i

A 24-week Treatment, Randomised, Parallel-group, Double blinded, Double- Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium bromide/Formoterol fumarate compared with Individual Components and Placebo and Aclidinium bromide compared with Placebo when Administered to Patients with Stable Chronic Obstructive Pulmonary Disease

PHRR160310-001189

M-AS464-30/ D6570C00002

2015-CT0239

A 24-week Treatment, Randomised, Parallel-group, Double blinded, Double- Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium bromide/Formoterol fumarate compared with Individual Components and Placebo and Aclidinium bromide compared with Placebo when Administered to Patients with Stable Chronic Obstructive Pulmonary Disease

This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium bromide compared with Placebo when administered to patients with stable Chronic Obstructive Pulmonary Disease (COPD).

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-01-02 7 2017-08-02 2019-11-22

Completed

Institution Classification Region LTO #
AstraZeneca AB Private Business Sweden N/A
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR CDRR-NCR-CRO-4
Institution Region
AstraZeneca AB Sweden
Name E-Mail Institution and Institution Address
Sherry Grimaldo Sherry.Grimaldo@parexel.com 15F Philam Life Tower 8767 Paseo de Roxas, Makati City 1226 Philippines
Name E-Mail Institution and Institution Address
Maaliddin Biruar Maaliddin.Biruar@parexel.com 15th Floor Philam Life Tower, 8767 Paseo de Roxas, Makati City, Philippines
Name Expertise Affiliation
Albert B. Albay, Jr., MD Pulmonologist Manila Doctors Hospital
Araceli Maliwat-Galapon, MD Pulmonologist St. Michael Family Hospital
Joel M. Santiaguel, MD Pulmonologist Quirino Memorial Medical Center
Joven Roque V. Gonong, MD Pulmonologist Lung Center of the Philippines
Lalaine Llamido Mortera, MD Pulmonologist Manila Central University - Filemon D. Tanchoco Medical Foundation
Malbar G. Ferrer, MD Pulmonologist St. Paul University of Iloilo
Manuel Peter Paul C. Jorge II, MD Pulmonologist University of the Philippines - Philippine General Hospital
Marie Grace Dawn T. Isidro, MD Pulmonologist West Visayas State University Medical Center
Ronnie Z. Samoro, MD Pulmonologist HealthLink Iloilo Inc.
Teresita S. de Guia, MD Pulmonologist Philippine Heart Center
Project Location Institutional Ethics Review Board
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
St. Michael Family Hospital N/A
Quirino Memorial Medical Center Quirino Memorial Medical Center Hospital Ethics Committee
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee
Manila Central University - Filemon D. Tanchoco Medical Foundation Manila Central University - Filemon D. Tanchoco Medical Foundation Institutional Review Board
St. Paul University of Iloilo N/A
University of the Philippines - Philippine General Hospital N/A
West Visayas State University Medical Center N/A
HealthLink Iloilo Inc. N/A
Philippine Heart Center Philippine Heart Center Ethics Review Committee

Chronic Obstructive Pulmonary Disease

The primary efficacy variables are the following:
 Change from baseline in 1-hour morning post-dose dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24.
 Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate at Week 24.
 Change from baseline in trough FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24.

Unspecified

Completed

  • China
  • Philippines
  • Taiwan
  • Vietnam

Clinical Trial

M-AS464-30/ D6570C00002

20151015104655, 20151022105819, 20151126100756

2016-02-12

0000-00-00

10

118

Unspecified

2017-01-02

For inclusion in the study subjects should fulfil the following criteria:
1. Adult male or non-pregnant, non-lactating female patients aged ≥40
 Explanatory note: A female is considered to be of childbearing potential unless is at least one year post-menopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). Women of childbearing potential are allowed to enter the trial if they show to have a negative pregnancy test at the Screening Visit and are using, during the last two months before the Screening Visit and during the whole duration of the trial, at least one medically approved and highly effective method of birth control defined as those, alone or in combination, which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly. Male participants are not requested to use contraception methods during thier participation on the trial.
2. Patients with a diagnosis of COPD (GOLD guidelines, 2015) for a period of at least 6 months prior to Visit 1 (screening).
3. Patients with moderate to severe stable COPD (Stage II or Stage III, according to GOLD Guidelines 2015) at Visit 1: post-bronchodilator FEV1 ≥30% and < 80% and post-bronchodilator FEV1/FVC < 70%
4. Current or former smokers with a smoking history of ≥ 10 pack-years.
5. Patients able to perform repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria at Visit 1(screening ).
6. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
1. 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.
2. Previous enrolment or randomisation in the present study
3. History or current diagnosis of asthma.
4. 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.
5. Patients hospitalized for COPD exacerbation (an emergency room visit for longer than 24 hours will be considered a hospitalization) within 3 months prior to screening and during the run-in period.
6. Clinically significant respiratory conditions other than COPD
7. 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.
8. Use of long-term oxygen therapy (≥15 hours/day).
9. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.
10. Clinically significant cardiovascular conditions:
11. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension.
12. Patients with QT corrected interval (QTc) using Fridericia formula (QTcF) (QTc=QT/RR1/3) >470 msec as indicated in the centralised reading report assessed at Screening (Visit 1).
13. Patients with clinically significant abnormalities in the clinical laboratory tests, ECG parameters (other than QTcF) or in the physical examination at Visit 1 (screening).
14. Patients with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 2.5 times upper limit of normal ranges at screening
15. Patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis
16. Patient with a history of hypersensitivity reaction to inhaled anticholinergic drugs, sympathomimetic amines, inhaled medication or any component thereof.
17. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
19. Any other serious or uncontrolled physical or mental dysfunction.
 Explanatory note: as judged by the Investigator, the dysfunction could place the patient at a higher risk as a result of his/her participation in the study, or confound the results of the study, or would be likely to prevent the patient from complying with the requirements of the study or completing the study
20. Patients with a history (within 2 years prior to Visit 1 (screening) of drug and/or alcohol abuse that may prevent study compliance based on the Investigator judgment.
21. Patients unlikely to be cooperative or cannot comply with the study procedures
22. Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to screening.
23. 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.
24. Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients.
25. Any other conditions that, in the Investigator’s opinion, might have indicated the patient to be unsuitable for the study.

Interventional

Aclidinium bromide/Formoterol fumarate

Subjects will be allocated to the four treatment groups in a 1:1:1:1 ratio:
 Aclidinium bromide 400 μg/Formoterol fumarate 12 μg administered via Genuair inhaler
 Aclidinium bromide 400 μg administered via Genuair inhaler
 Formoterol fumarate 12 μg administered via Turbuhaler inhaler
 Placebo

Date Amendment Classification Reason
2016-02-29 Amendments related to the protocol Informed consent
2017-04-03 Amendments related to the protocol Informed consent

Randomized

Double Blind

Unspecified

Parallel

 To assess the bronchodilatory effect of Aclidinium bromide 400 μg /Formoterol fumarate 12 μg compared to individual components and placebo when administered twice daily via inhalation to COPD patients.
 To assess the bronchodilatory effect of Aclidinium bromide 400 μg compared to placebo when administered twice daily via inhalation to COPD patients.

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
©2021 HERDIN PLUS. All rights reserved. | Contact Us | Keep up to date