AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01462942

Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

A Phase 3 study testing Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 197 sites in 22 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

The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide and Formoterol Fumarate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,443 participants
Where
197 sitesin 22 countries
Study dates
Oct 2011to Jan 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential are allowed to enter the trial if they show to have a negative serum pregnancy test at the Screening Visit and are using, during the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal Intrauterine Devices (IUDs), sexual abstinence or vasectomy of the partner.
  • Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years.
  • Patient with a clinical diagnosis of stable COPD according to the Global Initiative for Chronic Lung Disease "GOLD" Guidelines at the Screening Visit.
  • Patient whose FEV1/FVC (Forced Vital Capacity) at the Screening Visit measured between 10-15 minutes post inhalation of 400 micrograms of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
  • Patient with a diagnosis of moderate to severe COPD according to the GOLD Guidelines classification (stages II and III) at the Screening Visit: FEV1 measured between 10-15 minutes post inhalation of 400 micro grams of salbutamol is 30% < FEV1 < 80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be < 80% and ≥ 30%).
  • Patient must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society/European Respiratory Society "ATS/ERS" 2005 criteria at Screening Visit.
  • Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.

Who cannot join

  • History or current diagnosis of asthma.
  • Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Screening Visit.
  • Patient hospitalised for COPD exacerbation within 3 months prior to Screening Visit.
  • Clinically significant respiratory conditions defined as:
  • Known active tuberculosis.
  • History of interstitial lung or massive pulmonary thromboembolic disease.
Show all 38Show fewer
  • Pulmonary resection or lung volume reduction surgery within 12 months prior to Screening Visit.
  • History of lung transplantation.
  • History of bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc).
  • Known a1-antitrypsin deficiency.
  • Patients who in the Investigator's opinion might have needed 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 did not maintain regular day/night, waking/sleeping cycles including night shift workers (eg, history of sleep apnoea syndrome, any condition related to sleep disturbances such as restless-legs syndrome or somnambulism).
  • Clinically significant cardiovascular conditions defined as:
  • Myocardial infarction within the 6 months prior to screening.
  • Thoracic surgery within 12 months prior to screening.
  • Unstable angina or unstable arrhythmia which had required changes in the pharmacological therapy or other intervention within 12 months prior to screening, or newly diagnosed arrhythmia within the previous 3 months prior to screening.
  • Hospitalisation within 12 months prior to screening for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.
  • Patients (with or without pharmacological therapy) with resting systolic blood pressure (SBP)
  • ≥200 mmHg, a resting diastolic blood pressure (DBP) ≥120 mmHg, or a resting heart rate ≥105 beats per minute (bpm) at screening and at Visit 1 prior to randomisation.
  • Patients with interval corrected for heart rate "QTc" [calculated according to formulae (QTc=QT/RR1/2) > 470 msec as indicated in the centralised reading report assessed at Screening Visit.
  • Patients with clinically relevant abnormalities in the clinical laboratory tests, ECG parameters (other than QT interval corrected using Bazett's formula [QTcB]) or in the physical examination at screening, if the abnormality defined a disease state listed as exclusion criteria, except for those related to COPD.
  • Patients with a history of hypersensitivity reactions to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm). Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction or acute urinary retention.
  • Patients with symptomatic non-stable prostate hypertrophy. (However, patients with well-controlled, stable, asymptomatic benign prostatic hypertrophy were not excluded).
  • Patients with known uncontrolled history of infection with human immunodeficiency virus and/or active hepatitis.
  • Current diagnosis of cancer other than basal or squamous cell skin cancer.
  • Life expectancy of less than 1 year.
  • Patients with any other serious or uncontrolled physical or mental dysfunction that, as judged by the Investigator, could have placed the patient at higher risk from his/her participation in the study, could have confounded the results of the study, or is likely to prevent the patient from complying with the requirements of the study, or completing the study.
  • Patients with a history (within 2 years prior to screening) of drug and/or alcohol abuse that might have prevented study compliance based on the Investigator judgment.
  • Patients unlikely to be cooperative (eg, take the medication, complete the Patient Diaries or attend the clinic at the required times).
  • Patients unable to properly use a DPI or pMDI inhaler device or to perform spirometry measurements.
  • Patients previously randomised in a study involving aclidinium bromide/formoterol FDC.
  • Patients previously randomised in a study involving aclidinium bromide monotherapy except when participation finished at least 6 months before screening.
  • 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 employed, or relatives of employees at the study centre, Almirall or Forest Laboratories.
  • Any other conditions that, in the Investigator's opinion, might have indicated the patient to be unsuitable for the study.

