FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001043-32-GB
Enrollment
20
Registered
2005-04-05
Start date
2005-06-03
Completion date
Unknown
Last updated
2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Product Name: Fluticasone propionate (Neolab Ltd) Pharmaceutical Form: Pressurised inhalation* Pharmaceutical form of the placebo: Pressurised inhalation* Route of administration of the placebo: Inhal

Sponsors

University of Dundee
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with stable moderate COPD (FEV1 > 30% =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 Overnight 10 hour urinary cortisol/creatine ratio—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026