Chronic Obstructive Pulmonary DiseasePhase 4ASTUTENCT03181880
To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Aclidinium bromide/formoterol fumarate combination in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca.
Trial summary
ASTUTE is a pragmatic open randomised 12-week multinational trial to evaluate the effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination compared to standard of care bronchodilators in chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Aclidinium bromide/formoterol fumarate combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2017to 3 Dec 2018
- Phase
- Phase 4
- 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
- Patient is aged 40 years or older;
- Confirmed diagnosis of COPD;
- Spirometry performed at study entry or within the last 3 months preceding study entry with a post-bronchodilator Forced Expiratory Volume in 1 Second/Forced Vital Capacity quotient less than 0.7;
- Patient is a current smoker or an ex-smoker with a smoking history of ≥10 pack-years;
- Patient belongs to any of these treatment groups:
- Patient is treated by a monotherapy long-acting bronchodilator (Long-Acting Muscarinic Antagonist or Long-Acting Beta Agonist), or
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- Naïve COPD patient, defined as:
- Patient is newly diagnosed, or
- Patient is naïve to maintenance therapy, or
- Patient is treated with short acting bronchodilators as rescue medication, or
- Patient has not been treated with long acting bronchodilators in the last 3 months.
Who cannot join
- -
- Patients should not be included in the study if any of the following exclusion criteria applies:
- Patient changed COPD treatment regimen over the preceding 3 months;
- Patient treated or intended to be treated at the time of randomisation with a maintenance regimen of inhaled corticosteroids or inhaled corticosteroids-containing medications;
- Patient treated or intended to be treated at the time of randomisation with aclidinium bromide/formoterol fumarate dihydrate inhalation powder;
- Patient had a previous diagnosis of asthma or is suspected of having asthma, asthma-COPD overlap or any other chronic respiratory disease other than COPD (including severe ones, such as cystic fibrosis, pulmonary fibrosis, active neoplasm except adequately treated [no evidence of recurrence within 5 years], active tuberculosis);
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- Patient developed a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if an exacerbation-related hospitalisation was required) before the randomisation visit;
- Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, lactose monohydrate, inhaled medication, or any component thereof (including report of paradoxical bronchospasm);
- Patient has been previously enrolled in the current study.
- Any condition that in the Investigator's opinion, would limit a patient's ability to participate in the study.
About this study
ASTUTE is a pragmatic open randomised 12-week multinational trial to evaluate the effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination compared to standard of care bronchodilators in chronic obstructive pulmonary disease.
Read the detailed description
ASTUTE is a longitudinal, randomised, multicentre, and multinational pragmatic study of patients with Chronic Obstructive Pulmonary Disease to evaluate the comparative effectiveness of Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®) and Standard of Care bronchodilators in patients treated with long acting bronchodilator monotherapies OR patients who abide to the following treatment category: patient is newly diagnosed, or naïve to maintenance therapy, or treated with short-acting bronchodilators as rescue medication, or has not been treated with long-acting bronchodilators in the last 3 months.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Aclidinium bromide/formoterol fumarate combination, Standard of Care
- Keywords
- ASTUTE, Chronic Obstructive Pulmonary Disease, Randomised, Pragmatic, Standard of Care, Aclidinium bromide/formoterol fumarate fixed-dose combination, Duaklir, Genuair
- 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/formoterol fumarate combinationDrug
Also called Duaklir™ Genuair®
Patients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®), or Standard Of Care (SOC) Bronchodilators.
The product in study is Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®).
Each inhaler will contain at least 60 doses (and a maximum of 68 doses) of aclidinium bromide/formoterol fixed-dose combination 400μg /12μg. Patients will be instructed to take 1 puff in the morning (09:00 ± 1 h) and 1 puff in the evening (21:00 ± 1 h) during the 12 weeks of treatment.
Standard of CareDrug
Brochodilators
| Study group | Role | What they receive |
|---|---|---|
| Aclidinium/formoterol | Active comparator | Patients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination Receives: Drug: Aclidinium bromide/formoterol fumarate combination |
| Bronchodilators | Active comparator | The comparator arm consists of SOC. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in overall early morning COPD symptom severity score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder vs. Standard of Care bronchodilators as measured by the Early Morning Symptoms of COPD Instrument over 12 wks.
