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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921921
• Other study ID #: PAW002
• Status: Completed
• Phase: Phase 4
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Inflammation
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• HFA-BDP
HFA-BDP 100 mcg bid for 3 weeks, then 400 mcg bid for 3 weeks
• Placebo
1 puff bid for 3 weeks, then 1 puff bid for 3 weeks

Locations

Country	Name	City	State
United Kingdom	Asthma and Allergy Research Group, University of Dundee	Dundee	Tayside

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Short PM, Williamson PA, Lipworth BJ. Effects of extra-fine inhaled and oral corticosteroids on alveolar nitric oxide in COPD. Lung. 2012 Aug;190(4):395-401. doi: 10.1007/s00408-012-9378-8. Epub 2012 Feb 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar Nitric Oxide		6 weeks