Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01001494
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 3 study testing Aclidinium bromide 200 μg bid and Aclidinium bromide 400 μg bid in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 106 sites in 11 countries.
Trial summary
The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Aclidinium bromide 200 μg bid and Aclidinium bromide 400 μg bid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 828 participants
- Where
- 106 sitesin 11 countries
- Study dates
- Oct 2009to Nov 2010
- 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 and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
- Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
- Current or ex-smokers of ≥10 pack-years.
Who cannot join
- Patients with no history or current diagnosis of asthma.
- No evidence of an exacerbation within 6 weeks prior to the screening visit.
- No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
- No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Trial locations and contacts
106 sites in 11 countries.
106 sites in 11 countries
Poland22 sites
Almirall Investigational Sites#12
Bialystok, 15-003
Almirall Investigational Sites#9
Bialystok, 15-540
Almirall Investigational Sites#19
Elblag, 82-307
Almirall Investigational Sites#18
Gdansk, 80-211
Almirall Investigational Sites#20
Iława, 14-200
Almirall Investigational Sites#7
Lodz, 90-430
Almirall Investigational Sites#1
Lodz, 91-153
Almirall Investigational Sites#8
Lublin
Almirall Investigational Sites#24
Olsztyn, 10-357
Almirall Investigational Sites#5
Olsztyn, 10-357
Almirall Investigational Sites#21
Poznan, 60-214
Almirall Investigational Sites#16
Poznan, 60-693
Almirall Investigational Site#11
Proszowice, 32-100
Almirall Investigational Sites#2
Ruda Śląska, 41-709
Almirall Investigational Sites#13
Rudka, 05-320
Almirall Investigational Sites#4
Sopot, 81-741
Almirall Investigational Sites#14
Szczecin, 70-111
Almirall Investigational Sites#15
Tarnów, 33-100
Almirall Investigational Sites#6
Tarnów, 33-100
Almirall Investigational Sites#25
Warsaw, 01-138
Almirall Investigational Sites#23
Wilkowice-Bystra, 43-365
Almirall Investigational Site#10
Wroclaw, 50-349
Germany17 sites
Almirall Investigational Sites#8
Berlin, 10117
Almirall Investigational Sites#9
Berlin, 10969
Almirall Investigational Sites#6
Berlin, 13125
Almirall Investigational Sites#14
Berlin, 13507
Almirall Investigational Site#7
Berlin, 14057
Almirall Investigational Sites#12
Bonn, 53123
Almirall Investigational Sites#10
Cologne, 51069
Almirall Investigational Sites#3
Dortmund, 44263
Almirall Investigational Sites#13
Frankfurt, 60596
Almirall Investigational Sites#15
Gelsenkirchen, 45879
Almirall Investigational Sites#1
Großhansdorf, 22927
Almirall Investigational Sites#5
Hamburg, 20249
Almirall Investigational Sites#4
Hamburg, 22143
Almirall Investigational Site#16
Hanover, 30159
Almirall Investigational Sites#18
Jena, 07743
Almirall Investigational Sites#11
Mainz, 55131
Almirall Investigational Site#2
Rüdersdorf, 15562
Hungary13 sites
Almirall Investigational Sites#13
Budapest, 1036
Almirall Investigational Sites#4
Budapest, 1046
Almirall Investigational Sites#1
Budapest, 1125
Almirall Investigational Sites#2
Budapest, 1529
Almirall Investigational Sites#6
Debrecen, 4032
Almirall Investigational Sites#5
Debrecen, 4043
Almirall Investigational Sites#7
Deszk, 6772
Almirall Investigational Sites#10
Dunaüjváros, 2400
Almirall Investigational Sites#9
Mátraháza, 3233
Almirall Investigational Sites#12
Pécs, 7621
Almirall Investigational Sites#11
Ráckeve, 2300
Almirall Investigational Sites#3
Százhalombatta, 2440
Almirall Investigational Sites#8
Zalaegerszeg, 8900
South Africa13 sites
Almirall Investigational Sites#8
Bloemfontein, 9300
Almirall Investigational Sites#11
Bloemfontein, 9301
Almirall Investigational Sites#3
Bloemfontein, 9301
Almirall Investigational Sites#10
Cape Town, 7500
Almirall Investigational Sites#1
Cape Town, 7505
Almirall Investigational Sites#12
Cape Town
Almirall Investigational Sites#15
Cape Town
Almirall Investigational Sites#2
Durban
Almirall Investigational Sites#9
George, 6529
Almirall Investigational Sites#4
Port Elizabeth, 6045
Almirall Investigational Sites#5
Pretoria, 0002
Almirall Investigational Sites#14
Pretoria, 0081
Almirall Investigational Sites#6
Pretoria, 181
Russia11 sites
Almirall Investigational Sites#5
Kazan', 420015/420103
Almirall Investigational Sites#2
Moscow, 115446
Almirall Investigational Sites#14
Moscow, 123182
Almirall Investigational Sites#6
Moscow, 127018/127473
Almirall Investigational Sites#13
Novosibirsk, 630008
Almirall Investigational Sites#10
Saint Petersburg, 194354
Almirall Investigational Sites#3
Saint Petersburg, 197022
Almirall Investigational Sites#4
Saint Petersburg, 197089/197022
Almirall Investigational Sites#8
Tomsk, 634050/634034
Almirall Investigational Sites#12
Tomsk, 634050
Almirall Investigational Sites#7
Yekaterinburg, 620219 / 620109
Czechia10 sites
Almirall Investigational Sites#4
Benešov, 256 01
Almirall Investigational Sites#9
Jaroměř, 55 101
Almirall Investigational Sites#3
Liberec, 460 01
Almirall Investigational Sites#2
Lovosice, 410 02
Almirall Investigational Sites#1
Neratovice, 277 11
Almirall Investigational Sites#11
Prague, 158 00
Almirall Investigational Sites#6
Prague, 158 00
Almirall Investigational Sites#12
Prague, 163 00
Almirall Investigational Sites#7
Prague, 169 00
Almirall Investigational Sites#10
Strakonice, 386 01
Ukraine6 sites
Almirall Investigational Sites#4
Donetsk, 83099
Almirall Investigational Sites#3
Kharkiv, 61001
Almirall Investigational Sites#1
Kyiv, 03680
Almirall Investigational Sites#2
Kyiv, 03680
Almirall Investigational Sites#7
Kyiv, 04050
Almirall Investigational Sites#5
Zaporizhzhya, 69118
France5 sites
Almirall Investigational Sites#3
