CompletedNCT02796677Updated Nov 9, 2018Results posted

AMPLIFY - D6571C00001 Duaklir USA Phase III Study

A Phase 3 interventional study of Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) and Aclidinium bromide 400 μg (AB 400 μg) in Chronic Obstructive Pulmonary Disease, sponsored by AstraZeneca. Completed at 163 sites in 10 countries. Open to participants aged 40 Years to 130 Years. Per ClinicalTrials.gov, last updated 2018-11-09.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,595
Allocation: Randomized
Ages: 40 Years to 130 Years
Sex: All

Study summary

This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary disease (COPD).

Read the detailed description

This study was conducted to assess the bronchodilator efficacy and safety as well as effect on health related quality of life of AB/FF 400/12 μg compared to the individual components (AB 400 μg and FF 12 μg) in COPD patients. The trial duration of 24 weeks allows the assessment of the effect on symptoms improvement of the combined treatments versus individual components as well as the long term bronchodilation comparison between AB 400 μg and TIO 18 μg in minimizing the risk of COPD exacerbations in current or former smokers, aged ≥40 in symptomatic COPD patients.

Conditions studied

Chronic Obstructive Pulmonary Disease

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Keywords

Safety
Efficacy
Aclidinium bromide
Formoterol fumarate
Tiotropium
Bronchodilation
COPD

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 1,595 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 130 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 1,595 participants (actual)

Study arms

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) · Other: Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg
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) · Other: Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg
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) · Other: Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg
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) · Other: Placebo to TIO 18 μg

Interventions

DrugAclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg)
Inhalation powder
Also known as: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler)
DrugAclidinium bromide 400 μg (AB 400 μg)
Inhalation powder
Also known as: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler)
DrugFormoterol fumarate 12 μg (FF 12 μg)
Inhalation powder
Also known as: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler)
OtherPlacebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg
Inhalation powder
Also known as: Oral Inhalation (by Pressair®/Genuair® Dry Powder Inhaler)
DrugTiotropium 18 μg (TIO 18 μg)
Powder in capsules for oral inhalation
Also known as: Oral Inhalation (by Handihaler® Dry Powder Inhaler, DPI)
OtherPlacebo to TIO 18 μg
Powder in capsules for oral inhalation
Also known as: Oral Inhalation (by Handihaler® Dry Powder Inhaler, DPI)

What researchers measure

Primary outcomes

Change From Baseline in 1-hour Morning Post-dose Dose Forced Expiratory Volume in 1 Second (FEV1) of AB/FF 400/12 μg Compared to AB 400 μg at Week 24
To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 at 1 hour post-dose of AB/FF 400/12 µg compared to AB 400 μg after administration of oral inhalation powder BID via DIP to participants with COPD. Baseline was defined as the average of the two FEV1 values measured just prior to the administration of the first dose of investigational product (IP) at randomization Visit. If one of the two was missing, then the available one would be used as baseline value.
Time frame: At baseline 1-hour postdose and Week 24
Change From Baseline in Morning Predose (Trough) FEV1 of AB/FF 400/12 μg Compared to FF 12 μg at Week 24
To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough) of AB/FF 400/12 µg compared to FF 12 μg after administration of oral inhalation powder BID via DPI to participants with COPD. Morning pre-dose (trough) FEV1 was defined as the average of the corresponding -30 minute and 0 minute before the morning study medication at Week 24. If one time-point was missing then the available one would be used as morning pre-dose.
Time frame: At baseline morning predose and Week 24
Change From Baseline in Morning Predose (Trough) FEV1 at Week 24 Comparing AB 400 μg Versus TIO 18 μg to Demonstrate Non-inferiority
To assess the non-inferior bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough)of AB 400 µg compared to TIO 18 μg after administration of oral inhalation powder BID via DPI to participants with COPD.
Time frame: At baseline morning predose and Week 24

