Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease enrolled in the study SPHERIC-1 MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SILDENAFIL CITRATE
CAS Number: 171599-83-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Sponsors
ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients enrolled in the study SPHERIC-1 who completed the study with stable COPD in optimal pharmacological treatment (Eur Respir J 2004; 23: 932-946), chronic oxygen therapy in patients with hypoxia, with PaO2 at rest = 60 mmHg and PaCO2 = 55 mmHg, aged between 18 and 80 years old 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exlusion criteria as previous study SPHERIC-1: • Different types of pulmonary hypertension (chronic, thromboembolic pulmonary hypertension, pulmonary arterial hypertension etc.) • Significant left cardiac disease (LVEF <45%, cardiomyopathy, valvulopathy, unstable coronaropathy) • Treatment with nitrates in the last 10 days, or in need of other nitrate therapy for different diseases • Treatment with other specific drugs for arterial pulmonary hypertension (less than 4 weeks) • Significant systemic disease other than COPD • Recent reacutization of chronic bronchitis (< 4 weeks) • Pregnancy or breastfeeding, or women without an adequate contraceptive method for the whole study duration • History of anaphylaxys or allergic reactions to 5-phosphodiesterase inhibitors • Cancers within the last 5 years with the exception of localized cancers of the skin or of the cervix • Hepatic insufficiency or chronic renal failure or hemoglobinemia < 10 g/dL during the screening phase • Contraindications to subministration as per SPC • Mental disorder, alcohol abuse, chronic alcoholism, drug abuse • Subjects unable to sign the informed consent form • Subjects unable to walk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Observation of the use of sildenafil for pulmonary hypertension associated with COPD in patients enrolled in the previous clinical trial titled SPHERIC-1;Secondary Objective: Not applicable;Primary end point(s): Registration of any adverse events during administration of sildenafil citrate 20 mg every 8 hours for 12 months;Timepoint(s) of evaluation of this end point: 12 months (visits at 3 and 6 month or according to clinical practice) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Italy
Contacts
Public ContactCENTRO STUDI AIPO
ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI
Outcome results
None listed