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OpenTrials
Completed

NCT Number: NCT00995475

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

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.

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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

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Fluticasone propionate

Drug

Placebo

Drug

Primary outcomes

  1. CRP

    Time frame: 4 weeks

    C-reactive protein

Secondary outcomes

  1. Alveolar Nitric Oxide

    Time frame: 4 weeks

  2. OUCC

    Time frame: 4 weeks

    Overnight urinary cortisol creatinine ratio

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2009
Registry last updated
May 19, 2023

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.

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