Formoterol dose ranging study (ACHIEVE Duaklir USA Phase IIb)

Study identifier:D6571C00002

ClinicalTrials.gov identifier:NCT02796651

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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.

Medical condition

Chronic obstructive pulmonary disease - COPD

Phase

Phase 2

Healthy volunteers

Study drug

Formoterol fumarate (6 μg), Formoterol furmarate (20 μg), Placebo for formoterol fumarate, Formoterol fumarate (12 μg), Formoterol fumarate (40 μg)

Sex

All

Actual Enrollment

132

Study type

Interventional

Age

40 Years - 130 Years

Date

Study Start Date: 30 Jun 2016

Primary Completion Date: 07 Dec 2016

Study Completion Date: 07 Dec 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2018 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

• 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.

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.

No locations available

Arms	Assigned Interventions
Experimental: Formoterol 6 μg Participants received formoterol fumarate 6 μg administered via Pressair twice daily (BID).	Drug: Formoterol fumarate (6 μg) Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) Other Name: Formoterol (Pressair®)
Experimental: Formoterol 12 μg Participants received formoterol fumarate 12 μg administered via Pressair BID.	Drug: Formoterol fumarate (12 μg) Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) Other Name: Formoterol (Pressair®)
Experimental: Formoterol 24 μg Participants received formoterol fumarate 24 μg administered via Pressair BID.	Drug: Formoterol fumarate (12 μg) Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) Other Name: Formoterol (Pressair®)
Placebo Comparator: Placebo Participants received placebo to formoterol fumarate administered via Pressair BID.	Drug: Placebo for formoterol fumarate Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) Other Name: Placebo (Pressair®)
Experimental: Formoterol 20 μg Participants received Perforomist inhalation solution and were instructed to take one puff from each of the two Pressair inhalers or to inhale one vial from the Perforomist 20 μg inhalation solution BID for 7 ± 1 consecutive days.	Drug: Formoterol furmarate (20 μg) Oral Inhalation (via a standard jet nebulizer connected to an air compressor. Other Name: Perforomist® Inhalation Solution
Experimental: Formoterol 40 μg Participants received Perforomist 40 μg (2 vials of Performist 20 μg) as a single dose of administration.	Drug: Formoterol fumarate (40 μg) Oral Inhalation (via a standard jet nebulizer connected to an air compressor. Other Name: Perforomist® Inhalation Solution

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Mark H. Gotfried

1112 East McDowell Road, Phoenix, AZ 85006, United States.