Trial locations and contacts

197 sites in 22 countries.

197 sites in 22 countries

Germany28 sites

  • Almirall Investigational Site #2

    Berlin, 10117

  • Almirall Investigational Site #12

    Berlin, 10629

  • Almirall Investigational Site #19

    Berlin, 12627

  • Almirall Investigational Site #11

    Berlin, 13125

  • Almirall Investigational Site #24

    Berlin, 14059

  • Almirall Investigational Site #16

    Bochum, 44787

  • Almirall Investigational Site #23

    Bonn, 53123

  • Almirall Investigational Site #15

    Dresden, 1067

  • Almirall Investigational Site #10

    Dresden, 1307

  • Almirall Investigational Site #5

    Frankfurt, 60389

  • Almirall Investigational Site #13

    Frankfurt, 60596

  • Almirall Investigational Site #33

    Haltern am See, 44263

  • Almirall Investigational Site #7

    Hamburg, 20253

  • Almirall Investigational Site #21

    Hamburg, 22143

  • Almirall Investigational Site #36

    Hessen, 60596

  • Almirall Investigational Site #32

    Land Niedersachsen, 30159

  • Almirall Investigational Site #1

    Lübeck, 23538

  • Almirall Investigational Site #6

    Mainz, 55131

  • Almirall Investigational Site #20

    Marburg, 35037

  • Almirall Investigational Site #34

    München, 80539

  • Almirall Investigational Site #18

    Nuremberg, 90402

  • Almirall Investigational Site #22

    Reinfeld, 23858

  • Almirall Investigational Site #35

    Sachsen, 1067

  • Almirall Investigational Site #27

    Sachsen, 2826

  • Almirall Investigational Site #28

    Sachsen, 39104

  • Almirall Investigational Site #25

    Sachsen, 4103

  • Almirall Investigational Site #8

    Schwerin, 19055

  • Almirall Investigational Site #4

    Witten, 58452

Other trials in Germany

Poland21 sites

  • Almirall Investigational Site #26

    Bialystok, 15-003

  • Almirall Investigational Site #3

    Bialystok, 15-540

  • Almirall Investigational Site #19

    Bielsko-Biala, 43-316

  • Almirall Investigational Site #23

    Bydgoszcz, 85-079

  • Almirall Investigational Site #21

    Gdynia, 81-384

  • Almirall Investigational Site #5

    Katowice, 40-748

  • Almirall Investigational Site #22

    Katowice, 40-751

  • Almirall Investigational Site #7

    Krakow, 31-024

  • Almirall Investigational Site #9

    Krakow, 31-159

  • Almirall Investigational Site #6

    Lodz, 92-216

  • Almirall Investigational Site #1

    Lodz, 93-319

  • Almirall Investigational Site #14

    Lublin, 20-718

  • Almirall Investigational Site #8

    Oława, 55-200

  • Almirall Investigational Site #2

    Poznan, 60-214

  • Almirall Investigational Site #11

    Poznan, 60-693

  • Almirall Investigational Site #4

    Poznan, 60-823

  • Almirall Investigational Site #13

    Torun, 87-100

  • Almirall Investigational Site #18

    Torun, 87-100

  • Almirall Investigational Site #10

    Warsaw, 01-138

  • Almirall Investigational Site #15

    Warsaw, 01-138

  • Almirall Investigational Site #16

    Warsaw, 01-868

Other trials in Poland

United Kingdom16 sites

  • Almirall Investigational Site #6

    Birmingham, B15 2SQ

  • Almirall Investigational Site #12

    Bradford, BD9 6RJ

  • Almirall Investigational Site #10

    Cambridge, CB2 2QQ

  • Almirall Investigational Site #13

    Cardiff, CF14 5GJ

  • Almirall Investigational Site #5

    Chorley, PR7 7NA

  • Almirall Investigational Site #2

