COPDPhase 3NCT01636401
Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing aclidinium bromide 400 μg in people with COPD, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- aclidinium bromide 400 μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 ≥ 30% to <80% of the predicted value.
- Current or former cigarette smokers with a smoking history of at least 10 pack-years.
Who cannot join
- History or current diagnosis of asthma
- Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1
- Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1.
- Patients with any clinically significant respiratory conditions other than COPD
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD).
- Conditions
- COPD
- Being tested
- aclidinium bromide 400 μg, aclidinium bromide placebo
- 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 400 μgDrug
aclidinium bromide placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| aclidinium bromide | Active comparator | Not described Receives: Drug: aclidinium bromide 400 μg |
| Placebo | Placebo comparator | Not described Receives: Drug: aclidinium bromide placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 12 in morning predose (trough) FEV1
Measured: Week 12
Secondary outcomes (1)
Change from baseline to Week 12 in peak FEV1
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636401
- Sponsor's protocol ID
- DW_EKL001
- Status last verified
- Aug 2013
- First submitted
- 6 Jul 2012
- Last updated
- 21 Aug 2013
- Results posted
- No
Publications
Lee SH, Lee J, Yoo KH, Uh ST, Park MJ, Lee SY, Kim JY, Kim DK, Kim SJ, Lee KH, Yoo CG. Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population. Respirology. 2015 Nov;20(8):1222-8. doi: 10.1111/resp.12641. Epub 2015 Sep 15.
PubMed 26370136
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01636401
- Acronym / sponsor ID
- DW_EKL001
- Conditions
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to observe the Efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aclidinium bromide | Active comparator | Drug: aclidinium bromide 400 μg |
| Placebo | Placebo comparator | Drug: aclidinium bromide placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of stable moderate to severe COPD as defined by GOLD (the Global Initiative for Chronic Obstructive Lung Disease) guidelines(http://www.goldcopd.org); a postbronchodilator FEV1/forced vital capacity [FVC] ratio < 70% and FEV1 ≥ 30% to <80% of the predicted value.
- Current or former cigarette smokers with a smoking history of at least 10 pack-years.
Key exclusion criteria (4 listed)
- History or current diagnosis of asthma
- Patients who have been hospitalized for an acute COPD exacerbation within 3 months prior to Visit 1
- Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks before Visit 1.
- Patients with any clinically significant respiratory conditions other than COPD
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 400 μg | Drug | aclidinium bromide |
| aclidinium bromide placebo | Drug | Placebo |
Primary outcome
Change from baseline to Week 12 in morning predose (trough) FEV1
Time frame: Week 12
1 secondary outcome
Change from baseline to Week 12 in peak FEV1
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
- Derived from this study: PubMed 26370136Lee SH, Lee J, Yoo KH, Uh ST, Park MJ, Lee SY, Kim JY, Kim DK, Kim SJ, Lee KH, Yoo CG. Efficacy and safety of aclidinium bromide in patients with COPD: A phase 3 randomized clinical trial in a Korean population. Respirology. 2015 Nov;20(8):1222-8. doi: 10.1111/resp.12641. Epub 2015 Sep 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aclidinium bromide 400 μg in people with COPD, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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 2 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 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 to Week 12 in morning predose (trough) FEV1 (time frame: Week 12). 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 NCT01636401, 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 21 Aug 2013.