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Evaluation of heparin effects in BPCO patients

A TRIAL OF INHALED NEBULISED UNFRACTIONATED HEPARIN SODIUM IN PATIENTS WITH STABLE CHRONIC OBSTRUCTIVE PULMONARY DISEASE - Heparin and COPD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-024168-16-IT
Enrollment
Unknown
Registered
2012-03-01
Start date
2011-09-02
Completion date
Unknown
Last updated
2016-04-11

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

Conditions

PATIENTS WITH STABLE CHRONIC OBSTRUCTIVE PULMONARY DISEASE MedDRA version: 14.1 Level: PT Classification code 10061877 Term: Obstructive airways disorder System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: CLARISCO*EV SC 10F 12500UI/0,5 Pharmaceutical Form: Solution for injection INN or Proposed INN: Heparin Concentration unit: U/ml unit(s)/millilitre Concentration number: 25000- Pharmaceuti

Sponsors

CASA DI CURA PRIVATA S.RAFFAELE - PISANA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Italy

Contacts

Public ContactSEGRETERIA SCIENTIFICA

IRCCS SAN RAFFAELE PISANA

astrid.vanrijn@sanraffaele.it06/52253405

Outcome results

None listed

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