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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

This study has been completed.
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00995475
First received: October 14, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 Intervention Phase
COPD
 Drug: Fluticasone propionate
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • CRP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alveolar nitric oxide [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • OUCC [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: October 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled corticosteroid Drug: Fluticasone propionate
Placebo Comparator: Placebo control Drug: Placebo

  Eligibility

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Peter Alan Williamson, University of Dundee
ClinicalTrials.gov Identifier: NCT00995475     History of Changes
Other Study ID Numbers: MEN001
Study First Received: October 14, 2009
Last Updated: October 14, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013