Moderate to severe pulmonary hypertension associated to moderate to mild COPD. MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sildenafil
Concentration unit: mg milligram(s)
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of ad
Sponsors
ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the superiority of sildenafil (20 mg tid) compared to placebo in the reduction of the pulmonary vascular resistance after 16 weeks of treatment.;Secondary Objective: Evaluation of sildenafil safety profile in comparison to placebo. Evaluation of sildenafil effect on the exercise capacity, symptoms and quality of life in comparison to placebo.;Primary end point(s): Significant reduction of basal pulmonary vascular resistance at rest, after 16 weeks of treatment with sildenafil compared with placebo. | — |
Countries
Italy
Outcome results
None listed