Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease - COPD

In brief

To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).

Key facts

Study ID

NCT02796651

Run by

AstraZeneca

People needed

132

Starts

2016-06-30

Expected to finish

2016-12-07

Last updated by the study team

2018-02-07

Who can join

Age: 40 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or non-pregnant, non-lactating female patients aged ≥40.
• Patients with a diagnosis of COPD (GOLD guidelines, 2016) for a period of at least 6 months prior to Visit 1.
• Patients with moderate to severe stable COPD: post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal and post-bronchodilator FEV1/FVC < 70% at Visit 1.
• Patients with reversible airway obstruction defined as an increase in FEV1 of at least 12% and 200 mL over the baseline value after four inhalations of albuterol sulfate 108 µg via a pMDI at Visit 1.
• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Glendale, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tempe, Arizona, United States
• Research Site — Celebration, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Lawrenceville, Georgia, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Gastonia, North Carolina, United States
• Research Site — Medford, Oregon, United States
• Research Site — Portland, Oregon, United States
• Research Site — Easley, South Carolina, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Rock Hill, South Carolina, United States
• Research Site — Spartanburg, South Carolina, United States
• Research Site — Boerne, Texas, United States
• Research Site — Killeen, Texas, United States

Full record on ClinicalTrials.gov

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