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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    50
  • sponsor
    AstraZeneca
Updated on 16 April 2021

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.

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.

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease)
Clinical Study IdentifierNCT04168216
SponsorAstraZeneca
Last Modified on16 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 40 yrs?
Gender: Male or Female
Do you have any of these conditions: COPD (Chronic Obstructive Pulmonary Disease) or Chronic Obstructive Lung Disease?
Do you have any of these conditions: Chronic Obstructive Lung Disease or COPD (Chronic Obstructive Pulmonary Disease)?
Do you have any of these conditions: COPD (Chronic Obstructive Pulmonary Disease) or Chronic Obstructive Lung Disease?
Do you have any of these conditions: Chronic Obstructive Lung Disease or COPD (Chronic Obstructive Pulmonary Disease)?
Do you have any of these conditions: COPD (Chronic Obstructive Pulmonary Disease) or Chronic Obstructive Lung Disease?
Do you have any of these conditions: Chronic Obstructive Lung Disease or COPD (Chronic Obstructive Pulmonary Disease)?
Do you have any of these conditions: COPD (Chronic Obstructive Pulmonary Disease) or Chronic Obstructive Lung Disease?
Do you have any of these conditions: Chronic Obstructive Lung Disease or COPD (Chronic Obstructive Pulmonary Disease)?
Do you have any of these conditions: Chronic Obstructive Lung Disease or COPD (Chronic Obstructive Pulmonary Disease)?
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 (2 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 >0.1109 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 g 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-RS, and BCSS during the last 3 weeks prior to Visit 2
Blood eosinophils >0.1109 cells/L at Visit 2
Negative pregnancy test (urine) for female subjects of childbearing potential at Visit 2

Exclusion Criteria

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