SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1

• Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Moderate to severe pulmonary hypertension associated to moderate to mild COPD.

• Registration Number: EUCTR2010-020917-97-IT
• Lead Sponsor: ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patient affected by stable COPD under optimal treatment, chronic oxygen therapy in patients with hypoxia, with PaO2 at rest = 60 mmHg and PaCO2= 55 mmHg, aged between 18 and 80 years old: • Group 1: BPCO GOLD I-III (post bronchodilator FEV1 = 30%, FEV1/FVC = 0,7 , TLC = 70%) + PAPm = 30 mmHg and PCP <15 mmHg • Group 2: BPCO GOLD IV (post bronchodilator FEV1 <30%, FEV1/FVC = 0,7 , TLC = 70%) + PAPm = 35 mmHg and PCP <15 mmHg.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified