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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Extra-fine particle steroid inhaler

Group Type EXPERIMENTAL

HFA-BDP

Intervention Type DRUG

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

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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HFA-BDP

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Qvar

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No