AMPLIFY - D6571C00001 Duaklir USA Phase III Study

• Status: Completed
• Trial end date: 2017-06-08
• Target enrollment: 0
• Participant gender: All

Summary

This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary disease (COPD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bromides; Formoterol Fumarate; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Adult male or non-pregnant, non-lactating female patients aged ≥40.

• Patients with diagnosis of moderate to very severe stable COPD: post-bronchodilator FEV1 < 80% of the predicted normal and post-bronchodilator FEV1/FVC < 70% at Screening Visit.

• Symptomatic patients with a CAT score ≥10 at Screening and Randomization visit (Visits 1 and 2).

• Current or former-smokers, with a smoking history of ≥ 10 pack-years.

• Patients able to perform acceptable and repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria at Visit 1.

• Patients eligible and able to participate in the study and who had signed an Informed Consent Form prior to initiation of any study-related procedures.

Exclusion Criteria:

• 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 D6571C00001.

• Patients with predominant asthma.

• 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.

• 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.

• 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 Screening.

• 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 centralised reading report assessed at Screening.

• Patients with clinically significant abnormalities in the laboratory tests, ECG parameters (other than QTc) or in the physical examination at Screening Visit that might comprise patient safety.

• Patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis.

• Patient with a history of hypersensitivity reaction to inhaled medication or any component thereof, including paradoxical bronchospasm.

• Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention or symptomatic non-stable 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 that cannot comply with the study procedures.

• Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening.

• 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. Patients who demonstrate < 80% compliance with the electronic diary during the run-in period.