COPDPhase 3AVANTNCT03022097

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

A Phase 3 study testing Aclidinium bromide/formoterol Fixed-Dose Combination, Aclidinium bromide and Formoterol Fumarate in people with COPD, run by AstraZeneca at 74 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 40 to 130 years
Conditions the study is for: COPD
What is being tested?: Aclidinium bromide/formoterol Fixed-Dose Combination, Aclidinium bromide and Formoterol Fumarate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,625 participants
Where: 74 sitesin 5 countries
Study dates: 2 Feb 2017to 14 Apr 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Adult male or non-pregnant, non-lactating female patients aged ≥40
2. Patients with a diagnosis of COPD prior to Visit 1 (screening)
3. 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%
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

Who cannot join

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

Show all 25Show fewer

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/ 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)
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 Aspartate aminotransferase (AST), Alanine aminotransferase (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
18. 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
19. Any other serious or uncontrolled physical or mental dysfunction
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

Trial locations and contacts

74 sites in 5 countries.

Country

City, postcode or hospital

74 sites in 5 countries

China48 sites

Research Site
Baotou, 14010
Research Site
Beijing, 100050
Research Site
Beijing, 100097
Research Site
Beijing, 102300
Research Site
Beijing, CN-100083
Research Site
Cangzhou, 61000
Research Site
Changchun, 130021
Research Site
Changsha, 410005
Research Site
Changsha, 430033
Research Site
Chengdu, 610072
Research Site
Guangzhou, 510530
Research Site
Haikou, 570311
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310005
Research Site
Hangzhou, 310014
Research Site
Hefei, 230001
Research Site
Hefei, 230022
Research Site
Hefei, 230061
Research Site
Hengyang, 50012
Research Site
Hohhot, 010017
Research Site
Liangyugang, 222002
Research Site
Linhai, 317000
Research Site
Nanchang, 330006
Research Site
Nanjing, 210009
Research Site
Qiqihar, 161005
Research Site
Shanghai, 200030
Research Site
Shanghai, 200040
Research Site
Shanghai, 200062
Research Site
Shanghai, 200090
Research Site
Shanghai, 200240
Research Site
Shanghai, 200433
Research Site
Shanghai, 201200
Research Site
Shanxi, 30001
Research Site
Shengyang, 110004
Research Site
Shenzhen, 518020
Research Site
Shenzhen, 518053
Research Site
Shijiazhuang, 050000
Research Site
Taiyuan, 030001
Research Site
Tianjin, 300050
Research Site
Wenzhou, 325015
Research Site
Wuxi, 214023
Research Site
Xi'an, 710061
Research Site
Xiamen, 361004
Research Site
Xining, 810007
Research Site
Yangzhou, 225000
Research Site
Yanji, 133000
Research Site
Yinchuan, 750004
Research Site
Zhanjiang, 524001

Other trials in China

India14 sites

Research Site
Ahmedabad, 380060
Research Site
Alappuzha, 688524
Research Site
Ernākulam, 683577
Research Site
Guntur, 522001
Research Site
Jaipur, 302006
Research Site
Kozhikode, 673008
Research Site
Mysore, 57002
Research Site
Nagpur, 440010
Research Site
Nagpur, 440012
Research Site
Nagpur, 440019
Research Site
Pune, 411019
Research Site
Pune, 411057
Research Site
Pune, 440012
Research Site
Vijayawada, 520 008

Other trials in India

Philippines6 sites

Research Site
Caloocan, 1400
Research Site
Iloilo City, 5000
Research Site
Manila, 1000
Research Site
Quezon City, 1000
Research Site
Quezon City, 1100
Research Site
Quezon City, 1101

Other trials in Philippines

Taiwan3 sites

Research Site
Keelung, 20448
Research Site
Taichung, 40201
Research Site
Taipei, 112

Other trials in Taiwan

Vietnam3 sites

Research Site
Hanoi, 10000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, 70000

Other trials in Vietnam

About this study

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.

