Formoterol dose ranging study (ACHIEVE Duaklir USA Phase IIb)

Exclusion Criteria

• • Patients with asthma.
• • Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to Visit 1 or during the run-in period.
• • Patients hospitalized for a COPD exacerbation (an emergency room visit for longer than 24 hours is considered a hospitalization) within 3 months prior to Visit 1.
• • Clinically significant respiratory conditions other than COPD.
• • 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 Visit 1.
• • Use of long-term oxygen therapy (≥ 15 hours/day).
• • Patients who do not maintain regular day/night, waking/sleeping cycles including night shift workers.
• • Clinically significant cardiovascular conditions.
• • Patients with uncontrolled Type I or Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled hypertension.
• • Patients with history of long QT syndrome or whose QTc (calculated according to Fridericia’s Formula QTc=QT/RR1/3) > 470 ms as indicated in the centralized reading report assessed at Visit 1.
• • Patients with clinically significant abnormalities in the laboratory tests, ECG parameters (other than QTc) or in the physical examination at Visit 1 that might compromise patient safety.
• • Patients with a history of hypersensitivity reaction to an inhaled medication or any component thereof, including paradoxical bronchospasm.
• • Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention or symptomatic unstable prostate hypertrophy.
• • 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.
• • Patients with any other serious or uncontrolled physical or mental dysfunction.
• • Patients with a history (within 2 years prior to screening) of drug and/or alcohol abuse that may prevent study compliance based on the Investigator judgment.
• • Patients unlikely to be cooperative or who cannot comply with the study procedures.
• • Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1.
• • 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.
• • Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients.
• • Any other conditions that, in the investigator’s opinion, might render the patient to be unsuitable for the study.
• • 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.
• • Previous randomization in the present study D6571C00002.