Chronic Obstructive Pulmonary DiseasePhase 2ALIGHT-COPDNCT01078623
Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate
A Phase 2 study testing Aclidinium 200 μg / formoterol 12 μg, Formoterol 12 μg and Aclidinium 200 μg in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 10 sites in 2 countries.
Trial summary
The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Aclidinium 200 μg / formoterol 12 μg, Formoterol 12 μg and Aclidinium 200 μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Feb 2010to Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.
- Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification
- 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 400 mcg 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%).
- Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
- Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.
- Patient whose COPD symptoms and FEV1 values at the time of randomisation are stable compared to the Screening Visit, according to the investigator's medical judgment
Who cannot join
- History or current diagnosis of asthma or exercise-induced bronchospasm.
- Clinically significant respiratory conditions 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.
- Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.
- Clinically significant cardiovascular conditions
Show all 10Show fewer
- Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
- Presence of narrow-angle glaucoma.
- QTc [calculated according to Bazett's formulae (QTc=QT/RR1/2) 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
10 sites in 2 countries.
10 sites in 2 countries
Romania6 sites
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Deva
Research Site
Iași
Research Site
Oradea
Research Site
Timișoara
Czechia4 sites
Research Site
Bucuresti
Research Site
Constanta
Research Site
Iasi
Research Site
Tg Mures
About this study
Official title: Efficacy, Safety and Tolerability of Two Fixed-Dose Combinations of Aclidinium Bromide With Two Doses of Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo All Administered Twice Daily in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease Patients.
The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.
Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Aclidinium 200 μg / formoterol 12 μg, Placebo, Formoterol 12 μg, Aclidinium 200 μg, Aclidinium 200 μg / Formoterol 6 μg
- Keywords
- Bronchitis, Chronic, Emphysema
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Bronchiolitis Obliterans Syndrome, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aclidinium 200 μg / formoterol 12 μgDrug
Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily
PlaceboDrug
Placebo control twice daily
Formoterol 12 μgDrug
Formoterol fumarate 12 μg twice daily
Aclidinium 200 μgDrug
Aclidinium bromide 200 μg twice daily
Aclidinium 200 μg / Formoterol 6 μgDrug
Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Formoterol 12 μg | Active comparator | Formoterol fumarate 12 μg twice daily Receives: Drug: Formoterol 12 μg |
| Placebo | Placebo comparator | Placebo twice daily Receives: Drug: Placebo |
| Aclidinium 200 μg / formoterol 12 μg | Experimental | Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily Receives: Drug: Aclidinium 200 μg / formoterol 12 μg |
| Aclidinium 200 μg / formoterol 6 μg | Experimental | Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily Receives: Drug: Aclidinium 200 μg / Formoterol 6 μg |
| Aclidinium 200 μg | Experimental | Aclidinium bromide 200 μg twice daily Receives: Drug: Aclidinium 200 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
Measured: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
Secondary outcomes (2)
Change From Baseline in Morning Pre-dose FEV1 at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes
Measured: Day 14
Change From Baseline in Morning Peak FEV1 at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
Measured: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2010
- Study completionSep 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.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 176 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
- NCT01078623
- Sponsor's protocol ID
- M/40464/26
- Acronym
- ALIGHT-COPD
- Status last verified
- Dec 2016
- First submitted
- 1 Mar 2010
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of Two Fixed-Dose Combinations of Aclidinium Bromide With Two Doses of Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo All Administered Twice Daily in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease Patients.
- ClinicalTrials.gov ID
- NCT01078623
- Acronym / sponsor ID
- ALIGHT-COPD / M/40464/26
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Bronchitis, Chronic, Emphysema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Posted 15 Nov 2016
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 multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD.
Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 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 |
|---|---|---|
| Formoterol 12 μg | Active comparator | Drug: Formoterol 12 μgFormoterol fumarate 12 μg twice daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice daily |
| Aclidinium 200 μg / formoterol 12 μg | Experimental | Drug: Aclidinium 200 μg / formoterol 12 μgAclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily |
| Aclidinium 200 μg / formoterol 6 μg | Experimental | Drug: Aclidinium 200 μg / Formoterol 6 μgAclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily |
| Aclidinium 200 μg | Experimental | Drug: Aclidinium 200 μgAclidinium bromide 200 μg twice daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive.
- Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification
- 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 400 mcg 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%).
- Patient whose FEV1/FVC at the Screening Visit measured between 10-15 minutes post inhalation of 400 mcg of salbutamol is < 70% (i.e., 100 x Post-salbutamol FEV1 /FVC < 70%).
Key exclusion criteria (10 listed)
- History or current diagnosis of asthma or exercise-induced bronchospasm.
- Clinically significant respiratory conditions 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.
- Patient who has a resting systolic blood pressure ≥ 200 mmHg, a resting diastolic blood pressure ≥ 120 mmHg or a resting heart rate ≥ 105 bpm at screening visit.
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 200 μg / formoterol 12 μgAclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily | Drug | Aclidinium 200 μg / formoterol 12 μg |
| PlaceboPlacebo control twice daily | Drug | Placebo |
| Formoterol 12 μgFormoterol fumarate 12 μg twice daily | Drug | Formoterol 12 μg |
| Aclidinium 200 μgAclidinium bromide 200 μg twice daily | Drug | Aclidinium 200 μg |
| Aclidinium 200 μg / Formoterol 6 μgAclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily | Drug | Aclidinium 200 μg / formoterol 6 μg |
Primary outcome
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14
Time frame: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
2 secondary outcomes
Change From Baseline in Morning Pre-dose FEV1 at Day 14
Time frame: Day 14
Change From Baseline in Morning Peak FEV1 at Day 14
Time frame: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
10 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 200 μg / formoterol 12 μg, Formoterol 12 μg and Aclidinium 200 μg in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 10 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 7 inclusion and 10 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Romania, 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 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 15 Nov 2016). 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 Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14 (time frame: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.