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- Registre américain des essais cliniques
- Essai clinique NCT01001364
A Comparative Study Between Foraseq And Formoterol/Budesonide Inhalation Capsules in Patients With Asthma (CAINAS)
A Phase III, Randomized, Open-Label, Non-Inferiority Comparative Study Between Foraseq Inhalation Capsules 12/200 µg And Formoterol/ Budesonide Inhalation Capsules 12/200 µg Eurofarma In Patients With Asthma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma. This is a non-inferiority study, which hypothesis is that there is no difference on the pulmonary function measure between the groups studied at its end. Therefore, the study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.
This study secondary objective is to compare the impact on the clinical control of two products containing budesonide and formoterol as individual capsules with inhalation powder in subjects with persistent asthma.
The secondary endpoints considered for this study are:
- Score of asthma control questionnaire (ACQ-7) 34 at the end of the study ;
- Peak of expiratory flow (PEF) throughout the study;
- Symptoms score at the end of the study;
- FEV1 throughout the study;
- Treatment safety, including serum cortisol dosage;
- Frequency of observed adverse events.
Some eligibility criteria:
- Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
- Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) < 3.0;
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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SP
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São Paulo, SP, Brésil, 05437 010
- Centro de Pesquisa Clínica Stelmach
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Sign ICF (see Attachment A);
- Age ≥12 years old
- Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) < 3.0;
- Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
- Initial FEV1 of at least 50% of the normal value estimated.
- Serum cortisol evaluation within the normal values
Exclusion Criteria:
- Use of oral or parenteral corticosteroids within the last 3 months;
- Need of hospitalization due to asthma within the last 3 months;
- Active tabagism, defined as the use of cigarettes, pipe, cigar or any other type in any amount within the last 3 months;
- Severe co-morbidity, such as cardiovascular, renal, liver, neurologic, neoplastic, blood, infectious, dermatologic, neurologic, psychiatric or chronic respiratory diseases, other than asthma;
- Recent participation (<6 months) or planned participation, during this study, on other clinical trials involving drugs of any nature or under studies of any type of intervention for the asthma treatment;
- Intolerance or allergy to any of the compounds of the drugs evaluated on the study;
- Pregnancy or lactation;
- Chronic use of routine oral or intravenous β-blocker drugs, even ophthalmic solutions.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Formoterol/Budesonide
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formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.
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Comparateur actif: Foraseq
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formoterol will be administered at the 12 µg dosage, twice a day, and budesonide will be administered at the 200 µg dose, also twice a day for 12 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.
Délai: 4 months
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4 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study.
Délai: 4 months
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4 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- Maladies des voies respiratoires
- Maladies du système immunitaire
- Maladies pulmonaires
- Hypersensibilité immédiate
- Maladies bronchiques
- Maladies pulmonaires obstructives
- Hypersensibilité respiratoire
- Hypersensibilité
- Asthme
- Effets physiologiques des médicaments
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Agents anti-inflammatoires
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agonistes adrénergiques
- Agents bronchodilatateurs
- Agents anti-asthmatiques
- Agents du système respiratoire
- Agonistes des récepteurs bêta-2 adrénergiques
- Bêta-agonistes adrénergiques
- Budésonide
- Fumarate de formotérol
Autres numéros d'identification d'étude
- EF-091
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Essais cliniques sur Formoterol/Budesonide
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Chiesi Farmaceutici S.p.A.Complété