- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00861211
Safety and Efficacy Study of Oral Senicapoc on Allergen Challenge in Atopic Asthmatic Subjects
8 de julio de 2011 actualizado por: Icagen
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess The Safety and Efficacy of Two Weeks of Oral Senicapoc Administration on Allergen Challenge in Atopic Asthmatic Subjects
The purpose of the study is to determine whether senicapoc can decrease changes in FEV1 following allergen challenge in atopic allergic subjects.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Based on the unmet medical need for new agents in the treatment of asthma and the role of KCa3.1 in the function of several different cell types involved in the inflammatory response, and the effects seen in an animal model of allergic asthma, it is reasonable to explore the utility of senicapoc, a KCa3.1 blocker, as a novel treatment of asthma.
This study will test the ability of senicapoc to alleviate bronchospasm induced by an allergen challenge in patients with allergic asthma.
It is analogous to the study performed in animals in which senicapoc demonstrated the ability to reduce airway resistance and hyper-responsiveness induced by airway challenge with antigen and carbachol, respectively.
This study is also the first to test the ability of senicapoc to reduce airway inflammation, which is the key pathophysiologic process in asthma.
In summary, with a demonstrated safety profile across a wide range of doses in humans and efficacy in an animal model of allergic bronchospasm and hyper-responsiveness, the initiation of exploratory studies of senicapoc for treatment of asthma is justified.
Tipo de estudio
Intervencionista
Inscripción (Actual)
34
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
UK
-
London, UK, Reino Unido, SE1 1YR
- Guy's Drug Research Unit
-
Manchester, UK, Reino Unido, M23 9QZ
- Medicines Evaluation Unit
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- History of asthma (as defined by the Global Initiative in Asthma definition or having been previously treated for asthma);
- Baseline (pre-bronchodilator) forced expiratory volume at one second (FEV1) ≥70% of predicted;
- Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests );
- Positive response on screening to skin prick test to either house dust mite, cat hair, or grass pollen;
- A positive inhaled methacholine challenge with a PC20 ≤ 8 mg/mL (within 6 months prior to Screening Visit 1);
- Screening allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of equal to or more than 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of equal to or more than 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen;
- Non-smoker (refrained from any tobacco usage or any products containing nicotine for 6 months prior to Screening Visit 1);
- Able and willing to give written informed consent to participate in the study.
Exclusion Criteria:
- Any subject who has experienced any allergic reaction to a drug that suggests an increased potential for a hypersensitivity to senicapoc (e.g. clotrimazole);
- Previous ingestion of senicapoc (ICA-17043) prior to Screening Visit 1;
- Any condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs;
- Respiratory tract infection or asthma exacerbation within 4 weeks of the first Screening Visit or within the period between Screening Visit 1 and Day 1 unless study physician believes lung function was unaffected (no greater than 10% decrease in baseline FEV1) by such event;
- Considering or scheduled to undergo any surgical procedure during the duration of the study;
- History of alcohol and/or drug abuse within 2 years prior to Screening Visit 1;
- Donation of blood (>450 mL) or significant loss of blood within 56 days prior to Screening Visit 1;
- Received any commercially licensed investigational product within 30 days prior to Screening Visit 1 or received any unlicensed investigational product within 90 days prior to Screening Visit 1;
- History of chronic hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infection, or demonstration of HIV antibodies;
- A positive qualitative urine drug test, a positive urine or breath alcohol test, or a positive urine cotinine or CO breath test at the first Screening visit or on Day 1;
- Use of oral or inhaled or intranasal corticosteroid, long acting beta agonists (e.g., salmeterol or formoterol), leukotriene receptor antagonists (e.g., zafirlukast or montelukast), theophylline, nedocromil sodium, cromolyn sodium, zileuton , or anti-cholinergic agents within the 28 days prior to the first Screening visit;
- Use of oral antihistamines within 1 week prior to the first Screening visit;
- Symptomatic with hay fever during any of the Screening Visits or Day 1;
- A >10 pack year cigarette history.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo
|
Comparador de placebos
|
Experimental: Active treatment arm
|
Loading Dose: 80 mg twice daily x 3 days followed by Maintenance Dose: 40 mg daily x 11 days
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Decrease in FEV1 between 4-10 hours (Late Asthmatic Response) after allergen challenge and will compare the active (40 mg QD) vs. placebo treatment groups with respect to change in response to allergen challenge.
Periodo de tiempo: after 2 weeks of treatment with study medication
|
after 2 weeks of treatment with study medication
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Early allergen response to allergen challenge, measure of airway hyperreactivity to methacholine challenge, pulmonary function tests (FEV1 and FVC), fraction of exhaled NO, cell differentials and cytokine measurements from induced sputum samples.
Periodo de tiempo: after 2 weeks of study medication
|
after 2 weeks of study medication
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Tak H Lee, FRCP, Guy's Drug Research Unit, Quintiles Limited
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2008
Finalización primaria (Actual)
1 de marzo de 2009
Finalización del estudio (Actual)
1 de mayo de 2009
Fechas de registro del estudio
Enviado por primera vez
12 de marzo de 2009
Primero enviado que cumplió con los criterios de control de calidad
12 de marzo de 2009
Publicado por primera vez (Estimar)
13 de marzo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de julio de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
8 de julio de 2011
Última verificación
1 de julio de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ICA-17043-17
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .