Evaluation of heparin effects in BPCO patients

Conditions: PATIENTS WITH STABLE CHRONIC OBSTRUCTIVE PULMONARY DISEASE
MedDRA version: 14.1Level: PTClassification code 10061877Term: Obstructive airways disorderSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2010-024168-16-IT

Lead Sponsor: CASA DI CURA PRIVATA S.RAFFAELE - PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients with stable moderate-severe COPD, age 50-75 years, FEV1 (% predicted) 40-70%, and functional residual capacity >120% of predicted normal.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Any hemoptysis of unknown reason Any significant and otherwise unexplainable bleeding with reduction of hemoglobin values by more than 10% in patientâ??s history Preceding surgery within last 6 weeks Diagnosis of gastric or duodenal ulcer or inflammatory bowel disease Diagnosis of oesophageal varicosis of any size Diagnosis colon adenoma with previous gastrointestinal bleeding Current upper/lower respiratory tract infection

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to demonstrate improvement in lung function following inhaled heparin therapy.;Secondary Objective: The secondary objectives are to demonstrate improvements in exercise capacity, dyspnoea, gas trapping and sputum biomarkers of airway inflammation.;Primary end point(s): The main study parameter is forced expiratory volume in one second (FEV1).;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints are a significant improvement in dyspnoea, gas trapping, a decrease in sputum IL-8 levels, C5a, MMP-9, MPO and neutrophil elastase activity, with no significant change in blood coagulation parameters.;Timepoint(s) of evaluation of this end point: 1 year