Skip to main content
OpenTrials
Completed

NCT Number: NCT00921921

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma and Allergy Research Group, University of Dundee

Dundee, Tayside, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HFA-BDP

Drug

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

Other names: Qvar

Placebo

Drug

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

Primary outcomes

  1. Alveolar Nitric Oxide

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2009
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.