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

NCT04168216 | Completed

• 1 other identifier: D6930R00002
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease, COPD

Outcome Measures

Primary Outcomes (8)

• 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.

  Inflammation: FeNO (daily) Blood eosinophils, CRP, and EDN (fortnightly) Sputum eosinophils and neutrophils (weekly)

  12 weeks

• 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.

  Lung function: FEV1, PEF, Oscillometry (daily)

  12 weeks

• 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.

  Symptoms: BCSS (daily)

  12 weeks

• 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.

  Symptoms: E-RS (daily)

  12 weeks

• 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.

  Symptoms: VAS-COPD (daily)

  12 weeks

• 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.

  Symptoms: SGRQ (fortnightly)

  12 weeks

• 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.

  Symptoms: CAT (fortnightly)

  12 weeks

• 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.

  Reliever use: Ventolin® use (daily)

  12 weeks

Secondary Outcomes (8)

• 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

• 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

• 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 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 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

Other Outcomes (2)

• Exploratory Biomarker data will be plotted for each subject over the 12 weeks of the study / around a COPD worsening event to provide an understanding of the temporal dynamics of the data.

  12 weeks

• Exploratory Night time symptoms data will be plotted for each subject over the 12 weeks of the study / around a COPD worsening event to provide an understanding of the temporal dynamics of the data.

  12 weeks

Eligibility Criteria

• Age: 40 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include patients diagnosed with symptomatic COPD and blood eosinophil count \>0.1×109 cells/L, who are receiving maintenance treatment with a long-acting β2 agonist (LABA) in combination with ICS and/or a long-acting muscarinic antagonist (LAMA) and require use of an inhaled short-acting bronchodilator (β2 agonists or anticholinergics) as rescue medication. The study will include both current and former smokers (with at least 10 pack-year history) and intends to recruit a maximum of 30% current smokers.

You may qualify if:

• Provision of signed and dated, written ICF prior to any study specific procedures, sampling, and analyses (at Visit 1).
• Male or female subjects ≥40 years of age at the time of signing the ICF.
• A physician diagnosis of COPD and receiving maintenance treatment with a LABA in combination with an ICS, a LAMA, or both (ie, LABA+ICS, LABA+LAMA, or LABA+ICS+LAMA), for at least 3 months prior to Visit 1.
• Physician-documented prescription and subject-confirmed use of an inhaled short-acting bronchodilator (β2 agonists or anticholinergics) as rescue medication prior to study.
• Current or ex-smoker with ≥10 pack-year history.
• Post-bronchodilator FEV1/FVC \<0.7 recorded in medical history.
• Blood eosinophils \>0.1×109 cells/L.
• The subject must be able to read, speak, and understand English; and be able to, in the Investigator's judgment, comply with the Study Protocol.
• Negative pregnancy test (urine) for female subjects of childbearing potential at Visit 1
• Incusion Criteria for Entry in the Observational Period:
• Frequent use of SABA (≥200 µg of Ventolin per day, for at least 75% of days in the 3 weeks prior to Visit 2).
• At least 70% compliance with daily FeNO, spirometry, EXACT, and BCSS during the last 3 weeks prior to Visit 2.
• Blood eosinophils \>0.1×109 cells/L at Visit 2.
• Negative pregnancy test (urine) for female subjects of childbearing potential at Visit 2.

You may not qualify if:

• 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.
• Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than COPD.
• Concurrent diagnosis of asthma (subjects with a history of asthma may be included).
• Any disease currently treated with chronic oral/systemic corticosteroids.
• Subjects with a history/treatment of malignancy, and which in the Investigator's opinion could compromise the safety of the subject.
• 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.
• Subjects currently treated with eosinophil-depleting medications (ie, mepolizumab, benralizumab), or who have been treated within 5.5 half-lives of eosinophil-depleting medications.
• 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.
• 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.
• 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.
• Subjects with a known hypersensitivity to the treatment or any of the excipients of Duaklir and Ventolin.
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• 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).
• Previous entry into the observation period in the present study.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• University of Oxford: collaborator

Study Sites (1)

Research Site

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Links

• CSR Synopsis

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, sputum, nasal and urine samples will be collected for exploratory research. Blood samples will be collected for future genetic/DNA research.

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

• Mona Bafadhel, Professor

  Respiratory Department Churchill Hospital Old Road OX3 7LE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: November 19, 2019
• Study Start: November 30, 2020
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

GB (1)