Does Extra-fine Hydrofluoroalkane-beclomethasone Dipropionate (HFA-BDP) Suppress Small Airways Inflammation in Chronic Obstructive Pulmonary Disease (COPD)?

Does Extra-fine HFA-BDP Suppress Small Airways Inflammation in COPD?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00921921

Enrollment

Registered

2009-06-17

Start date

2009-06-30

Completion date

2011-10-31

Last updated

2019-04-12

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

Conditions

COPD

Brief summary

Chronic obstructive pulmonary disease or 'COPD' is a chronic disease, which means that it cannot be cured, but that inhalers and tablets can be used to control the symptoms. In COPD, the airways become inflamed which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in COPD. The airways of the lung start in the windpipe and branch like the branches of a tree, getting smaller and smaller. In COPD the inflammation is deep in the lungs, out to the very small airways. Different inhalers make the medicines into different sized particles. Most steroid inhalers used for COPD make the medicine into particles which are too big to get into the very small airways ('coarse particles'). Other inhalers make a mist, with much smaller particles ('fine particles'). These are as small as the smallest airways in the lungs. Doctors have recently found a way to measure the inflammation in the small airways that are affected in COPD. The investigators want to find out if taking one of these 'fine-particle' steroid inhalers can treat that inflammation.

Interventions

DRUGHFA-BDP

HFA-BDP 100 mcg bid for 3 weeks, then 400 mcg bid for 3 weeks

DRUGPlacebo

1 puff bid for 3 weeks, then 1 puff bid for 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Current or ex-smokers * \> 40 years of age with a greater than 15 pack year history of smoking * post-bronchodilator FEV1/FVC ratio \< 0.7 * FEV1 \< 80% predicted * CANO \> 3 ppb at screening * Informed consent and ability to perform exhaled nitric oxide assessment

Exclusion criteria

* Oral steroid use or exacerbation within 6 weeks * Greater than 2 exacerbations requiring treatment in the previous 6 months * Requirement for domiciliary oxygen * Pregnancy or lactation * Known or suspected contra-indication to any of the IMP's * Diagnosis of asthma

Design outcomes

Primary

Measure	Time frame
Alveolar Nitric Oxide	6 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026