Status:
UNKNOWN
SPHERIC-1. Sildenafil and Pulmonary HypERtension In COPD
Lead Sponsor:
Italian Association of Hospital Pneumologists
Conditions:
Pulmonary Hypertension
COPD
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Although pulmonary hypertension (PH) is a quite frequent complication of advanced pulmonary diseases, and it is an independent prognostic factor, until now no evidence-based treatment approach exists ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 exacerbations of chronic bronchitis (\< 4 weeks)
- Pregnancy or breastfeeding, or women without an adequate contraceptive method for the whole study duration
- History of anaphylaxis 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01441934
Start Date
October 1 2010
End Date
February 1 2013
Last Update
February 4 2013
Active Locations (10)
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1
Pulmonary Unit - Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, Milano, Italy, 20162
2
Pulmonary Diseases Clinic - Azienda Ospedaliera Universitaria - Policlinico di Modena
Modena, Modena, Italy, 41100
3
Pulmonary Clinic - Federico II University - Azienda Ospedaliera V. Monaldi
Napoli, Napoli, Italy, 80131
4
Thoracic Surgery Clinic - Azienda Ospedaliera di Padova
Padua, Padova, Italy, 35128