Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01471171

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

A Phase 3 study testing Aclidinium Bromide in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 14 sites in 3 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 effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 112 participants
Where: 14 sitesin 3 countries
Study dates: Nov 2011to Jun 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 (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%.
Current or ex-smokers of ≥ 10 pack-years
Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Who cannot join

History or current diagnosis of asthma
Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Patients with an oxygen saturation < 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
Contra-indications of cardiopulmonary exercise testing.
Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.

Trial locations and contacts

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

Germany10 sites

Almirall Investigational Site #10
Berlin, 10117
Almirall Investigational Site #6
Berlin, 10117
Almirall Investigational Site #2
Berlin, 14050
Almirall Investigational Site #4
Frankfurt, 60596
Almirall Investigational Site #5
Großhansdorf, 22927
Almirall Investigational Site #8
Hamburg, 20354
Almirall Investigational Site #9
Hamburg, 22335
Almirall Investigational Site #3
Hanover, 30625
Almirall Investigational Site #7
Lübeck, 23552
Almirall Investigational Site #1
Wiesbaden, 65187

Other trials in Germany

Spain3 sites

Almirall Investigational Site #1
Alicante, 03114
Almirall Investigational Site #4
Barcelona, 08003
Almirall Investigational Site #2
Madrid, 28007

Other trials in Spain

United Kingdom1 site

Almirall Investigational Site #2
London, W1G 8HU

Other trials in United Kingdom

About this study

Official title: A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Aclidinium Bromide, 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
1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
PlaceboDrug
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)

Study groups in NCT01471171
Study group	Role	What they receive
Aclidinium bromide	Experimental	3-week treatment periods Receives: Drug: Aclidinium Bromide
Placebo	Experimental	3-week treatment periods Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Endurance Time (Seconds)
Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.
Measured: Week 3

Secondary outcomes (2)

Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)
Change from baseline in trough IC after 3 weeks of treatment
Measured: Week 3
Change From Baseline in Intensity of Dyspnoea
Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.
Measured: Week 3

Timeline

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

Nov 2011Jun 2012

First posted15 Nov 2011 (estimated)
Study startNov 2011
Primary completionJun 2012
Study completionJun 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01471171
Sponsor's protocol ID: M/34273/40
Status last verified: Oct 2016
First submitted: 10 Nov 2011
Last updated: 4 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Beeh KM, Watz H, Puente-Maestu L, de Teresa L, Jarreta D, Caracta C, Garcia Gil E, Magnussen H. Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial. BMC Pulm Med. 2014 Dec 23;14:209. doi: 10.1186/1471-2466-14-209.
PubMed 25539654

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

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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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01471171
Acronym / sponsor ID: M/34273/40
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, Antimuscarinic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 15 Nov 2011 (estimated)
Results: Posted 30 Jul 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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Aclidinium bromide	Experimental	Drug: Aclidinium Bromide3-week treatment periods
Placebo	Experimental	Drug: Placebo3-week treatment periods

Who may qualify

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

Key inclusion criteria (4 listed)

Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%.
Current or ex-smokers of ≥ 10 pack-years
Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Key exclusion criteria (7 listed)

History or current diagnosis of asthma
Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Patients with an oxygen saturation < 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.

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 Bromide1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)	Drug	Aclidinium bromide
Placebo1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)	Drug	Placebo

Primary outcome

Change From Baseline in Endurance Time (Seconds)
Time frame: Week 3
Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.

2 secondary outcomes

Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)
Time frame: Week 3
Change From Baseline in Intensity of Dyspnoea
Time frame: Week 3

Results and safety

Results posted to the registry on 30 Jul 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 - Placebo	57	53
Placebo - Aclidinium Bromide 400 μg	55	54

Primary outcome: Change From Baseline in Endurance Time (Seconds)

Time frame: Week 3. Least squares mean (Standard Error). Unit: Seconds

Measure	Aclidinium Bromide 400 μg Bid n = 109	Placebo n = 107
Value	68.3 (18.8)	9.8 (19.0)

Population analysed: Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aclidinium Bromide 400 μg Bid	0 of 111 (0%)	7 of 111 (6.3%)	Not reported
Placebo	2 of 108 (1.9%)	4 of 108 (3.7%)	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 25539654Beeh KM, Watz H, Puente-Maestu L, de Teresa L, Jarreta D, Caracta C, Garcia Gil E, Magnussen H. Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial. BMC Pulm Med. 2014 Dec 23;14:209. doi: 10.1186/1471-2466-14-209.
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
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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

14 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aclidinium Bromide in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 14 sites in 3 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 4 inclusion and 7 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 14 sites in Germany, Spain, United Kingdom. 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. 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 30 Jul 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 Endurance Time (Seconds) (time frame: Week 3). 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 NCT01471171, 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.