    Glasgow, G81 2DR

  • Almirall Investigational Site #11

    Hull, HU16 5JQ

  • Almirall Investigational Site #14

    Liverpool, L22 0LG

  • Almirall Investigational Site #1

    London, E2 9JX

  • Almirall Investigational Site #4

    Manchester, M15 6SX

  • Almirall Investigational Site #8

    Manchester, M23 9QZ

  • Almirall Investigational Site #17

    Metropolitan Borough of Wirral, CH49 5PE

  • Almirall Investigational Site #18

    Newcastle upon Tyne, NE7 7DN

  • Almirall Investigational Site #7

    Reading, RG2 7AG

  • Almirall Investigational Site #16

    Stockton-on-Tees, TS19 8PE

  • Almirall Investigational Site #15

    West Midlands, WV10 0QP

Other trials in United Kingdom

Hungary15 sites

  • Almirall Investigational Site #4

    Balassagyarmat, 2660

  • Almirall Investigational Site #16

    Budapest, 1033

  • Almirall Investigational Site #12

    Budapest, 1036

  • Almirall Investigational Site #17

    Budapest, 1036

  • Almirall Investigational Site #6

    Budapest, 1125

  • Almirall Investigational Site #14

    Budapest, 1221

  • Almirall Investigational Site #5

    Budapest, 1529

  • Almirall Investigational Site #1

    Deszk, 6772

  • Almirall Investigational Site #9

    Komárom, 2900

  • Almirall Investigational Site #2

    Miskolc, 3534

  • Almirall Investigational Site #15

    Mosonmagyaróvár, 9200

  • Almirall Investigational Site #13

    Nagykanizsa, 8800

  • Almirall Investigational Site #3

    Nyíregyháza, 4400

  • Almirall Investigational Site #7

    Törökbálint, 2045

  • Almirall Investigational Site #11

    Zalaegerszeg, 8900

Other trials in Hungary

Ukraine14 sites

  • Almirall Investigational Site #18

    Crimea Oblast, 98603

  • Almirall Investigational Site #12

    Dnipropetrovsk, 49051

  • Almirall Investigational Site #9

    Donetsk, 83099

  • Almirall Investigational Site #11

    Ivano-Frankivsk, 76012

  • Almirall Investigational Site #1

    Kharkiv, 61035

  • Almirall Investigational Site #17

    Kharkiv, 61039

  • Almirall Investigational Site #15

    Kyiv, 03680

  • Almirall Investigational Site #2

    Kyiv, 3680

  • Almirall Investigational Site #3

    Kyiv, 3680

  • Almirall Investigational Site #4

    Kyiv, 3680

  • Almirall Investigational Site #5

    Kyiv, 4050

  • Almirall Investigational Site #6

    Luhansk, 91045

  • Almirall Investigational Site #8

    Mykolaiv, 54003

  • Almirall Investigational Site #10

    Vinnytsia, 21029

Other trials in Ukraine

Czechia12 sites

  • Almirall Investigational Site #8

    Brno, 65691

  • Almirall Investigational Site #3

    Jindřichův Hradec, 377 01

  • Almirall Investigational Site #10

    Karlovy Vary, 360 00

  • Almirall Investigational Site #9

    Liberec, 460 63

  • Almirall Investigational Site #16

    Ostrava Hrabuvka, 700 30

  • Almirall Investigational Site #2

    Prague, 130 00

  • Almirall Investigational Site #12

    Prague, 155 00

  • Almirall Investigational Site #15

    Prague, 163 00

  • Almirall Investigational Site #14

    Prague, 18200

  • Almirall Investigational Site #6

    Praha 5 - Radotin, 153 00

  • Almirall Investigational Site #11

    Strakonice, 386 01

  • Almirall Investigational Site #1

    Tábor, 390 01

Other trials in Czechia

Romania12 sites

  • Almirall Investigational Site #1

    Brasov, 500075

  • Almirall Investigational Site #9

    Bucharest, 21382

