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Inhaled corticosteroids in Chronic Obstructive Pulmonary Disease (COPD)

Inhaled corticosteroids (ICS) in subjects with mild to moderate Chronic Obstructive Pulmonary Disease (COPD). Does Bronchodilator reversibility and an asthmatic airway phenotype predict for ICS response?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000249459
Enrollment
35
Registered
2007-05-08
Start date
2004-01-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The use of inhaled corticosteroids is well established in asthma, but whether they exert a beneficial effect in smoking related chronic obstructive pulmonary disease (COPD) is less clear. There are suggestions that patients with COPD who have a disease with similarities to asthma, i.e. a good spirometric response to salbutamol and a pattern of airway inflammation with predominant eosinophils (a characteristic cell in asthma), will respond more favourably to ICS. In this study, we tested our hypothesis that COPD patients with features similar to asthma, i.e. bronchodilator reversibility and an airway eosinophilia would exhibit a better response to ICS. We assessed this using airway biopsies at the beginning and end of a six month ICS study.

Interventions

A randomised, placebo-controlled trial of inhaled fluticasone propionate (500 Mmicrograms twice daily) over six months on airway inflammation in mild to moderate COPD.

Sponsors

GlaxoSmithKline
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

A physician diagnosis of COPD and evidence of airflow limitation on spirometry.

Exclusion criteria

Potential participants were interviewed and examined by a respiratory physician and any history suggestive of asthma, i.e. symptoms present in childhood, related atopic disorders, eczema or hay fever, significant day-to-day variability or prominent nocturnal symptoms, or a history of wheeze rather than progressive breathlessness and any previous use of ICS excluded that subject from further participation. Other exclusion criteria included significant uncontrolled co-morbidities such as diabetes, angina or cardiac failure, and other co-existing respiratory disorders, i.e. pulmonary fibrosis, lung cancer and bronchiectasis.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026