Changes from baseline compared between aclidinium bromide/formoterol fumarate dihydrate inhalation powder and Standard of Care bronchodilators. Baseline values for EMSCI will be averaged over the study entry and previous day. For longitudinal analyses, each daily measure will be aggregated on a weekly (7 days) basis during the weeks of measurement (weeks 4, 8, and/or 12) by taking the mean value of all available measurements during the week.
Measured: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84
Change from baseline in overall night time COPD symptom severity score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder vs. Standard of Care bronchodilators as measured by the Nighttime Symptoms of COPD Instrument over 12 weeks.
Changes from baseline compared between aclidinium bromide/formoterol fumarate dihydrate inhalation powder and Standard of Care bronchodilators. Baseline values for NiSCI will be averaged over the study entry and previous day. For longitudinal analyses, each daily measure will be aggregated on a weekly (7 days) basis during the weeks of measurement (weeks 4, 8, and/or 12) by taking the mean value of all available measurements during the week.
Measured: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84
Secondary outcomes (5)
Change from baseline in daily RS total Score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the E-RS™COPD scale over 12 weeks.
Baseline values of the RS-Total Score will be collected and averaged at the study entry visit and previous day.
The secondary effectiveness variable will be estimated by the change from baseline in daily RS-Total Score over 12 weeks of treatment.
Measured: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84
Change from baseline in health status of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilatorsmeasured by the COPD assessment Test (CAT) over 12 weeks.
The CAT measures the health status of patients with COPD. If the response to 1 of the 8 items is missing, the score will be considered missing. Change from baseline in health status over 12 weeks of follow-up (on the last day of weeks 4, 8, and 12) will be calculated. These change scores will be the CAT endpoint.
Measured: study entry, days 28, 56 and 84
Change from baseline in total time index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.
The Total Time Index will be calculated at baseline and over 12 weeks of follow-up (on the last day of weeks 4, 8, and 12). Change from baseline will be calculated. These change scores will be the Total Time Index analysed.
Measured: study entry, days 28, 56 and 84
Change from baseline in Energy Expenditure Index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.
The Energy Expenditure Index will be calculated at baseline and over 12 weeks of follow-up (on the last day of weeks 4, 8, and 12). Change from baseline will be calculated. These change scores will be the Energy Expenditure Index analysed.
Measured: study entry, days 28, 56 and 84
Change from baseline in Activity Dimensions Summary Index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.
The Activity Dimensions Summary Index will be calculated at baseline and over 12 weeks of follow-up (on the last day of weeks 4, 8, and 12). Change from baseline will be calculated. These change scores will be the Activity Dimensions Summary Index analysed.
Measured: study entry, days 28, 56 and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start4 Dec 2017 (estimated)
- Primary completion3 Dec 2018 (estimated)
- Study completion3 Dec 2018 (estimated)
Why it stopped: Study stopped early as AZ have re-prioritised to focus on research to help bring existing and innovative medicines to more patients with asthma and COPD.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QuintilesIMS, Inc.
- Responsible party
- Sponsor
- Investigators
- Anna Ribera, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181880
- Sponsor's protocol ID
- D6570R00004
- Acronym
- ASTUTE
- Status last verified
- Jun 2017
- First submitted
- 26 Apr 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03181880
- Acronym / sponsor ID
- ASTUTE / D6570R00004
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- ASTUTE, Chronic Obstructive Pulmonary Disease, Randomised, Pragmatic, Standard of Care, Aclidinium bromide/formoterol fumarate fixed-dose combination, Duaklir, Genuair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped early as AZ have re-prioritised to focus on research to help bring existing and innovative medicines to more patients with asthma and COPD.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- QuintilesIMS, Inc.
- Study start
- 4 Dec 2017 (estimated)
- Primary completion
- 3 Dec 2018 (estimated)
- Study completion
- 3 Dec 2018 (estimated)
- First posted
- 9 Jun 2017 (actual)
- 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.
ASTUTE is a pragmatic open randomised 12-week multinational trial to evaluate the effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination compared to standard of care bronchodilators in chronic obstructive pulmonary disease.
