Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT01120093
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
A Phase 2 study testing Aclidinium bromide 100 μg bid, Aclidinium bromide 200 μg bid and Aclidininum bromide 400 μg bid in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 11 sites in 2 countries.
Trial summary
The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary… 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 100 μg bid, Aclidinium bromide 200 μg bid and Aclidininum bromide 400 μg bid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 11 sitesin 2 countries
- Study dates
- May 2010to Aug 2010
- Phase
- Phase 2
- 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
- Males and non-pregnant, non-lactating females aged ≥ 40.
- Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).
- Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
- Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation 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%).
- Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.
- Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.
Who cannot join
- History or current diagnosis of asthma.
- Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature
- Hospitalisation due to COPD exacerbation within the previous 3 months.
- Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
- Clinically significant cardiovascular conditions
- Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
Show all 9Show fewer
- Presence of narrow-angle glaucoma.
- QTcB) above 470 milliseconds in the ECG performed at Screening Visit,
- Patient who does not maintain regular day/night, waking/sleeping cycles
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Germany10 sites
Almirall Investigational Sites#3
Berlin, 10117
Almirall Investigational Sites#4
Berlin, 13125
Almirall Investigational Sites#9
Berlin, 14050
Almirall Investigational Sites#8
Frankfurt, 60596
Almirall Investigational Sites#1
Groβhansdorf, 22927
Almirall Investigational Sites#5
Hamburg, 20249
Almirall Investigational Sites#7
Hanover, 30159
Almirall Investigational Sites#2
Hanover, 30625
Almirall Investigational Sites#6
Schwerin, 19055
Almirall Investigational Sites#10
Wiesbaden, 65187
About this study
Official title: Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator All Administered Twice Daily by Inhalation in Patients With Stable Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD).
The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
- Being tested
- Aclidinium bromide 100 μg bid, Aclidinium bromide 200 μg bid, Aclidininum bromide 400 μg bid, Placebo, Formoterol 12 μg bid
- Keywords
- 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 100 μg bidDrug
Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Aclidinium bromide 200 μg bidDrug
Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Aclidininum bromide 400 μg bidDrug
Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
PlaceboDrug
Placebo via inhalation in the morning and evening for 7 days
Formoterol 12 μg bidDrug
Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Aclidinium bromide 100 μg bid | Experimental | Aclidininum bromide 100 μg twice daily by inhalation Receives: Drug: Aclidinium bromide 100 μg bid |
| Aclidininum bromide 200 μg bid | Experimental | Aclidininum bromide 200 μg twice daily by inhalation Receives: Drug: Aclidinium bromide 200 μg bid |
| Aclidininum bromide 400 μg bid | Experimental | Aclidininum bromide 400 μg twice daily by inhalation Receives: Drug: Aclidininum bromide 400 μg bid |
| Placebo | Placebo comparator | Placebo twice-daily by inhalation Receives: Drug: Placebo |
| Formoterol 12 μg bid | Active comparator | Formoterol 12 μg twice daily by inhalation Receives: Drug: Formoterol 12 μg bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment
Measured: Day 7
Secondary outcomes (3)
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment
Measured: Day 7
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment
Measured: Day 7
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionAug 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 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 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
- NCT01120093
- Sponsor's protocol ID
- M/34273/29
- Other IDs
- LAS29
- Status last verified
- Nov 2016
- First submitted
- 7 May 2010
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther. 2012 Jun;25(3):248-53. doi: 10.1016/j.pupt.2012.03.008. Epub 2012 Apr 4.
PubMed 22497752
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator All Administered Twice Daily by Inhalation in Patients With Stable Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT01120093
- Acronym / sponsor ID
- M/34273/29
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Posted 12 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 present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Aclidinium bromide 100 μg bid | Experimental | Drug: Aclidinium bromide 100 μg bidAclidininum bromide 100 μg twice daily by inhalation |
| Aclidininum bromide 200 μg bid | Experimental | Drug: Aclidinium bromide 200 μg bidAclidininum bromide 200 μg twice daily by inhalation |
| Aclidininum bromide 400 μg bid | Experimental | Drug: Aclidininum bromide 400 μg bidAclidininum bromide 400 μg twice daily by inhalation |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice-daily by inhalation |
| Formoterol 12 μg bid | Active comparator | Drug: Formoterol 12 μg bidFormoterol 12 μg twice daily by inhalation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and non-pregnant, non-lactating females aged ≥ 40.
- Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC < 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC <70%).
- Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
- Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation 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%).
- Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.
Key exclusion criteria (9 listed)
- History or current diagnosis of asthma.
- Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature
- Hospitalisation due to COPD exacerbation within the previous 3 months.
- Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
- Clinically significant cardiovascular conditions
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 100 μg bidAclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days | Drug | Aclidinium bromide 100 μg bid |
| Aclidinium bromide 200 μg bidAclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days | Drug | Aclidininum bromide 200 μg bid |
| Aclidininum bromide 400 μg bidAclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days | Drug | Aclidininum bromide 400 μg bid |
| PlaceboPlacebo via inhalation in the morning and evening for 7 days | Drug | Placebo |
| Formoterol 12 μg bidFormoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days | Drug | Formoterol 12 μg bid |
Primary outcome
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment
Time frame: Day 7
3 secondary outcomes
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment
Time frame: Day 7
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment
Time frame: Day 7
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22497752Singh D, Magnussen H, Kirsten A, Mindt S, Caracta C, Seoane B, Jarreta D, Garcia Gil E. A randomised, placebo- and active-controlled dose-finding study of aclidinium bromide administered twice a day in COPD patients. Pulm Pharmacol Ther. 2012 Jun;25(3):248-53. doi: 10.1016/j.pupt.2012.03.008. Epub 2012 Apr 4.
- Almirall Corporate WebsiteLink provided by the sponsor.
- CSR SynopsisLink 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
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aclidinium bromide 100 μg bid, Aclidinium bromide 200 μg bid and Aclidininum bromide 400 μg bid in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 11 sites in 2 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 6 inclusion and 9 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 9 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 11 sites in Germany, Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 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 Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment (time frame: Day 7). 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 NCT01120093, 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 9 Jan 2017.