Conditions: COPD
Being tested: Aclidinium bromide/formoterol Fixed-Dose Combination, Aclidinium bromide, Formoterol Fumarate, Placebo
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aclidinium bromide/formoterol Fixed-Dose CombinationDrug
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair
Aclidinium bromideDrug
Inhaled Aclidinium bromide 400 μg, twice per day via Genuair
Formoterol FumarateDrug
Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler
PlaceboDrug
Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler

Study groups in NCT03022097
Study group	Role	What they receive
Experimental 1	Experimental	Aclidinium bromide 400μg/Formoterol fumarate 12 μg Receives: Drug: Aclidinium bromide/formoterol Fixed-Dose Combination
Experimental 2	Experimental	Aclidinium bromide 400 μg Receives: Drug: Aclidinium bromide
Comparator	Active comparator	Formoterol fumarate 12 μg Receives: Drug: Formoterol Fumarate
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in 1-hour Morning Post Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in 1-hour morning post-dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24.
Baseline was defined as the average of the two FEV1 values measure prior to the administration of the first dose of the IP at randomisation visit. If one of the two values was missing, the available one was used as baseline. If both values were missing, the screening pre-bronchodilator value was used.
Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Measured: Week 24, 1-hour morning post-dose
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide/Formoterol Fumarate
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate 12 μg at Week 24.
Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value.
Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Measured: Week 24, morning pre-dose (trough)
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24.
Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value.
Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Measured: Week 24, morning pre-dose (trough)

Secondary outcomes (3)

Change From Baseline in Peak FEV1
Change from baseline in peak FEV1 of Aclidinium bromide 400 μg compared to placebo at week 24.
Peak FEV1 was the highest value recorded at Week 24 after morning IP intake.
Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Measured: Week 24, peak
Improvements Transition Dyspnoea Index (TDI) Focal Score
Improvements TDI focal score of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and Aclidinium bromide 400μg compared to placebo at week 24.
Transition Dyspnoea Index (TDI) measures severity of breathlessness in symptomatic patients. An impairment severity score is assigned for three components: functional impairment; magnitude of task and magnitude of effort. Focal scores is derived as the sum of individual component scores. TDI focal score ranges from -9 to +9, with negative values indicating a worsening in dyspnoea, 0 showing no change from baseline and positive values associated with a post-baseline improvement.
Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Measured: Week 24
Change From Baseline in St Georges Respiratory Questionnaire (SGRQ) Total Score
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.
St. George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life and perceived well-being. It is composed of 50 items split into 17 parts, from which 3 dimension scores on Symptoms, Activity and Impact are derived. A total score utilising responses to all items can also be derived to assess the overall impact of COPD on quality of life. SGRQ dimension and total scores range from 0 to 100, with higher scores indicating a worse possible health status.
Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 201714 Apr 2022

First posted16 Jan 2017 (estimated)
Study start2 Feb 2017
Primary completion14 Apr 2022
Study completion14 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,625 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03022097
Sponsor's protocol ID: D6570C00002
Other IDs: M-AS464-30
Acronym: AVANT
Status last verified: Mar 2025
First submitted: 13 Jan 2017
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03022097
Acronym / sponsor ID: AVANT / D6570C00002
Conditions: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,625 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 2 Feb 2017 (actual)
Primary completion: 14 Apr 2022 (actual)
Study completion: 14 Apr 2022 (actual)
First posted: 16 Jan 2017 (estimated)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Experimental 1	Experimental	Drug: Aclidinium bromide/formoterol Fixed-Dose CombinationAclidinium bromide 400μg/Formoterol fumarate 12 μg
Experimental 2	Experimental	Drug: Aclidinium bromideAclidinium bromide 400 μg
Comparator	Active comparator	Drug: Formoterol FumarateFormoterol fumarate 12 μg
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 40 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

1. Adult male or non-pregnant, non-lactating female patients aged ≥40
2. Patients with a diagnosis of COPD prior to Visit 1 (screening)
3. 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%
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)

Key exclusion criteria (25 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aclidinium bromide/formoterol Fixed-Dose CombinationInhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair	Drug	Experimental 1
Aclidinium bromideInhaled Aclidinium bromide 400 μg, twice per day via Genuair	Drug	Experimental 2
Formoterol FumarateInhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler	Drug	Comparator
PlaceboInhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler	Drug	Placebo

Primary outcome

Change From Baseline in 1-hour Morning Post Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Week 24, 1-hour morning post-dose
Change from baseline in 1-hour morning post-dose FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Aclidinium bromide at Week 24. Baseline was defined as the average of the two FEV1 values measure prior to the administration of the first dose of the IP at randomisation visit. If one of the two values was missing, the available one was used as baseline. If both values were missing, the screening pre-bronchodilator value was used. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide/Formoterol Fumarate
Time frame: Week 24, morning pre-dose (trough)
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg/Formoterol fumarate 12 μg compared to Formoterol fumarate 12 μg at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.
Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide
Time frame: Week 24, morning pre-dose (trough)
Change from baseline in morning pre-dose (trough) FEV1 of Aclidinium bromide 400 μg compared to placebo at Week 24. Morning pre-dose (trough) FEV1 was defined as the average of the two FEV1 values at morning pre-dose of IP at Week 24. If one value was missing, the remaining was used as the trough value. Estimand is based on the while on-treatment approach, where treatment estimates are analysed while subjects are taking IP.

3 secondary outcomes

Change From Baseline in Peak FEV1
Time frame: Week 24, peak
Improvements Transition Dyspnoea Index (TDI) Focal Score
Time frame: Week 24
Change From Baseline in St Georges Respiratory Questionnaire (SGRQ) Total Score
Time frame: Week 24

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AB/FF 400/12 μg	265	244
AB 400 μg	267	248
FF 12 μg	265	233
Placebo	269	235

Primary outcome: Change From Baseline in 1-hour Morning Post Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Week 24, 1-hour morning post-dose. Least squares mean (Standard Error). Unit: Litres

Measure	AB/FF 400/12 μg n = 262	AB 400 μg n = 265	FF 12 μg n = 259	Placebo n = 267
Value	0.248 (0.013)	0.156 (0.013)	0.138 (0.013)	-0.050 (0.013)

AB/FF 400/12 μg vs AB 400 μg: Least squares mean difference: 0.092 (95% CI 0.060 to 0.124), p <0.001, Mixed Models Analysis

Population analysed: Intention-to-Treat (ITT) population: All randomised participants who took at least one dose of IP and have a baseline FEV1 measurement.

Primary outcome: Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide/Formoterol Fumarate

Time frame: Week 24, morning pre-dose (trough). Least squares mean (Standard Error). Unit: Litres

Measure	AB/FF 400/12 μg n = 262	AB 400 μg n = 265	FF 12 μg n = 259	Placebo n = 267
Value	0.081 (0.014)	0.050 (0.014)	-0.004 (0.014)	-0.084 (0.014)

AB/FF 400/12 μg vs FF 12 μg: Least squares mean difference: 0.085 (95% CI 0.053 to 0.117), p <0.001, Mixed Models Analysis

Population analysed: Intention-to-Treat (ITT) population: All randomised participants who took at least one dose of IP and have a baseline FEV1 measurement.

Primary outcome: Change From Baseline in Morning Pre-dose (Trough) FEV1 for Aclidinium Bromide

Time frame: Week 24, morning pre-dose (trough). Least squares mean (Standard Error). Unit: Litres

Measure	AB/FF 400/12 μg n = 262	AB 400 μg n = 265	FF 12 μg n = 259	Placebo n = 267
Value	0.081 (0.014)	0.050 (0.014)	-0.004 (0.014)	-0.084 (0.014)

AB 400 μg vs Placebo: Least squares mean difference: 0.134 (95% CI 0.103 to 0.166), p <0.001, Mixed Models Analysis

Population analysed: Intention-to-Treat (ITT) population: All randomised participants who took at least one dose of IP and have a baseline FEV1 measurement.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of signature of informed consent throughout the treatment period and including the follow-up period (2 weeks after last IP dose), on average 26 weeks. Only treatment-emergent AEs are reported in the tables below.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AB/FF 400/12 μg	19 of 263 (7.2%)	53 of 263 (20.2%)	0 of 263
AB 400 μg	21 of 266 (7.9%)	44 of 266 (16.5%)	0 of 266
FF 12 μg	26 of 264 (9.8%)	54 of 264 (20.5%)	1 of 264
Placebo	21 of 269 (7.8%)	55 of 269 (20.4%)	2 of 269

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

74 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium bromide/formoterol Fixed-Dose Combination, Aclidinium bromide and Formoterol Fumarate in people with COPD, run by AstraZeneca at 74 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in China, India, Philippines, Taiwan, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 1-hour Morning Post Forced Expiratory Volume in 1 Second (FEV1) (time frame: Week 24, 1-hour morning post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03022097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.