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

Phase 4

Completed

• Conditions: COPD
• Interventions: Drug: HFA-BDP; Drug: Placebo

• Registration Number: NCT00921921
• Lead Sponsor: University of Dundee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Extra-fine particle steroid inhaler	HFA-BDP	-
Placebo control	Placebo	-

Primary Outcome Measures

Name	Time	Method
Alveolar Nitric Oxide	6 weeks

Trial Locations

Locations (1)

Asthma and Allergy Research Group, University of Dundee; 🇬🇧 Dundee, Tayside, United Kingdom