Secondary outcomes

Change From Baseline in Normalized Area Under Curve 3hours Post-dose (nAUC0-3/3h) FEV1 of AB/FF 400/12 μg Compared to AB 400 μg and and FF 12 μg at Week 24
To assess the bronchodilatory effect by evaluating the mean changes from baseline in nAUC0-3/3h FEV1 of AB/FF 400/12 µg compared to AB 400 μg and and FF 12 μg after administration of oral inhalation powder BID via DPI to participants with COPD.
Time frame: At Day 1 and Day 169
Responder (Number of Participants) Analysis of St. George's Respiratory Questionnaire (SGRQ) Total Score With AB/FF 400/12 μg Versus AB 400 μg and FF 12 μg.
SGRQ was a A standardized self-completed tool used to measure impaired health and perceived well-being ("quality of life") in respiratory diseases. The questionnaire contained 50 items divided into 3 (symptoms, activity and impacts) dimensions. Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100%, zero score indicating no impairment of life quality. A summary score utilizing responses to all items is the total SGRQ score which also ranges from 0 to 100%. The SGRQ scores are calculated using weights attached to each item of the questionnaire which provides an estimate of the distress associated with the symptoms or state described in each item. Higher scores indicate poorer health. A decrease of at least 4 units in the SGRQ total score has been established as the criterion for minimal meaningful improvement. SGRQ responders will be those with a decrease in SGRQ total score of at least 4 units from baseline.
Time frame: At baseline and Week 24

Results

Posted Nov 9, 2018

Participant flow

Study was conducted on participants with stable chronic obstructive pulmonary disease (COPD), in 11 countries: United States (US), Germany, Poland, Hungary, Bulgaria, Ukraine, United Kingdom (UK), Czech Republic, Spain, Israel \& Russia (was not finally started). First participant enrolled was 05 July 2016 \& participant last visit was 08 June 2017

Participant flow — Overall Study
Milestone	Aclidinium Bromide (AB)/Formoterol Fumarate (FF) 400/12 μg	AB 400 μg	FF 12 μg	Tiotropium (TIO) 18 μg
Started	317	478	320	479
Completed treatment and follow-up	279	405	267	403
Completed	279	405	267	405
Not completed	38	73	53	74
Withdrew: Adverse event	11	22	14	14
Withdrew: Protocol violation	7	5	4	8
Withdrew: Lost to follow-up	1	5	2	2
Withdrew: Lack of efficacy	7	9	14	20
Withdrew: Withdrawal by subject	4	14	6	7
Withdrew: Progressive disease	6	15	13	18
Withdrew: Reason not mentioned	2	3	0	5

Outcome measures

PrimaryChange From Baseline in 1-hour Morning Post-dose Dose Forced Expiratory Volume in 1 Second (FEV1) of AB/FF 400/12 μg Compared to AB 400 μg at Week 24

To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 at 1 hour post-dose of AB/FF 400/12 µg compared to AB 400 μg after administration of oral inhalation powder BID via DIP to participants with COPD. Baseline was defined as the average of the two FEV1 values measured just prior to the administration of the first dose of investigational product (IP) at randomization Visit. If one of the two was missing, then the available one would be used as baseline value.

Time frame:: At baseline 1-hour postdose and Week 24
Reported as:: Least squares mean · Litres

Change From Baseline in 1-hour Morning Post-dose Dose Forced Expiratory Volume in 1 Second (FEV1) of AB/FF 400/12 μg Compared to AB 400 μg at Week 24
Litres	AB/FF 400/12 μg	AB 400 μg	FF 12 μg	TIO 18 μg
Change From Baseline in 1-hour Morning Post-dose Dose Forced Expiratory Volume in 1 Second (FEV1) of AB/FF 400/12 μg Compared to AB 400 μg at Week 24	0.253 ± 0.013	0.169 ± 0.011	0.168 ± 0.013	0.161 ± 0.011

Statistical analysis

AB/FF 400/12 μg vs AB 400 μg · Mixed model for repeated measures · p = <0.0001 · Ls mean difference: 0.084 · 95% CI 0.051 to 0.117

PrimaryChange From Baseline in Morning Predose (Trough) FEV1 of AB/FF 400/12 μg Compared to FF 12 μg at Week 24

To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough) of AB/FF 400/12 µg compared to FF 12 μg after administration of oral inhalation powder BID via DPI to participants with COPD. Morning pre-dose (trough) FEV1 was defined as the average of the corresponding -30 minute and 0 minute before the morning study medication at Week 24. If one time-point was missing then the available one would be used as morning pre-dose.

Time frame:: At baseline morning predose and Week 24
Reported as:: Least squares mean · Litres

Change From Baseline in Morning Predose (Trough) FEV1 of AB/FF 400/12 μg Compared to FF 12 μg at Week 24
Litres	AB/FF 400/12 μg	AB 400 μg	FF 12 μg	TIO 18 μg
Change From Baseline in Morning Predose (Trough) FEV1 of AB/FF 400/12 μg Compared to FF 12 μg at Week 24	0.080 ± 0.014	0.066 ± 0.012	0.025 ± 0.014	0.060 ± 0.012

Statistical analysis

AB/FF 400/12 μg vs FF 12 μg · Mixed model for repeated measures · p = 0.0009 · Ls mean difference: 0.055 · 95% CI 0.023 to 0.088

PrimaryChange From Baseline in Morning Predose (Trough) FEV1 at Week 24 Comparing AB 400 μg Versus TIO 18 μg to Demonstrate Non-inferiority

To assess the non-inferior bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough)of AB 400 µg compared to TIO 18 μg after administration of oral inhalation powder BID via DPI to participants with COPD.

Time frame:: At baseline morning predose and Week 24
Reported as:: Least squares mean · Litres

Change From Baseline in Morning Predose (Trough) FEV1 at Week 24 Comparing AB 400 μg Versus TIO 18 μg to Demonstrate Non-inferiority
Litres	AB 400 μg	TIO 18 μg
Change From Baseline in Morning Predose (Trough) FEV1 at Week 24 Comparing AB 400 μg Versus TIO 18 μg to Demonstrate Non-inferiority	0.064 ± 0.013	0.057 ± 0.013

Statistical analysis

AB 400 μg vs TIO 18 μg · Mixed model for repeated measures · p = 0.6377 · Ls mean difference: 0.007 · 95% CI -0.021 to 0.035

SecondaryChange From Baseline in Normalized Area Under Curve 3hours Post-dose (nAUC0-3/3h) FEV1 of AB/FF 400/12 μg Compared to AB 400 μg and and FF 12 μg at Week 24

To assess the bronchodilatory effect by evaluating the mean changes from baseline in nAUC0-3/3h FEV1 of AB/FF 400/12 µg compared to AB 400 μg and and FF 12 μg after administration of oral inhalation powder BID via DPI to participants with COPD.

Time frame:: At Day 1 and Day 169
Reported as:: Least squares mean · Litres

Change From Baseline in Normalized Area Under Curve 3hours Post-dose (nAUC0-3/3h) FEV1 of AB/FF 400/12 μg Compared to AB 400 μg and and FF 12 μg at Week 24
Litres	AB/FF 400/12 μg	AB 400 μg	FF 12 μg	TIO 18 μg
Change From Baseline in Normalized Area Under Curve 3hours Post-dose (nAUC0-3/3h) FEV1 of AB/FF 400/12 μg Compared to AB 400 μg and and FF 12 μg at Week 24	0.237 ± 0.013	0.162 ± 0.010	0.149 ± 0.013	0.151 ± 0.010

Statistical analysis

AB/FF 400/12 μg vs AB 400 μg · Mixed model for repeated measures · p = <0.0001 · Ls mean difference: 0.075 · 95% CI 0.043 to 0.107
AB/FF 400/12 μg vs FF 12 μg · Mixed model for repeated measures · p = <0.0001 · Ls mean difference: 0.087 · 95% CI 0.052 to 0.122

SecondaryResponder (Number of Participants) Analysis of St. George's Respiratory Questionnaire (SGRQ) Total Score With AB/FF 400/12 μg Versus AB 400 μg and FF 12 μg.

SGRQ was a A standardized self-completed tool used to measure impaired health and perceived well-being ("quality of life") in respiratory diseases. The questionnaire contained 50 items divided into 3 (symptoms, activity and impacts) dimensions. Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100%, zero score indicating no impairment of life quality. A summary score utilizing responses to all items is the total SGRQ score which also ranges from 0 to 100%. The SGRQ scores are calculated using weights attached to each item of the questionnaire which provides an estimate of the distress associated with the symptoms or state described in each item. Higher scores indicate poorer health. A decrease of at least 4 units in the SGRQ total score has been established as the criterion for minimal meaningful improvement. SGRQ responders will be those with a decrease in SGRQ total score of at least 4 units from baseline.

Time frame:: At baseline and Week 24
Reported as:: Count of participants · Participants

Responder (Number of Participants) Analysis of St. George's Respiratory Questionnaire (SGRQ) Total Score With AB/FF 400/12 μg Versus AB 400 μg and FF 12 μg.
Participants	AB/FF 400/12 μg	AB 400 μg	FF 12 μg	TIO 18 μg
Number of responders -Yes	130	188	128	197
Number of responders- NO	140	195	130	192

Statistical analysis

AB/FF 400/12 μg vs AB 400 μg · Logistic random-effect model · p = 0.8714 · Odds ratio: 0.96 · 95% CI 0.61 to 1.51
AB/FF 400/12 μg vs FF 12 μg · Logistic random-effect model · p = 0.8873 · Odds ratio: 0.97 · 95% CI 0.59 to 1.58

