Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01441934
Eligibility 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 \<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 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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01441934
Study Brief:
Protocol Section:
NCT01441934