  • Almirall Investigational Site #18

    Bucharest, 21659

  • Almirall Investigational Site #7

    Bucharest, 30303

  • Almirall Investigational Site #10

    Bucharest, 50554

  • Almirall Investigational Site #17

    Constanța, 900002

  • Almirall Investigational Site #2

    Constanța, 900002

  • Almirall Investigational Site #3

    Craiova, 200515

  • Almirall Investigational Site #8

    Deva, 330084

  • Almirall Investigational Site #6

    Iași, 700115

  • Almirall Investigational Site #16

    Iași, 700381

  • Almirall Investigational Site #5

    Târgu Mureş, RO540136

Other trials in Romania

South Africa9 sites

  • Almirall Investigational Site #16

    Cape Town, 7500

  • Almirall Investigational Site #2

    Cape Town, 7500

  • Almirall Investigational Site #15

    Cape Town, Western Cape, 7700

  • Almirall Investigational Site #1

    eManzimtoti, 4126

  • Almirall Investigational Site #12

    Pretoria, 2

  • Almirall Investigational Site #13

    Pretoria, 2

  • Almirall Investigational Site #3

    Pretoria, 84

  • Almirall Investigational Site #8

    Roodepoort, 1724

  • Almirall Investigational Site #5

    Somerset West, 7129

Other trials in South Africa

South Korea8 sites

  • Almirall Investigational Site #7

    Buchon-si, 420-767

  • Almirall Investigational Site #4

    Gyeonggi-do, 431-070

  • Almirall Investigational Site #8

    Seoul, 110-744

  • Almirall Investigational Site #6

    Seoul, 120-752

  • Almirall Investigational Site #3

    Seoul, 136-705

  • Almirall Investigational Site #5

    Seoul, 137-710

  • Almirall Investigational Site #2

    Seoul, 152-703

  • Almirall Investigational Site #1

    Seoul, 158-710

Other trials in South Korea

France7 sites

  • Almirall Investigational Site #6

    Lille, 59037

  • Almirall Investigational Site #10

    Marseille, 13291

  • Almirall Investigational Site #11

    Montpellier, 34295

  • Almirall Investigational Site #1

    Pessac, 33604

  • Almirall Investigational Site #3

    Rennes, 35033

  • Almirall Investigational Site #8

    Toulouse, 31059

  • Almirall Investigational Site #12

    Vieux-Condé, 59690

Other trials in France

Netherlands7 sites

  • Almirall Investigational Site #8

    Beek, 6191 JW

  • Almirall Investigational Site #7

    Breda, 4811 VL

  • Almirall Investigational Site #13

    Eindhoven, 5632 EJ

  • Almirall Investigational Site #1

    Leiderdorp, 2352 RA

  • Almirall Investigational Site #9

    Rotterdam, 3021 HC

  • Almirall Investigational Site #11

    Velp, 6883 ES

  • Almirall Investigational Site #10

    Zoetermeer, 2724 EK

Other trials in Netherlands

Slovakia7 sites

  • Almirall Investigational Site #6

    Banská Bystrica, 975 17

  • Almirall Investigational Site #5

    Bardejov, 8501

  • Almirall Investigational Site #3

    Bratislava, 821 06

  • Almirall Investigational Site #1

    Nové Zámky, 940 01

  • Almirall Investigational Site #4

    Spišská Nová Ves, 5201

  • Almirall Investigational Site #9

    Štúrovo, 943 01

  • Almirall Investigational Site #10

    Vyšné Hágy, 059 84

Other trials in Slovakia

Spain7 sites

  • Almirall Investigational Site #7

    Barcelona, 8003

  • Almirall Investigational Site #12

    Barcelona, 8916

  • Almirall Investigational Site #10

    Cáceres, 10003

  • Almirall Investigational Site #3

    Canet de Mar, 8360

  • Almirall Investigational Site #1

    Málaga, 29010