Detailed description
ASTUTE is a longitudinal, randomised, multicentre, and multinational pragmatic study of patients with Chronic Obstructive Pulmonary Disease to evaluate the comparative effectiveness of Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®) and Standard of Care bronchodilators in patients treated with long acting bronchodilator monotherapies OR patients who abide to the following treatment category: patient is newly diagnosed, or naïve to maintenance therapy, or treated with short-acting bronchodilators as rescue medication, or has not been treated with long-acting bronchodilators in the last 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aclidinium/formoterol | Active comparator | Drug: Aclidinium bromide/formoterol fumarate combinationPatients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination |
| Bronchodilators | Active comparator | Drug: Standard of CareThe comparator arm consists of SOC. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is aged 40 years or older;
- Confirmed diagnosis of COPD;
- Spirometry performed at study entry or within the last 3 months preceding study entry with a post-bronchodilator Forced Expiratory Volume in 1 Second/Forced Vital Capacity quotient less than 0.7;
- Patient is a current smoker or an ex-smoker with a smoking history of ≥10 pack-years;
- Patient belongs to any of these treatment groups:
Key exclusion criteria (10 listed)
- -
- Patients should not be included in the study if any of the following exclusion criteria applies:
- Patient changed COPD treatment regimen over the preceding 3 months;
- Patient treated or intended to be treated at the time of randomisation with a maintenance regimen of inhaled corticosteroids or inhaled corticosteroids-containing medications;
- Patient treated or intended to be treated at the time of randomisation with aclidinium bromide/formoterol fumarate dihydrate inhalation powder;
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/formoterol fumarate combinationAlso: Duaklir™ Genuair®Patients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®), or Standard Of Care (SOC) Bronchodilators. The product in study is Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®). Each inhaler will contain at least 60 doses (and a maximum of 68 doses) of aclidinium bromide/formoterol fixed-dose combination 400μg /12μg. Patients will be instructed to take 1 puff in the morning (09:00 ± 1 h) and 1 puff in the evening (21:00 ± 1 h) during the 12 weeks of treatment. | Drug | Aclidinium/formoterol |
| Standard of CareBrochodilators | Drug | Bronchodilators |
Primary outcome
Change from baseline in overall early morning COPD symptom severity score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder vs. Standard of Care bronchodilators as measured by the Early Morning Symptoms of COPD Instrument over 12 wks.
Time frame: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84
Changes from baseline compared between aclidinium bromide/formoterol fumarate dihydrate inhalation powder and Standard of Care bronchodilators. Baseline values for EMSCI will be averaged over the study entry and previous day. For longitudinal analyses, each daily measure will be aggregated on a weekly (7 days) basis during the weeks of measurement (weeks 4, 8, and/or 12) by taking the mean value of all available measurements during the week.
Change from baseline in overall night time COPD symptom severity score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder vs. Standard of Care bronchodilators as measured by the Nighttime Symptoms of COPD Instrument over 12 weeks.
Time frame: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84
Changes from baseline compared between aclidinium bromide/formoterol fumarate dihydrate inhalation powder and Standard of Care bronchodilators. Baseline values for NiSCI will be averaged over the study entry and previous day. For longitudinal analyses, each daily measure will be aggregated on a weekly (7 days) basis during the weeks of measurement (weeks 4, 8, and/or 12) by taking the mean value of all available measurements during the week.
5 secondary outcomes
Change from baseline in daily RS total Score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the E-RS™COPD scale over 12 weeks.
Time frame: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84
Change from baseline in health status of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilatorsmeasured by the COPD assessment Test (CAT) over 12 weeks.
Time frame: study entry, days 28, 56 and 84
Change from baseline in total time index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.
Time frame: study entry, days 28, 56 and 84
Change from baseline in Energy Expenditure Index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.
Time frame: study entry, days 28, 56 and 84
Change from baseline in Activity Dimensions Summary Index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.
Time frame: study entry, days 28, 56 and 84
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Anna Ribera study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aclidinium bromide/formoterol fumarate combination in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca.
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 11 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: withdrawn, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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 overall early morning COPD symptom severity score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder vs. Standard of Care bronchodilators as measured by the Early Morning Symptoms of COPD Instrument over 12 wks. (time frame: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84). The study lists 2 primary outcomes in all. 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 2 Jul 2017.