- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01894035
Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation (COMPHI)
Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.
This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the inhalation).
The planned study recruitment time is 18 months. The maximum follow up period in this study will be 12 months.
The data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using I-Neb device) since February 1st, 2013.
Frequency of visits and procedures will be performed under routine conditions. The primary objective of this study is to assess the compliance of patients with WHO/NYHA (World Health Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Multiple Locations, Le Portugal
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Adult patients (age ≥ 18years old), male or female
- Diagnosis of Pulmonary Arterial Hypertension, Group I of the Dana Point Pulmonary Hypertension classification (Diagnosis made at the discretion of the attending investigator, including mPAP ≥ 25 mmHg at rest, as measured by right heart catheterization.)
- The treating physician has chosen to initiate the treatment with inhaled iloprost with I-Neb device for the application, as described in the Summary of Product characteristics (SmPC).
- WHO/NYHA functional class III
- Willing to participate in the study (Informed Consent Sign)
- Patients who received the first inhaled iloprost treatment with I-Neb from February 1st, 2013.
Exclusion Criteria:
- Any contraindication for the treatment with Ventavis as described in the Summary of Product characteristics (SmPC)
- Patients are not to be enrolled if they were treated with inhaled iloprost with I-Neb or any other device for the application in the past, before the start of the observation period (February 1st, 2013)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Groupe 1
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Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of compliant patients
Délai: Up to 12 months
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The compliance will be assessed by the mean daily number of Inhalations and mean daily dose of Ventavis at around months 6 and 12 for each patient (Data will be collected via the I-neb Insight).
For this observational study, a patient is considered compliant if the mean daily number of inhalations and mean daily dose are within 80 to 120% of prescribed.
Otherwise, the patient will be considered as non-compliant.
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Up to 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Observed treatment duration days
Délai: Up to 12 months
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Up to 12 months
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Expected treatment duration days
Délai: Up to 12 months
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Up to 12 months
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Changes in WHO/ NYHA Functional Class
Délai: Up to 12 months
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Up to 12 months
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Change in 6 MWDT (6 minute walking distance test) scale value
Délai: Up to 12 months
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Up to 12 months
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Change in Dyspnea Borg CR (category ratio) 10 scale value
Délai: Up to 12 months
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Up to 12 months
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Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])
Délai: Up to 12 months
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Up to 12 months
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Adjusted percentage treatment duration
Délai: Up to 12 months
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Up to 12 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 16755
- VE1310PT (Autre identifiant: Company internal)
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