COPD
Conditions
Interventions
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Fluticasone
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical Form: Inhalation powder
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: COPD outpatients in stage II and III of GOLD classification. Patients will be smokers or ex-smokers since at least 6-months, with a similar degree of severity, while on their usual drug therapy. 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
Exclusion criteria: No actual use of steroids or antioxidants (i.e. N-acetilcysteine), no evidence of exacerbation in the preceeding 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the study are: 1) assess exhaled NO (eNO) in stable, smoke-free and steroid-naive COPD patients, 2) measure the effects of 14-day therapy with inhaled fluticasene diproprionate bid (added to standard tiotropium)on exhaled eNO production;Secondary Objective: eNO level will be then compared with those from other proinflammatory biomarkers obtained from exhaled condensate and induced sputum.;Primary end point(s): eNO level | — |
Countries
Italy
Outcome results
None listed