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

University of Dundee

Status and phase: Completed; Phase 4

Conditions: COPD

Treatments: Drug: Fluticasone propionate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00995475

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Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Inhaled corticosteroid, Then placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Fluticasone propionate

Placebo control, Then inhaled corticosteroid

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Fluticasone propionate