Adverse events

Collected over From time of signature of the ICF throughout the treatment period and including the follow-up period (14 days after the last study drug administration). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AB/FF 400/12 μg	1/314 (0.3%)	23/314 (7.3%)	173/314 (55.1%)
AB 400 μg	1/475 (0.2%)	41/475 (8.6%)	222/475 (46.7%)
FF 12 μg	4/319 (1.3%)	22/319 (6.9%)	178/319 (55.8%)
TIO 18 μg	2/475 (0.4%)	37/475 (7.8%)	241/475 (50.7%)

Most frequent serious events

Showing 10 of 85

Most frequent serious events
Event	AB/FF 400/12 μg	AB 400 μg	FF 12 μg	TIO 18 μg
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders	7/314	11/475	10/319	14/475
PneumoniaInfections and infestations	4/314	3/475	1/319	2/475
Myocardial infarctionCardiac disorders	0/314	0/475	0/319	3/475
Cardiac failure acuteCardiac disorders	0/314	2/475	0/319	0/475
Cardiac failure congestiveCardiac disorders	0/314	2/475	0/319	0/475
Atrial fibrillationCardiac disorders	0/314	1/475	0/319	2/475
AppendicitisInfections and infestations	1/314	0/475	0/319	0/475
SepsisInfections and infestations	1/314	0/475	0/319	0/475
Angina pectorisCardiac disorders	1/314	0/475	0/319	1/475
Atrial tachycardiaCardiac disorders	1/314	0/475	0/319	0/475

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	AB/FF 400/12 μg	AB 400 μg	FF 12 μg	TIO 18 μg
Chronic obstructive pulmonaryRespiratory, thoracic and mediastinal disorders	49/314	79/475	58/319	61/475
NasopharyngitisInfections and infestations	36/314	47/475	39/319	64/475
HeadacheNervous system disorders	16/314	19/475	17/319	25/475
Back painMusculoskeletal and connective tissue disorders	15/314	7/475	8/319	7/475
Upper respiratory tract infectionInfections and infestations	8/314	13/475	7/319	17/475
CoughRespiratory, thoracic and mediastinal disorders	6/314	7/475	4/319	17/475
HypertensionVascular disorders	7/314	8/475	9/319	7/475
DyspnoeaRespiratory, thoracic and mediastinal disorders	6/314	13/475	6/319	12/475
SinusitisInfections and infestations	8/314	10/475	6/319	7/475
ArthralgiaMusculoskeletal and connective tissue disorders	8/314	4/475	3/319	8/475

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Aclidinium Bromide (AB)/Formoterol Fumarate (FF) 400/12 μg	AB 400 μg	FF 12 μg	Tiotropium (TIO) 18 μg	Total
Mean	64.4 ± 8.5	64.4 ± 8.1	64.7 ± 8.3	64.0 ± 8.6	64.3 ± 8.4

Sex: Female, Male
Sex: Female, Male(Participants)	Aclidinium Bromide (AB)/Formoterol Fumarate (FF) 400/12 μg	AB 400 μg	FF 12 μg	Tiotropium (TIO) 18 μg	Total
Female	121	171	129	199	620
Male	193	304	190	276	963

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Aclidinium Bromide (AB)/Formoterol Fumarate (FF) 400/12 μg	AB 400 μg	FF 12 μg	Tiotropium (TIO) 18 μg	Total
American Indian or Alaska Native	0	1	0	0	1
Asian	0	2	0	2	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	17	28	16	16	77
White	297	444	303	457	1501
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Study locations