  • Almirall Investigational Site #9

    Oviedo, 33006

  • Almirall Investigational Site #8

    Seville, 41071

Other trials in Spain

Bulgaria5 sites

  • Almirall Investigational Site #6

    Rousse, 7002

  • Almirall Investigational Site #10

    Sevlievo, 5400

  • Almirall Investigational Site #8

    Sofia, 1000

  • Almirall Investigational Site #2

    Sofia, 1431

  • Almirall Investigational Site #11

    Sofia, 1709

Other trials in Bulgaria

Finland5 sites

  • Almirall Investigational Site #7

    Espoo, 2740

  • Almirall Investigational Site #8

    Jyväskylä, 40100

  • Almirall Investigational Site #1

    Tampere, 33520

  • Almirall Investigational Site #6

    Tampere, 33520

  • Almirall Investigational Site #3

    Turku, 20520

Other trials in Finland

Russia5 sites

  • Almirall Investigational Site #2

    Moscow, 109240

  • Almirall Investigational Site #1

    Moscow, 119620

  • Almirall Investigational Site #9

    Novosibirsk, 630089

  • Almirall Investigational Site #7

    Saint Petersburg, 194044

  • Almirall Investigational Site #12

    Saint Petersburg, 194354

Other trials in Russia

Sweden5 sites

  • Almirall Investigational Site #2

    Gothenburg, 41263

  • Almirall Investigational Site #1

    Lund, 22185

  • Almirall Investigational Site #6

    Lund, 22222

  • Almirall Investigational Site #3

    Malmö, 21152

  • Almirall Investigational Site #4

    Vällingby, 16268

Other trials in Sweden

Denmark4 sites

  • Almirall Investigational Site #4

    Hillerød, 3400

  • Almirall Investigational Site #1

    København NV, 2400

  • Almirall Investigational Site #5

    Odense, 5000

  • Almirall Investigational Site #2

    Silkeborg, 8600

Other trials in Denmark

Italy4 sites

  • Almirall Investigational Site #15

    Genova, 16132

  • Almirall Investigational Site #3

    Parma, 43100

  • Almirall Investigational Site #5

    Pisa, 56124

  • Almirall Investigational Site #1

    Siena, 53100

Other trials in Italy

Austria2 sites

  • Almirall Investigational Site #2

    Graz, 8036

  • Almirall Investigational Site #3

    Salzburg, 5020

Other trials in Austria

Belgium2 sites

  • Almirall Investigational Site #3

    Edegem, 2650

  • Almirall Investigational Site #2

    Genk, 3600

Other trials in Belgium

Croatia2 sites

  • Almirall Investigational Site #2

    Zagreb, 10000

  • Almirall Investigational Site #4

    Zagreb, 10000

Other trials in Croatia

About this study

Official title: Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

Read the detailed description

This Phase III study seeks to confirm the long-term bronchodilator efficacy and effects on COPD related health status and other secondary parameters as well as the safety of two doses of the combination of aclidinium bromide/formoterol FDC (FDC 400/12 μg and 400/6 μg) compared with aclidinium bromide monotherapy 400 μg, formoterol monotherapy 12 μg and placebo.

Being tested
Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Placebo, Formoterol Fumarate
Keywords
COPD, Bronchitis, Chronic, Emphysema
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Bronchitis, Bronchiolitis Obliterans Syndrome, Emphysema

What participants receive

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

  • Aclidinium Bromide/Formoterol FumarateDrug

    Inhaled Aclidinium/formoterol Fixed Dose Combination (FDC) low dose (400/6 μg), twice per day

