Clincosm LogoSign in Get a demo

AVANT: Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT03022097
Collaborator
Parexel (Industry)
1,067
Enrollment
75
Locations
4
Arms
62.6
Actual Duration (Months)
14.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Aclidinium bromide/formoterol Fixed-Dose Combination
  • Drug: Aclidinium bromide
  • Drug: Formoterol Fumarate
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1067 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Jan 24, 2017
Actual Primary Completion Date :
Apr 14, 2022
Actual Study Completion Date :
Apr 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental 1

Aclidinium bromide 400μg/Formoterol fumarate 12 μg

Drug: Aclidinium bromide/formoterol Fixed-Dose Combination
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair
Experimental: Experimental 2

Aclidinium bromide 400 μg

Drug: Aclidinium bromide
Inhaled Aclidinium bromide 400 μg, twice per day via Genuair
Active Comparator: Comparator

Formoterol fumarate 12 μg

Drug: Formoterol Fumarate
Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in 1-hour morning post-dose dose Forced expiratory volume in 1 second (FEV1) [Week 24]

    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.

  2. Change from baseline in morning pre-dose (trough) FEV1 [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.

  3. Change from baseline in trough FEV1 [Week 24]

    Change from baseline in trough FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24.

Secondary Outcome Measures

  1. Change from baseline in peak FEV1 [Week 24]

    Change from baseline in peak FEV1 of Aclidinium bromide 400 μg compared to placebo at week 24

  2. Improvements Transition Dyspnoea Index (TDI) focal score [Week 24]

    Improvements TDI focal score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24

  3. Change from baseline in St Georges Respiratory Questionnaire (SGRQ) total score [Week 24]

    Change from baseline in SGRQ total score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 130 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Adult male or non-pregnant, non-lactating female patients aged ≥40
    1. Patients with a diagnosis of COPD prior to Visit 1 (screening)
    1. Patients with moderate to severe stable COPD (Stage II or Stage III) at Visit 1: post-bronchodilator FEV1 ≥30% and < 80% and post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%
    1. Current or former smokers with a smoking history of ≥ 10 pack-years
    1. 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)
    1. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent
Exclusion Criteria:
    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.
    1. Previous enrolment or randomisation in the present study
    1. History or current diagnosis of asthma
    1. 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
    1. 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
    1. Clinically significant respiratory conditions other than COPD
    1. 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
    1. Use of long-term oxygen therapy (≥15 hours/day)
    1. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
    1. Clinically significant cardiovascular conditions
    1. Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
    1. Patients with QT corrected interval (QTc) using Fridericia formula (QTcF) (QTc=QT/ Duration in milliseconds between two R peaks of two consecutive QRS complexes (RR1/3)

470 msec as indicated in the centralised reading report assessed at Screening (Visit 1)

    1. Patients with clinically significant abnormalities in the clinical laboratory tests, ECG parameters (other than QTcF) or in the physical examination at Visit 1 (screening)
    1. Patients with abnormal liver function tests defined as Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or total bilirubin ≥ 2.5 times upper limit of normal ranges at screening
    1. Patient with known non-controlled history of infection with human immunodeficiency virus and/or active hepatitis
    1. Patient with a history of hypersensitivity reaction to inhaled anticholinergic drugs, sympathomimetic amines, inhaled medication or any component thereof
    1. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
    1. 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
    1. Any other serious or uncontrolled physical or mental dysfunction
    1. 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
    1. Patients unlikely to be cooperative or cannot comply with the study procedures
    1. Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to screening
    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
    1. Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients
    1. Any other conditions that, in the Investigator's opinion, might have indicated the patient to be unsuitable for the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Anhui China 230061
2 Research Site Baotou China 14010
3 Research Site Beijing China 100050
4 Research Site Beijing China 100097
5 Research Site Beijing China CN-100083
6 Research Site Beijing China
7 Research Site Cangzhou China 61000
8 Research Site Changchun China 130021
9 Research Site Changsha China 410005
10 Research Site Changsha China 430033
11 Research Site Chengdu China 610072
12 Research Site Guangzhou China 510530
13 Research Site Haikou China 570311
14 Research Site Hangzhou China 310003
15 Research Site Hangzhou China 310005
16 Research Site Hangzhou China 310014
17 Research Site Hefei China 230001
18 Research Site Hefei China 230022
19 Research Site Hengyang China 50012
20 Research Site Hohhot China 010017
21 Research Site Liangyugang China 222002
22 Research Site Linhai China 317000
23 Research Site Nanchang China 330006
24 Research Site Nanjing China 210009
25 Research Site Qiqihar China 161005
26 Research Site Shanghai China 200030
27 Research Site Shanghai China 200040
28 Research Site Shanghai China 200062
29 Research Site Shanghai China 200090
30 Research Site Shanghai China 200240
31 Research Site Shanghai China 200433
32 Research Site Shanghai China 201200
33 Research Site Shanxi China 30001
34 Research Site Shengyang China 110004
35 Research Site Shenzhen China 518020
36 Research Site Shenzhen China 518053
37 Research Site Shijiazhuang China 050000
38 Research Site Taiyuan China 030001
39 Research Site Tianjin China 300052
40 Research Site Wenzhou China 325015
41 Research Site Wuxi China 214023
42 Research Site Xiamen China 361004
43 Research Site Xian China 710061
44 Research Site Xining China 810007
45 Research Site Yangzhou China 225000
46 Research Site Yanji China 133000
47 Research Site Yinchuan China 750004
48 Research Site Zhanjiang China 524001
49 Research Site Ahmedabad India 380060
50 Research Site Alappuzha India 688524
51 Research Site Ernakulam India 683577
52 Research Site Guntur India 522001
53 Research Site Jaipur India 302006
54 Research Site Kozhikode India 673008
55 Research Site Mysore India 57002
56 Research Site Nagpur India 440010
57 Research Site Nagpur India 440012
58 Research Site Nagpur India 440019
59 Research Site Pune India 411019
60 Research Site Pune India 411057
61 Research Site Pune India 440012
62 Research Site Vijayawada India 520 008
63 Research Site Caloocan City Philippines 1400
64 Research Site Iloilo City Philippines 5000
65 Research Site Manila Philippines 1000
66 Research Site Quezon City Philippines 1000
67 Research Site Quezon City Philippines 1100
68 Research Site Quezon City Philippines 1101
69 Research Site Keelung Taiwan 20448
70 Research Site Taichung Taiwan 40201
71 Research Site Taipei Taiwan 112
72 Research Site Hanoi Vietnam 10000
73 Research Site Ho Chi Minh City Vietnam 700000
74 Research Site Ho Chi Minh City Vietnam 70000
75 Research Site Ho Chi Minh Vietnam 70000

Sponsors and Collaborators

  • AstraZeneca
  • Parexel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT03022097
Other Study ID Numbers:
  • D6570C00002
  • M-AS464-30
First Posted:
Jan 16, 2017
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bromides
Formoterol Fumarate

Study Results

No Results Posted as of May 24, 2022