AMPLIFY - D6571C00001 Duaklir USA Phase III Study

Study identifier:D6571C00001

ClinicalTrials.gov identifier:NCT02796677

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 24 week treatment, multicenter, randomized, double blinded, double dummy, parallel-group, clinical trial evaluating the efficacy and safety of aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed-dose combination BID compared with each monotherapy (aclidinium bromide 400 μg BID and formoterol fumarate 12 μg BID) and tiotropium 18 μg QD when administered to patients with stable chronic obstructive pulmonary disease.

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

Study drug

Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg), Aclidinium bromide 400 μg (AB 400 μg), Formoterol fumarate 12 μg (FF 12 μg), Tiotropium 18 μg (TIO 18 μg)

Sex

All

Actual Enrollment

1595

Study type

Interventional

Age

40 Years - 130 Years

Date

Study Start Date: 05 Jul 2016

Primary Completion Date: 08 Jun 2017

Study Completion Date: 08 Jun 2017

Study design

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

Verification:

Verified 01 Nov 2018 by AstraZeneca

Collaborators

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
Experimental: AB/FF 400/12 μg BID Participants were administered AB/FF 400/12 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment.	Drug: Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) Inhalation powder Other Name: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler) Other: Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg Inhalation powder Other Name: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler)
Experimental: AB 400 μg BID Participants were administered AB 400 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment.	Drug: Aclidinium bromide 400 μg (AB 400 μg) Inhalation powder Other Name: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler) Other: Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg Inhalation powder Other Name: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler)
Experimental: FF 12 μg BID Participants were administered FF 12 μg via Pressair®/Genuair® inhaler twice daily for 24 weeks of treatment.	Drug: Formoterol fumarate 12 μg (FF 12 μg) Inhalation powder Other Name: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler) Other: Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg Inhalation powder Other Name: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler)
Experimental: TIO 18 μg QD Participants were administered TIO 18 μg via Handihaler® inhale once daily for 24 weeks of treatment.	Drug: Tiotropium 18 μg (TIO 18 μg) Powder in capsules for oral inhalation Other Name: Oral Inhalation (by Handihaler® Dry Powder Inhaler, DPI) Other: Placebo to TIO 18 μg Powder in capsules for oral inhalation Other Name: Oral Inhalation (by Handihaler® Dry Powder Inhaler, DPI)

Documents available

Protocol
Download
SAP
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Sanjay Sethi

3495 Bailey Ave , Buffalo NY14215, USA