Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb).
This trial has been completed.
|Condition||chronic obstructive pulmonary disease (copd)|
|Treatments||formoterol fumarate (6 μg), formoterol furmarate (20 μg), placebo for formoterol fumarate, formoterol fumarate (12 μg), formoterol fumarate (40 μg)|
|Start date||June 2016|
|End date||December 2016|
|Trial size||228 participants|
|Trial identifier||NCT02796651, D6571C00002|
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).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Glendale, AZ||Research Site||completed|
|Phoenix, AZ||Research Site||completed|
|Tempe, AZ||Research Site||completed|
|Celebration, FL||Research Site||completed|
|Clearwater, FL||Research Site||completed|
|DeLand, FL||Research Site||completed|
|Orlando, FL||Research Site||completed|
|Lawrenceville, GA||Research Site||completed|
|Saint Louis, MO||Research Site||completed|
|Las Vegas, NV||Research Site||completed|
|Charlotte, NC||Research Site||completed|
|Gastonia, NC||Research Site||completed|
|Medford, OR||Research Site||completed|
|Portland, OR||Research Site||completed|
|Easley, SC||Research Site||completed|
|Greenville, SC||Research Site||completed|
|Rock Hill, SC||Research Site||completed|
|Spartanburg, SC||Research Site||completed|
|Boerne, TX||Research Site||completed|
|Killeen, TX||Research Site||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, investigator)|
Change from baseline in normalized FEV1 area under the curve (AUC) over the 12 h period immediately after morning study drug administration, AUC0-12/12h at Day 7 on treatment.
time frame: Day 7
Change from baseline in FEV1 AUC0-6/6h at Day 1 and Day 7 on treatment.
time frame: Day 1 and Day 7
Change from baseline in morning pre-dose (trough) FEV1 at Day 7 on treatment.
time frame: Day 7
Male or female participants from 40 years up to 130 years old.
- 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.
- 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.
|Official title||A Randomized, Double-blind, Placebo-controlled, Incomplete Unbalanced, Crossover Study to Assess the Efficacy and Safety of Three Doses of Formoterol Fumarate in Pressair® Compared With Perforomist® Inhalation Solution (20 and 40 μg Open-label) in Moderate to Severe COPD Patients With Reversible Airway Disease.|
|Principal investigator||Mark H. Gotfried, MD|
|Description||This is a prospective, randomized, double-blind, 5-period incomplete unbalanced crossover, placebo and active comparator (open-label) controlled, multicenter clinical trial to assess the efficacy and safety of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label formoterol fumarate (20 μg BID and 40 μg single dose) administered as an inhalation solution via a standard jet nebulizer (with a mouthpiece) connected to an air compressor (Perforomist® Inhalation Solution). The drug product is an inhalation powder comprising of micronized aclidinium bromide and micronized formoterol fumarate with α-lactose monohydrate as the carrier, presented in a breathactuated device-metered dry-powder inhaler (DPI). It has been approved under the trademarks of Genuair® and/or Pressair® in some territories.|
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