Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01462929

Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Aclidinium bromide and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 41 sites in 4 countries.

Completed

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

Official record

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Trial summary

The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment. 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 and Tiotropium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 414 participants
Where: 41 sitesin 4 countries
Study dates: Nov 2011to May 2012
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

41 sites in 4 countries.

Country

City, postcode or hospital

41 sites in 4 countries

Germany20 sites

Almirall Investigational Site #4
Berlin, 10117
Almirall Investigational Site #12
Berlin, 10717
Almirall Investigational Site #10
Berlin, 10969
Almirall Investigational Site #8
Berlin, 13125
Almirall Investigational Site #20
Berlin, 13507
Almirall Investigational Site #21
Berlin, 14050
Almirall Investigational Site #2
Berlin, 14057
Almirall Investigational Site #24
Cologne, 51069
Almirall Investigational Site #13
Dresden
Almirall Investigational Site #9
Frankfurt, 60596
Almirall Investigational Site #3
Großhansdorf, 22927
Almirall Investigational Site #1
Hamburg, 20253
Almirall Investigational Site #18
Hamburg, 22143
Almirall Investigational Site #5
Hanover, 30159
Almirall Investigational Site #22
Hanover, 30625
Almirall Investigational Site #14
Jena, 07740
Almirall Investigational Site #17
Lübeck, 23552
Almirall Investigational Site #23
Rüdersdorf, 15562
Almirall Investigational Site #6
Schwerin, 19055
Almirall Investigational Site #16
Wiesbaden, 65187

Other trials in Germany

Poland13 sites

Almirall Investigational Site #18
Bialystok, 15-540
Almirall Investigational Site #8
Bialystok, 15-540
Almirall Investigational Site #2
Elblag, 82-300
Almirall Investigational Site #17
Krakow, 31-023
Almirall Investigational Site #10
Krakow, 31-455
Almirall Investigational Site #16
Lodz, 90-153
Almirall Investigational Site #20
Lodz, 90-153
Almirall Investigational Site #4
Proszowice, 32-100
Almirall Investigational Site #6
Sopot, 84-741
Almirall Investigational Site #14
Tarnów, 33-100
Almirall Investigational Site #19
Warsaw, 01-138
Almirall Investigational Site #12
Wilkowice-Bystra, 43-365
Almirall Investigational Site #13
Wroclaw, 50-349

Other trials in Poland

Hungary5 sites

Almirall Investigational Site #4
Debrecen, 4043
Almirall Investigational Site #2
Komárom, 2900
Almirall Investigational Site #3
Mátraháza, 3233
Almirall Investigational Site #1
Szarvas, 5540
Almirall Investigational Site #11
Szigetszentmiklós, 2310

Other trials in Hungary

Czechia3 sites

Almirall Investigational Site #9
Humpolec, 396 26
Almirall Investigational Site #1
Jaroměř, 551 01
Almirall Investigational Site #3
Mělník, 276 01

Other trials in Czechia

About this study

Official title: A Multiple Dose, Double-blind, Double-dummy, Placebo Controlled, Parallel Clinical Trial to Assess the Efficacy and Safety of Twice Daily Inhaled Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Aclidinium bromide, Tiotropium, Placebo
Keywords: COPD, antimuscarinic
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 bromideDrug
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
TiotropiumDrug
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
PlaceboDrug
Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).

Study groups in NCT01462929
Study group	Role	What they receive
Aclidinium bromide	Experimental	Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment Receives: Drug: Aclidinium bromide
Tiotropium	Active comparator	Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment Receives: Drug: Tiotropium
Placebo	Placebo comparator	Placebo comparator administered during 6 weeks of treatment Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment
Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.
Measured: Week 6

Secondary outcomes (1)

Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment
Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.
Measured: Week 6

Timeline

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

Nov 2011May 2012

First posted1 Nov 2011 (estimated)
Study startNov 2011
Primary completionMar 2012
Study completionMay 2012

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 (1)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: 414 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01462929
Sponsor's protocol ID: M/34273/39
Status last verified: Nov 2016
First submitted: 28 Oct 2011
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 28074135

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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All Chronic Obstructive Pulmonary Disease (COPD) trials

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: A Multiple Dose, Double-blind, Double-dummy, Placebo Controlled, Parallel Clinical Trial to Assess the Efficacy and Safety of Twice Daily Inhaled Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01462929
Acronym / sponsor ID: M/34273/39
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, antimuscarinic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 414 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Mar 2012 (actual)
Study completion: May 2012 (actual)
First posted: 1 Nov 2011 (estimated)
Results: Posted 22 May 2013

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: 3

Arm	Type	Receives
Aclidinium bromide	Experimental	Drug: Aclidinium bromideAclidinium bromide 400 µg administered twice per day during 6 weeks of treatment
Tiotropium	Active comparator	Drug: TiotropiumTiotropium bromide 18 µg administered once per day during 6 weeks of treatment
Placebo	Placebo comparator	Drug: PlaceboPlacebo comparator administered during 6 weeks of treatment

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 bromideDosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)	Drug	Aclidinium bromide
TiotropiumDosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)	Drug	Tiotropium
PlaceboDosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).	Drug	Placebo

Primary outcome

Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment
Time frame: Week 6
Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.

1 secondary outcome

Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment
Time frame: Week 6

Results and safety

Results posted to the registry on 22 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aclidinium Bromide 400 µg BID	171	166
Tiotropium 18 μg Once-daily	158	154
Placebo	85	80

Primary outcome: Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment

Time frame: Week 6. Least squares mean (Standard Error). Unit: Liters

Measure	Aclidinium Bromide 400 µg BID n = 170	Tiotropium 18 μg Once-daily n = 158	Placebo n = 85
Value	0.065 (0.017)	0.055 (0.018)	-0.085 (0.023)

Population analysed: Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aclidinium Bromide 400 µg BID	3 of 171 (1.8%)	16 of 171 (9.4%)	Not reported
Tiotropium 18 μg Once-daily	4 of 158 (2.5%)	17 of 158 (10.8%)	Not reported
Placebo	0 of 85 (0%)	6 of 85 (7.1%)	Not reported

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.
CSR SynopsisLink provided by the sponsor.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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, Ph.D. study director

AstraZeneca

41 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium bromide and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 41 sites in 4 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 41 sites in Germany, Poland, Hungary, Czechia. 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 22 May 2013). 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 Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment (time frame: Week 6). 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 NCT01462929, which also lists 1 linked publication.

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.