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

University of Dundee

Status and phase: Completed; Phase 4

Conditions: COPD

Treatments: Drug: Placebo; Drug: HFA-BDP

Study type: Interventional

Funder types: Other

Identifiers

NCT00921921

PAW002

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

Extra-fine particle steroid inhaler

Experimental group

Treatment:

Drug: HFA-BDP

Placebo control

Placebo Comparator group

Treatment:

Drug: Placebo