Clermont-Ferrand, 63003
Almirall Investigational Sites#2
Marseille, 13008
Almirall Investigational Sites#1
Marseille, 13915
Almirall Investigational Sites#6
Montpellier, 34295
Almirall Investigational Sites#4
Toulouse, 31059
Spain5 sites
Almirall Investigational Sites#6
Badalona, 08916
Almirall Investigational Sites#8
Barcelona, 08035
Almirall Investigational Sites#7
Barcelona, 08036
Almirall Investigational Sites#3
Madrid, 28041
Almirall Investigational Sites#5
Valencia, 46015
Italy3 sites
Almirall Investigational Sites#3
Cagliari, 09126
Almirall Investigational Sites#1
Genova, 16132
Almirall Investigational Sites#10
Pisa, 56124
About this study
Official title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.
- Being tested
- Aclidinium bromide 200 μg bid, Aclidinium bromide 400 μg bid, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, antimuscarinic, COPD
- 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 200 μg bidDrug
Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Aclidinium bromide 400 μg bidDrug
Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
PlaceboDrug
Placebo twice-daily by inhalation for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aclidinium bromide 200 μg bid | Experimental | Aclidinium bromide 200 μg twice-daily via inhalation Receives: Drug: Aclidinium bromide 200 μg bid |
| Aclidininum bromide 400 μg bid | Experimental | Aclidinium bromide 400 μg twice-daily via inhalation Receives: Drug: Aclidinium bromide 400 μg bid |
| 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 Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Measured: Baseline and Week 24
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment
Measured: Baseline and Week 12
Secondary outcomes (3)
Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Measured: Baseline and Week 24
Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment
Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment
Measured: Week 24
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment
Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2010
- Study completionNov 2010
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 828 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esther Garcia, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001494
- Sponsor's protocol ID
- M/34273/34
- Other IDs
- ATTAIN
- Status last verified
- Oct 2016
- First submitted
- 22 Oct 2009
- Last updated
- 4 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
PubMed 28074135Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.
PubMed 27215749Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.
PubMed 25234803Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. Epub 2012 Mar 22.
PubMed 22441743
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01001494
- Acronym / sponsor ID
- M/34273/34
- Keywords
- Chronic Obstructive Pulmonary Disease, antimuscarinic, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 828 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Posted 17 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aclidinium bromide 200 μg bid | Experimental | Drug: Aclidinium bromide 200 μg bidAclidinium bromide 200 μg twice-daily via inhalation |
| Aclidininum bromide 400 μg bid | Experimental | Drug: Aclidinium bromide 400 μg bidAclidinium bromide 400 μg twice-daily via inhalation |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
- Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
- Current or ex-smokers of ≥10 pack-years.
Key exclusion criteria (4 listed)
- Patients with no history or current diagnosis of asthma.
- No evidence of an exacerbation within 6 weeks prior to the screening visit.
- No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
- No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
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 200 μg bidAclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks | Drug | Aclidinium bromide 200 μg bid |
| Aclidinium bromide 400 μg bidAclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks | Drug | Aclidininum bromide 400 μg bid |
| PlaceboPlacebo twice-daily by inhalation for 24 weeks | Drug | Placebo |
Primary outcome
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Time frame: Baseline and Week 24
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment
Time frame: Baseline and Week 12
3 secondary outcomes
Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment
Time frame: Baseline and Week 24
Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment
Time frame: Week 24
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28074135McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
- Derived from this study: PubMed 27215749Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.
- Derived from this study: PubMed 25234803Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.
- Derived from this study: PubMed 22441743Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. Epub 2012 Mar 22.
- Almirall Corporate WebsiteLink provided by the sponsor.
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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.
Esther Garcia, MD study director
AstraZeneca
106 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aclidinium bromide 200 μg bid and Aclidinium bromide 400 μg bid in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 106 sites in 11 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 3 inclusion and 4 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in Poland, Germany, Hungary, South Africa, Russia and 6 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 17 Sep 2012). 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 Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (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 NCT01001494, 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 4 Jan 2017.