calculated according to Bazett’s formulae (QTc=QT/RR1/2), as indicated in the paper tracing generated by the equipment used to record the ECGs] above 470 milliseconds in the ECG performed at Screening Visit (Visit 1).
• Patients with clinically relevant abnormalities in the results of the clinical laboratory tests, in ECG parameters other than QTc, or in the physical examination at the screening evaluation (Visit 1), if the abnormality defines a disease state listed as an exclusion criteria, except for those related to COPD.
• Patients with a history (within the previous 5 years) of drug and/or alcohol abuse that may prevent compliance with trial activities.
• Patients with any other serious or uncontrolled physical or mental dysfunction that, as judged by the investigator, could place the patient at higher risk derived from his/her participation in the study, could confound the results of the study or is likely to prevent the patient from complying with the requirements of the study or completing the study.
• Patients with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:It is defined as the average FEV1 value of the two major readings evaluated 23 and 24 hours after the morning administration of the investigational medicine.<br>Measure:Change from baseline in FEV1 before the morning dose (valley), at week 24<br>Timepoints:week 24<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Measurement of FEV1 during the study.<br>Measure:Change from baseline in the FEV1 peak in week 24 for the EU registration application and in week 12 for the US registration application.<br>Timepoints:week 24 for the EU registration application and in week 12 for the US registration application.<br>;<br>Outcome name:Measurement of clinical improvement by physical examination of signs and symptoms during the study.<br>Measure:Number (%) of patients who achieve a clinically important improvement (> 1 unit) in the focal score of the TDI at week 24.<br>Timepoints:week 24.<br>;<br>Outcome name:Measurement of clinical improvement by physical examination of signs and symptoms during the study.<br>Measure:Number (%) of patients who achieve a clinically important improvement> 4 units) compared to baseline in the total SGRQ score at week 24.<br>Timepoints:week 24.<br>

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