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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

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ClinicalTrials.gov Identifier: NCT00995475
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:
University of Dundee

Brief 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.


Condition or disease Intervention/treatment Phase
COPD Drug: Fluticasone propionate Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Inhaled corticosteroid Drug: Fluticasone propionate
Placebo Comparator: Placebo control Drug: Placebo



Primary Outcome Measures :
  1. CRP [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Alveolar nitric oxide [ Time Frame: 4 weeks ]
  2. OUCC [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Alan Williamson, University of Dundee
ClinicalTrials.gov Identifier: NCT00995475     History of Changes
Other Study ID Numbers: MEN001
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents