A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995475
• Other study ID #: MEN001
• Status: Completed
• Phase: Phase 4
• Start date: October 2006
• Est. completion date: November 2008

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 (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.

C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.

It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Current or ex-smokers

• Aged over 50years

• FEV1/FVC ratio <0.7

• FEV1<80% predicted

• Improvement in FEV1 following short acting beta-agonist not greater than 15% and 200ml.

Exclusion Criteria:

• Diagnosis of asthma, bronchiectasis or ABPA

• Inability to perform study procedures or give informed consent

• Known sensitivity to trial medications

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Fluticasone propionate

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

References & Publications (1)

Williamson PA, Menzies D, Clearie KL, Vaidyanathan S, Lipworth BJ. Dose-response for inhaled fluticasone on airway and systemic inflammation in COPD. Eur Respir J. 2011 Jan;37(1):206-9. doi: 10.1183/09031936.00062210. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRP	C-reactive protein	4 weeks
Secondary	Alveolar Nitric Oxide		4 weeks
Secondary	OUCC	Overnight urinary cortisol creatinine ratio	4 weeks