A COPD Data Registry for Participants With Frequent Exacerbations

NCT07059273 | Not Yet Recruiting

• 1 other identifier: BA45495
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (12)

• Disease course of participants enrolled in COPD registry

  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.

  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.

  Up to 3 years

• Health care utilization (HCU) by participants enrolled in COPD registry as measured by number of medical visits

  Up to 3 years

• HCU by participants enrolled in COPD registry as measured by types of medical care institutions visited

  Up to 3 years

• Quality of life (QoL) of participants enrolled in COPD registry as measured by the Chronic Airways Assessment Test (CAAT)

  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

  Up to 3 years

• QoL of participants enrolled in COPD registry as measured by the Work Productivity and Impairment (WPAI)-COPD

  Up to 3 years

• QoL of participants enrolled in COPD registry as measured by the COPD treatment satisfaction questionnaire

  Up to 3 years

• QoL of participants enrolled in COPD registry as measured by the exacerbation experience questionnaire

  Up to 3 years

• Caregiver burden as measured by the Zarit Burden Interview 12-item (ZBI-12)

  Up to 3 years

• Caregiver burden as measured by the Work Productivity and Impairment (WPAI) questionnaire

  Up to 3 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• In palliative treatment
• Participating in any interventional drug trials

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BA45495 https://forpatients.roche.com/

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 10, 2025
• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share