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

NCT00921921 | Completed Phase 4

• 1 other identifier: PAW002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Alveolar Nitric Oxide

  6 weeks

Study Arms (2)

Extra-fine particle steroid inhaler

EXPERIMENTAL

Drug: HFA-BDP

Placebo control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HFA-BDP DRUG

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

Also known as: Qvar

Extra-fine particle steroid inhaler

Placebo DRUG

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

Placebo control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Asthma and Allergy Research Group, University of Dundee

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related 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.

  PMID: 22350679 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

GB (1)