Study of Relationship Between Changes in Inflammation, Lung Function, Symptoms and Medication Use in COPD Patients

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT04168216
• Lead Sponsor: AstraZeneca

Brief Summary

The intention with the study is to have a better understanding of what happens to COPD patients' symptoms, lung function and markers of inflammation over 12 weeks. This information will increase the understanding of COPD and how to design new treatments for COPD in the future.

Detailed Description

This is a Phase IV, open-label, single-arm, single-site study. The purpose of this exploratory study is to gain longitudinal insights into the relationships between the inflammatory profile, symptoms, lung function, and reliever use in subjects with chronic obstructive pulmonary disease (COPD).

The study will include a minimum of 8 clinic visits and consist of a Screening Visit (Visit 1), a 4-week run-in period, a Baseline Visit (Visit 2) and a 12-week observational period, including 6 visits scheduled every 2 weeks. To standardise the use of COPD medications all subjects will receive maintenance Duaklir and reliever Ventolin for the duration of the study. During the observational period, additional visits may occur if subjects experience a worsening of their COPD symptoms. For each individual subject, the duration of participation in the study will be 16 weeks.

Estimated study duration is approximately 20 months including approximately 50 patients.

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Study Start: 2020-11-30
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

1. As judged by the Investigator, any evidence of drug/substance abuse which would pose a risk to subject safety, interfere with the conduct of study, have an impact on the study results, or affect the subject's ability to participate in the study.

2. Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than COPD.

3. Concurrent diagnosis of asthma (subjects with a history of asthma may be included).

4. Any disease currently treated with chronic oral/systemic corticosteroids.

5. Subjects with a history/treatment of malignancy, and which in the Investigator's opinion could compromise the safety of the subject.

6. Other Concurrent Medical Conditions: Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.

7. Subjects currently treated with eosinophil-depleting medications (ie, mepolizumab, benralizumab), or who have been treated within 5.5 half-lives of eosinophil-depleting medications.

8. Subjects who have had a COPD exacerbation requiring oral corticosteroids and/or antibiotics in the last 30 days before the run-in period. Subjects will be able to be re-screened 30 days following an exacerbation.

9. Participation in another clinical study with any marketed or investigational biologic drug within 4 months or 5 half-lives (whichever is longer) prior to Visit 1.

10. Participation in another clinical study with a non-biologic investigational product or new formulation of a marketed non-biologic drug during the last 30 days prior to Visit 1 that, in the opinion of the Investigator, could impact the results of the current study.

11. Subjects with a known hypersensitivity to the treatment or any of the excipients of Duaklir and Ventolin.

12. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

13. Judgment by the Investigator that the subject should not participate in the study if the subject is unlikely to complete the observational period (eg, literacy, substance abuse, life-threatening comorbidity).

14. Previous entry into the observation period in the present study.

15. For women only - currently pregnant (confirmed with positive pregnancy test), breast-feeding or planned pregnancy during the study. Women of childbearing potential not using acceptable contraceptive measures, as judged by the Investigator.

16. As judged by the Investigator, planned hospitalisation/vacation during the study that interferes with study assessments.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammation data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.	12 weeks	Inflammation: FeNO (daily) Blood eosinophils, CRP, and EDN (fortnightly) Sputum eosinophils and neutrophils (weekly)
Lung function data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.	12 weeks	Lung function: FEV1, PEF, Oscillometry (daily)
Symptoms data (SGRQ) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: SGRQ (fortnightly)
Symptoms data (CAT) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: CAT (fortnightly)
Symptoms data (VAS-COPD) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: VAS-COPD (daily)
Symptoms data (BCSS) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: BCSS (daily)
Reliever use data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.	12 weeks	Reliever use: Ventolin® use (daily)
Symptoms data (E-RS) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: E-RS (daily)

Secondary Outcome Measures

Name	Time	Method
Symptoms data (CAT) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: CAT (fortnightly)
Lung function data will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.	12 weeks	Lung function: FEV1, PEF, Oscillometry (daily)
Reliever use data will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.	12 weeks	Reliever use: Ventolin® use (daily)
Symptoms data (VAS-COPD) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: VAS-COPD (daily)
Symptoms data (SGRQ) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: SGRQ (fortnightly)
Inflammation data will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.	12 weeks	Inflammation: FeNO (daily) Blood eosinophils, CRP, and EDN (fortnightly) Sputum eosinophils and neutrophils (weekly)
Symptoms data (BCSS) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: BCSS (daily)
Symptoms data (E-RS) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.	12 weeks	Symptoms: E-RS (daily)

Trial Locations

Locations (1)

Research Site; 🇬🇧 Oxford, Oxfordshire, United Kingdom