Pulmonary DiseaseNCT02446041
ICS/LABA Adherence and COPD Exacerbation
An observational study of Pulmonary Disease and Chronic Obstructive, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD patients who are adherent to the index medication and those who are non-adherent. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Non-Interventional Study
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Oct 2015
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICS/LABA patients with administrative claims data from health plans in the Northeast, Midwest, South and West United States.
Who may be able to join
- at least one prescription fill for ICS/LABA combination during identification period.
- COPD diagnosis
- 40 years or older at index date
- > or = 12 months of continuous health plan enrollment prior to and following index date
- 1 or more prescription for SABA, SAMA or SABA/SAMA during the pre-index period.
Who cannot join
- Patients with prescription claim for ICS/LABA combination therapy during the 12 month pre-index period
- Patients receiving oral corticosteroid medication for more than 180 days during the 12 month pre-index period
- Patients with cancer diagnosis in 12 month pre-index period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence and COPD Exacerbation Rates in Patients Initiating ICS/LABA Therapy.
The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD patients who are adherent to the index medication and those who are non-adherent.
Read the detailed description
This retrospective, observational study will assess the effectiveness of ICS/LABA combination therapies among COPD patients new to the ICS/LABA combination therapies in the US, comparing those who are adherent to the index medication and those who are non-adherent. Adherence will be measured using the proportion of days covered with the index medication. Medical and pharmacy claims data will be used as the data source.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Non-Interventional Study
- Keywords
- COPD, Chronic Bronchitis, Pulmonary Emphysema
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| ICS/LABA Patients | ICS/LABA Patients following standard of care Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation rate
Rate of COPD exacerbation occurring during the 12 months after therapy initiation.
Measured: 12 months
Secondary outcomes (1)
Severe Exacerbation rate
Severe exacerbation rate during the 12 months after therapy initiation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carelon Research
- Responsible party
- Sponsor
- Investigators
- Frank Trudo, MD, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446041
- Sponsor's protocol ID
- D589BR00034
- Status last verified
- Oct 2016
- First submitted
- 13 May 2015
- Last updated
- 11 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence and COPD Exacerbation Rates in Patients Initiating ICS/LABA Therapy.
- ClinicalTrials.gov ID
- NCT02446041
- Acronym / sponsor ID
- D589BR00034
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, Chronic Bronchitis, Pulmonary Emphysema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Carelon Research
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 May 2015 (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 retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD patients who are adherent to the index medication and those who are non-adherent.
Detailed description
This retrospective, observational study will assess the effectiveness of ICS/LABA combination therapies among COPD patients new to the ICS/LABA combination therapies in the US, comparing those who are adherent to the index medication and those who are non-adherent. Adherence will be measured using the proportion of days covered with the index medication. Medical and pharmacy claims data will be used as the data source.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICS/LABA Patients | – | Other: Non-Interventional StudyICS/LABA Patients following standard of care |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICS/LABA patients with administrative claims data from health plans in the Northeast, Midwest, South and West United States.
Key inclusion criteria (5 listed)
- at least one prescription fill for ICS/LABA combination during identification period.
- COPD diagnosis
- 40 years or older at index date
- > or = 12 months of continuous health plan enrollment prior to and following index date
- 1 or more prescription for SABA, SAMA or SABA/SAMA during the pre-index period.
Key exclusion criteria (3 listed)
- Patients with prescription claim for ICS/LABA combination therapy during the 12 month pre-index period
- Patients receiving oral corticosteroid medication for more than 180 days during the 12 month pre-index period
- Patients with cancer diagnosis in 12 month pre-index period
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 |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | ICS/LABA Patients |
Primary outcome
Exacerbation rate
Time frame: 12 months
Rate of COPD exacerbation occurring during the 12 months after therapy initiation.
1 secondary outcome
Severe Exacerbation rate
Time frame: 12 months
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 11 Oct 2016.
- 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.
Frank Trudo, MD study chair
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease and Chronic Obstructive, run by AstraZeneca at 1 site in United States.
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 5 inclusion and 3 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 11 Oct 2016. 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 United States. 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.
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?
Exacerbation rate (time frame: 12 months). 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 11 Oct 2016.