Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
With
Parexel
Age
40–130
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1\. Adult male or non-pregnant, non-lactating female patients aged ≥40
2\. Patients with a diagnosis of COPD prior to Visit 1 (screening)
3\. Patients with moderate to severe stable COPD (Stage II or Stage III) at Visit 1: post-bronchodilator FEV1 ≥30% and \< 80% and post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%
4\. Current or former smokers with a smoking history of ≥ 10 pack-years
5\. Patients able to perform repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria at Visit 1(screening)
6\. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent
You may not be if
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.
2\. Previous enrolment or randomisation in the present study
3\. History or current diagnosis of asthma
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 COPD exacerbation (an emergency room visit for longer than 24 hours will be considered a hospitalization) within 3 months prior to screening and during the run-in period
6\. Clinically significant respiratory conditions other than COPD
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\. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
11\. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
12\. Patients with QT corrected interval (QTc) using Fridericia formula (QTcF) (QTc=QT/ Duration in milliseconds between two R peaks of two consecutive QRS complexes (RR1/3) \>470 msec as indicated in the centralised reading report assessed at Screening (Visit 1)
13\. Patients with clinically significant abnormalities in the clinical laboratory tests, ECG parameters (other than QTcF) or in the physical examination at Visit 1 (screening)
14\. Patients with abnormal liver function tests defined as Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or total bilirubin ≥ 2.5 times upper limit of normal ranges at screening
15\. Patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis
16\. Patient with a history of hypersensitivity reaction to inhaled anticholinergic drugs, sympathomimetic amines, inhaled medication or any component thereof
17\. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
18\. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer
19\. Any other serious or uncontrolled physical or mental dysfunction
20\. Patients with a history (within 2 years prior to Visit 1 (screening) of drug and/or alcohol abuse that may prevent study compliance based on the Investigator judgment
21\. Patients unlikely to be cooperative or cannot comply with the study procedures
22\. Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to screening
23\. Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication
24\. Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients
25\. Any other conditions that, in the Investigator's opinion, might have indicated the patient to be unsuitable for the study
Clareo Health | Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients
