COPD exacerbation MedDRA version: 9.1 Level: SOC Classification code 10038738
Conditions
Interventions
Trade Name: ERDOTIN
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Erdosteine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Sponsors
U.O.PNEUMOLOGIA- AZ. USL1 DI MASSA E CARRARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: hospitalized patiens with COPD exacerbation 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: severe systemic clinic complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of erdosteine activity on systemic inflammation during COPD exacerbation;Secondary Objective: evaluation of erdosteine activity on inflammation biomarkers;Primary end point(s): erdosteine activity on serum biomarkers of inflammation | — |
Countries
Italy
Outcome results
None listed