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

NCT00995475 | Completed Phase 4 Results

• 1 other identifier: MEN001
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• CRP

  C-reactive protein

  4 weeks

Secondary Outcomes (2)

• Alveolar Nitric Oxide

  4 weeks

• OUCC

  4 weeks

Study Arms (2)

Inhaled corticosteroid, Then placebo

EXPERIMENTAL

FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. After a washout period of 2 weeks, they then received FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks.

Drug: Fluticasone propionate; Drug: Placebo

Placebo control, Then inhaled corticosteroid

PLACEBO COMPARATOR

FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. After a washout period of 2 weeks, they then received FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks.

Drug: Fluticasone propionate; Drug: Placebo

Interventions

Fluticasone propionate DRUG

Inhaled corticosteroid, Then placebo; Placebo control, Then inhaled corticosteroid

Placebo DRUG

Inhaled corticosteroid, Then placebo; Placebo control, Then inhaled corticosteroid

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of asthma, bronchiectasis or ABPA
• Inability to perform study procedures or give informed consent
• Known sensitivity to trial medications

Sponsors & Collaborators

• University of Dundee: lead

Related 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.

  PMID: 21205715 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone

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)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Professor Brian J Lipworth
• Organization: University of Dundee

b.j.lipworth@dundee.ac.uk

+44 1382 383188

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: October 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 19, 2023
• Results First Posted: April 9, 2019

Record last verified: 2019-04