COPDAIREICNCT07059273
A COPD Data Registry for Participants With Frequent Exacerbations
An observational study of COPD, run by Hoffmann-La Roche.
Trial summary
This registry will collect data on COPD, including the course of disease, treatment patterns, and potential new therapies. The registry will also track the experience of participants and caregivers in clinical practice. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2026to 1 May 2031
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants at least 40 years of age that have had a COPD diagnosis for at least 12 months, are on stable maintenance therapy, and who have experienced at least two exacerbations in the last 12 months.
Who may be able to join
- Diagnosis of COPD for at least 12 months
- On stable, standard of care (SoC) COPD maintenance therapy
- Have experienced at least 2 exacerbations (moderate or severe) in the last 12 months, with one of them occurring while on SoC therapy
Who cannot join
- In palliative treatment
- Participating in any interventional drug trials
About this study
Official title: An Observational, Prospective, Real-world Data Registry in Chronic Obstructive Pulmonary Disease (COPD) Patients Suffering From Frequent Exacerbations (AIREIC)
This registry will collect data on COPD, including the course of disease, treatment patterns, and potential new therapies. The registry will also track the experience of participants and caregivers in clinical practice.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD Arm | Participants with COPD with frequent exacerbations will be followed from the date of enrollment until death, loss to follow up, withdrawal of consent, or the end of the follow-up period, for up to 3 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease course of participants enrolled in COPD registry
Measured: Up to 3 years
Treatment patterns of participants enrolled in COPD registry
Treatment patterns of participants enrolled in COPD registry would be monitored through medical records and the changes in the standard of care and potentially moving to other treatments such as biologics.
Measured: Up to 3 years
Number of novel therapies for participants enrolled in COPD registry
Through medical records, the number and type of novel therapies would be assessed for participants enrolled in COPD registry.
Measured: Up to 3 years
Health care utilization (HCU) by participants enrolled in COPD registry as measured by number of medical visits
Measured: Up to 3 years
HCU by participants enrolled in COPD registry as measured by types of medical care institutions visited
Measured: Up to 3 years
Quality of life (QoL) of participants enrolled in COPD registry as measured by the Chronic Airways Assessment Test (CAAT)
Measured: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the EQ-5D Five Levels plus respiratory dimension (EQ-5D-5L+R) questionnaire
Measured: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the Work Productivity and Impairment (WPAI)-COPD
Measured: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the COPD treatment satisfaction questionnaire
Measured: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the exacerbation experience questionnaire
Measured: Up to 3 years
Caregiver burden as measured by the Zarit Burden Interview 12-item (ZBI-12)
Measured: Up to 3 years
Caregiver burden as measured by the Work Productivity and Impairment (WPAI) questionnaire
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start14 Sep 2026 (estimated)
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2031 (estimated)
Why it stopped: The study was withdrawn due to a business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059273
- Sponsor's protocol ID
- BA45495
- Acronym
- AIREIC
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2025
- Last updated
- 22 Jun 2026
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective, Real-world Data Registry in Chronic Obstructive Pulmonary Disease (COPD) Patients Suffering From Frequent Exacerbations (AIREIC)
- ClinicalTrials.gov ID
- NCT07059273
- Acronym / sponsor ID
- AIREIC / BA45495
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to a business decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 10 Jul 2025 (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.
This registry will collect data on COPD, including the course of disease, treatment patterns, and potential new therapies. The registry will also track the experience of participants and caregivers in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD Arm | – | –Participants with COPD with frequent exacerbations will be followed from the date of enrollment until death, loss to follow up, withdrawal of consent, or the end of the follow-up period, for up to 3 years. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants at least 40 years of age that have had a COPD diagnosis for at least 12 months, are on stable maintenance therapy, and who have experienced at least two exacerbations in the last 12 months.
Key inclusion criteria (3 listed)
- Diagnosis of COPD for at least 12 months
- On stable, standard of care (SoC) COPD maintenance therapy
- Have experienced at least 2 exacerbations (moderate or severe) in the last 12 months, with one of them occurring while on SoC therapy
Key exclusion criteria (2 listed)
- In palliative treatment
- Participating in any interventional drug trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease course of participants enrolled in COPD registry
Time frame: Up to 3 years
Treatment patterns of participants enrolled in COPD registry
Time frame: Up to 3 years
Treatment patterns of participants enrolled in COPD registry would be monitored through medical records and the changes in the standard of care and potentially moving to other treatments such as biologics.
Number of novel therapies for participants enrolled in COPD registry
Time frame: Up to 3 years
Through medical records, the number and type of novel therapies would be assessed for participants enrolled in COPD registry.
Health care utilization (HCU) by participants enrolled in COPD registry as measured by number of medical visits
Time frame: Up to 3 years
HCU by participants enrolled in COPD registry as measured by types of medical care institutions visited
Time frame: Up to 3 years
Quality of life (QoL) of participants enrolled in COPD registry as measured by the Chronic Airways Assessment Test (CAAT)
Time frame: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the EQ-5D Five Levels plus respiratory dimension (EQ-5D-5L+R) questionnaire
Time frame: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the Work Productivity and Impairment (WPAI)-COPD
Time frame: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the COPD treatment satisfaction questionnaire
Time frame: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the exacerbation experience questionnaire
Time frame: Up to 3 years
Caregiver burden as measured by the Zarit Burden Interview 12-item (ZBI-12)
Time frame: Up to 3 years
Caregiver burden as measured by the Work Productivity and Impairment (WPAI) questionnaire
Time frame: Up to 3 years
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 22 Jun 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- 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.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Hoffmann-La Roche.
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 3 inclusion and 2 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 22 Jun 2026. 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.
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?
Disease course of participants enrolled in COPD registry (time frame: Up to 3 years). The study lists 12 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 22 Jun 2026.