  • Aclidinium Bromide/Formoterol FumarateDrug

    Inhaled Aclidinium/formoterol FDC high dose (400/12 μg), twice per day

  • Aclidinium BromideDrug

    Inhaled Aclidinium 400 μg, twice per day

  • PlaceboDrug

    Inhaled dose-matched placebo, twice per day

  • Formoterol FumarateDrug

    Inhaled Formoterol 12 μg, twice per day

Study groups in NCT01462942
Study groupRoleWhat they receive
Aclidinium/Formoterol 400/6 μgExperimental24 week, double blind treatment period
Receives: Drug: Aclidinium Bromide/Formoterol Fumarate
Aclidinium/Formoterol 400/12 μgExperimental24 week, double blind treatment period
Receives: Drug: Aclidinium Bromide/Formoterol Fumarate
Aclidinium monotherapy 400 μgExperimental24 week, double blind treatment period
Receives: Drug: Aclidinium Bromide
Formoterol monotherapy 12 μgActive comparator24 week, double blind treatment period
Receives: Drug: Formoterol Fumarate
PlaceboPlacebo comparator24 week, double blind treatment period
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)

    Measured: Baseline and Week 24

  2. Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)

    Measured: Baseline and Week 24

Secondary outcomes (2)

  1. Change in Transition Dyspnoea Index (TDI) Focal Score

    Evaluation of dyspnea was performed by an independent interviewer experienced in taking a respiratory history The TDI includes three categories: functional impairment which determines the impact of breathlessness on the ability to perform activities, magnitude of task which determines the type of task that caused breathlessness and magnitude of effort which establishes the level of effort needed to evoke breathlessness Each category ranges from minus three (-3; major deterioration) to plus three (+3; major improvement) including a zero (0) score to indicate 'no change' The three categories are totalled to obtain a focal score (total score) ranging from minus nine (-9), including zero (0), to plus nine (+9) Provision is made for circumstances when dyspnoea could not be rated - if reduction of activities, effort or functional impairment was caused by reasons other than respiratory A change of 1 unit in TDI is used as the criterion for a minimal meaningful improvement

    Measured: Baseline and Week 24

  2. Change From Baseline in St. George´s Respiratory Questionnaire (SGRQ) Total Score

    SGRQ is a standardised, self-administered tool for measuring impaired health and perceived well-being in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact) Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100: zero (0) score indicating no impairment of quality of life The total SGRQ score ranging from 0 to 100 is a summary score utilising responses to all items calculated using weights attached to each item of the questionnaire Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status

    Measured: Baseline and Week 24

Timeline

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

  1. First posted1 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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
2,443 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01462942
Sponsor's protocol ID
M/40464/30
Status last verified
Dec 2016
First submitted
26 Oct 2011
Last updated
15 Feb 2017
Data monitoring committee
No

Publications

  • Singh D, D'Urzo AD, Donohue JF, Kerwin EM, Molins E, Chuecos F, Ribera A, Jarreta D. An Evaluation Of Single And Dual Long-Acting Bronchodilator Therapy As Effective Interventions In Maintenance Therapy-Naive Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2019 Dec 6;14:2835-2848. doi: 10.2147/COPD.S217710. eCollection 2019.

    PubMed 31827323

  • Singh D, D'Urzo AD, Chuecos F, Munoz A, Garcia Gil E. Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol. Respir Res. 2017 May 30;18(1):106. doi: 10.1186/s12931-017-0583-0.

    PubMed 28558833

  • Bateman ED, Chapman KR, Singh D, D'Urzo AD, Molins E, Leselbaum A, Gil EG. Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT). Respir Res. 2015 Aug 2;16(1):92. doi: 10.1186/s12931-015-0250-2.

    PubMed 26233481

  • Singh D, Jones PW, Bateman ED, Korn S, Serra C, Molins E, Caracta C, Gil EG, Leselbaum A. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014 Nov 18;14:178. doi: 10.1186/1471-2466-14-178.

    PubMed 25404569

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 197 sites in 22 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 7 inclusion and 38 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 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in Germany, Poland, United Kingdom, Hungary, Ukraine and 17 more countries. 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 15 Feb 2017). 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-dose Forced Expiratory Volume in One Second (FEV1) (time frame: Baseline and Week 24). The study lists 2 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 NCT01462942, which also lists 4 linked publications.

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 15 Feb 2017.

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