An investigation into how adding an inhaled steroid to COPD treatment may potentially protect against heart disease.

Phase 2

• Conditions: Chronic Obstructive Airways Disease [COPD]; Respiratory

• Registration Number: ISRCTN29148209
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-18
• Last Update Posted: 9 September 2024
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Males and females aged =40 years old
2. Primary respiratory diagnosis of COPD
3. FEV-1 <80% predicted and FEV-1/FVC <0.7 at screening
4. Current or former smoker with at least 10 pack year smoking history
5. Able to demonstrate adequate inhaler technique with a pMDI inhaler and willing to take study medications as instructed
6. =2 moderate and/or =1 severe exacerbation of COPD (AECOPD) within the 12 months prior to recruitment*
7. Willing to undertake study procedures and assessments
8. Provided written informed consent
* A moderate exacerbation is classified as an AECOPD treated with oral antibiotics and/or corticosteroids without ED attendance and/or hospitalisation. A severe AECOPD is one that requires ED attendance and/or hospitalisation

Exclusion Criteria

1. Other significant respiratory condition felt to be the primary cause for the patients symptoms and/or exacerbations (e.g. predominant asthma, bronchiectasis or interstitial lung disease)
2. Exacerbation of COPD requiring oral steroids and/or antibiotics within the 4 weeks prior to recruitment
3. Unstable vascular disease (e.g. unstable angina, acute myocardial infarction), cerebrovascular event (transient ischaemic attack or stroke), peripheral vascular disease (symptomatic intermittent claudication, critical limb ischaemia) within 3 months of screening.
4. Venous thromboembolic event (e.g. deep vein thrombosis or pulmonary embolism) within 3 months of screening
5. Treatment with 1 or more medication that will impact outcome measure assessment (e.g. clopidogrel, ticagrelor etc). *low dose Aspirin therapy will be permissible if taken at a stable dose throughout the study
6. Taking an inhaled corticosteroid (ICS) prior to study entry with a blood eosinophil count =0.3 x 10^9 per litre during the screening visit
7. (This criterium has been included to avoid risk to patients from ICS withdrawal during run-in and wash-out periods for patients considered to have required ICS by a clinician prior to study entry and with evidence of steroid responsive disease [Eos =0.3 x 10^9/L])
8. Known allergy/sensitivity to study medications
9. Current participation in another interventional clinical study within 30-days or, if involving an Investigational Product, 5-half-lives, whichever is longer
10. For women of child bearing potential only - currently pregnant, breast feeding, or planned pregnancy during the study or not using acceptable contraception, as judged by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in platelet activation measured by P-selectin expression (unstimulated and following stimulation with escalating concentrations of ADP and collagen) using FACs analysis following treatment with inhaled BUD/GLY/FORM compared with inhaled GLY/FORM measured at 16 weeks.