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 - SYSTEMIC AND LOCAL EFFECTS OF INHALED FLUTICASONE
Phase 1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- EUCTR2005-001043-32-GB
- Lead Sponsor
- niversity of Dundee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Patients with stable moderate COPD (FEV1 > 30% <50%) age50 years and over will be included
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Those with known or suspected hypersensitivity to any of the Investigational Medicinal Products and those with a recent (within the last 2 months) respiratory tract infection will be excluded.
Cor pulmonalae
Domicillary oxygen therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect of inhaled corticosteroid on levels of surrogate inflammatory markers, specifically CRP, in relation to markers of systemic absorbtion;Secondary Objective: ;Primary end point(s): Serum CRP and hs CRP levels<br>Overnight 10 hour urinary cortisol/creatine ratio
- Secondary Outcome Measures
Name Time Method