SPHERIC-1OE: study of the duration of 12 months for the observation of the use of sildenafil for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease in patients enrolled in the previous study titled SPHERIC-1

• Conditions: Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease enrolled in the study SPHERIC-1; MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-002018-35-IT
• Lead Sponsor: ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-30
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

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

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

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

Study & Design

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