163 sites

Research Site
Gulf Shores, Alabama 36542, United States
Research Site
Phoenix, Arizona 85018, United States
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Tucson, Arizona 85712, United States
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Corona, California 92879, United States
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Fresno, California 93702, United States
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Fullerton, California 92835, United States
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Lincoln, California 95648, United States
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San Diego, California 92120, United States
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Waterbury, Connecticut 06708, United States
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Clearwater, Florida 33765, United States
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Edgewater, Florida 32132, United States
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Hollywood, Florida 33021, United States
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Homestead, Florida 33030, United States
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Miami Lakes, Florida 33016, United States
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Miami, Florida 33144, United States
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Miami, Florida 33186, United States
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Ormond Beach, Florida 32174, United States
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Port Orange, Florida 32129, United States
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Saint Petersburg, Florida 33704, United States
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Saint Petersburg, Florida 33709, United States
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Sarasota, Florida 34233, United States
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Tampa, Florida 33603, United States
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Winter Park, Florida 32789, United States
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Blue Ridge, Georgia 30513, United States
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Woodstock, Georgia 30189, United States
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Chicago, Illinois 60602, United States
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Portage, Indiana 46368, United States
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Lafayette, Louisiana 70508, United States
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Fall River, Massachusetts 02720, United States
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Chelsea, Michigan 48118, United States
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Farmington Hills, Michigan 48336, United States
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Troy, Michigan 48085, United States
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Edina, Minnesota 55435, United States
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Fridley, Minnesota 55432, United States
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Minneapolis, Minnesota 55407, United States
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Woodbury, Minnesota 55125, United States
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Saint Charles, Missouri 63301, United States
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Saint Louis, Missouri 63117, United States
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Saint Louis, Missouri 63141, United States
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Fremont, Nebraska 68025, United States
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Omaha, Nebraska 68114, United States
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Omaha, Nebraska 68134, United States
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Las Vegas, Nevada 89102, United States
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Bronx, New York 10455, United States
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Brooklyn, New York 11230, United States
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Buffalo, New York 14215, United States
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New York, New York 10036, United States
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Rochester, New York 14618, United States
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Charlotte, North Carolina 28207, United States
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Charlotte, North Carolina 28277, United States
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Gastonia, North Carolina 28054, United States
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Wilmington, North Carolina 28401, United States
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Canton, Ohio 44718, United States
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Cincinnati, Ohio 45231, United States
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Cincinnati, Ohio 45242, United States
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Cincinnati, Ohio 45246, United States
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Columbus, Ohio 43207, United States
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Columbus, Ohio 43215, United States
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Dublin, Ohio 43016, United States
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Grove City, Ohio 43123, United States
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Edmond, Oklahoma 73034, United States
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Midwest City, Oklahoma 73110, United States
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Oklahoma City, Oklahoma 73104, United States
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Medford, Oregon 97504, United States
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Altoona, Pennsylvania 16602, United States
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Pittsburgh, Pennsylvania 15243, United States
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Wyomissing, Pennsylvania 19610, United States
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East Providence, Rhode Island 02914, United States
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Columbia, South Carolina 29204, United States
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Gaffney, South Carolina 29340, United States
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Mount Pleasant, South Carolina 29464, United States
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Spartanburg, South Carolina 29303, United States
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Union, South Carolina 29379, United States
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Arlington, Texas 76012, United States
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Baytown, Texas 77521, United States
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Boerne, Texas 78006, United States
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Dallas, Texas 75225, United States
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Fort Worth, Texas 76104, United States
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Houston, Texas 77074, United States
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Lewisville, Texas 75067, United States
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McKinney, Texas 75069, United States
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Tomball, Texas 77375, United States
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Midvale, Utah 84047, United States
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Abingdon, Virginia 24210, United States
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Newport News, Virginia 23606, United States
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Dimitrovgrad, 6400, Bulgaria
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Gabrovo, 5300, Bulgaria
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Roman, 3130, Bulgaria
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Ruse, 7002, Bulgaria
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Sevlievo, 5400, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1002, Bulgaria
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Sofia, 1431, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Vidin, 3700, Bulgaria
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Jaromer, 544 01, Czechia
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Jindrichuv Hradec, 377 01, Czechia
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Praha 8, 182 00, Czechia
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Rokycany, 33722, Czechia
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Strakonice, 38601, Czechia

Showing the first 100 of 163 sites across 10 countries.

References and documents

Publications

Sethi S, Kerwin E, Watz H, Ferguson GT, Mroz RM, Segarra R, Molins E, Jarreta D, Garcia Gil E. AMPLIFY: a randomized, Phase III study evaluating the efficacy and safety of aclidinium/formoterol vs monocomponents and tiotropium in patients with moderate-to-very severe symptomatic COPD. Int J Chron Obstruct Pulmon Dis. 2019 Mar 22;14:667-682. doi: 10.2147/COPD.S189138. eCollection 2019. PubMed 30962681 ↗

Study documents

Study protocol · Mar 21, 2016
Statistical analysis plan · Jul 4, 2017

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02796677
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Jun 13, 2016
Start date: Jul 5, 2016
Primary completion: Jun 8, 2017
Completion: Jun 8, 2017
Results posted: Nov 9, 2018
Last update: Nov 9, 2018

Study contacts

Sanjay Sethi

principal investigator · 3495 Bailey Ave , Buffalo NY14215, USA

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes

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