- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00708227
Pharmacogenetics of b2-Agonists in Asthma.
Visão geral do estudo
Status
Condições
Descrição detalhada
Patients are being asked to take part in this research study because they have asthma. This clinical research study is being done to see if an asthmatic's gene make-up (DNA is made up of genes) affects the way they respond to a particular asthma medication called salmeterol. Certain genes make people tall or short. Certain genes give people brown or black hair. Similarly, certain genes may be associated with the way patients respond to asthma medications.
Salmeterol xinafoate (a long acting bronchodilator) and fluticasone propionate (an inhaled corticosteroid) are the medicines contained in Advair Diskus. During this study, patients with asthma will receive fluticasone inhaler (called Flovent) and Advair Diskus. The investigators want to find out if patients with asthma with certain genes respond in different ways to the salmeterol in Advair Diskus. The investigators also want to find out if patients with asthma with certain genes who are treated with salmeterol for two weeks have their airways open up less than usual when they use albuterol.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Florida
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Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Diplotype: Whites with specific diplotype and African Americans with specific diplotypes.
- Gender: Male or female. Women are eligible if they are not pregnant or lactating. Females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test.
- Age: 10 years and older.
- Asthma Diagnosis: Physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months.
- Asthma Therapy: There is no requirement for previous asthma therapy to be included in this study.
- Asthma Severity: forced expiratory volume in the first second (FEV1) must be >= 60% of predicted normal values for age, height, and gender.
- methacholine challenge test provocative concentration (20% fall in FEV1) of <=12]mg/ml.
Exclusion Criteria:
- History of life-threatening asthma: Any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
- Asthma instability: Hospitalization for asthma within 3 months of Visit 1.
- Concurrent respiratory disease: Any respiratory disease other than asthma.
- Sensitivities: Sensitivities to methacholine, Flovent® MDI, ipratropium bromide, albuterol, or Advair Diskus® that would put the safety of the subject at risk.
- Respiratory Tract Infection: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to Visit 1.
- Expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. These patients can be studied when pollen exposure to which they are sensitive will not occur.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Case-Crossover
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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Whites ADRB2:ARG16ARG
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
Whites ADRB2:GLY16GLY
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
African American ADRB2:ARG16ARG
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
African American ADRB2:GLY16GLY
All participants receive fluticasone for 2-weeks followed by fluticasone / salmeterol for 2-weeks at a dose commensurate with baseline inhaled corticosteroid dose.
All participants receive ipratropium bromide for symptom rescue therapy.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Log10 PC20 to Methacholine After Visit 2
Prazo: Visit 2:12 hours after last dose of Flovent
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Visit 2 log10 PC20 after receiving 2 weeks of Flovent
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Visit 2:12 hours after last dose of Flovent
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Log10 PC20 to Methacholine After Visit 3
Prazo: Visit 3:12 hours after the last dose of Advair
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Visit 3 Log10 PC20 after receiving 2 weeks of Advair
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Visit 3:12 hours after the last dose of Advair
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Log10 PC20 to Methacholine After Visit 4
Prazo: 36 hours after the last dose of Advair
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Visit 4 log10 PC20 to Methacholine after stopping Advair
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36 hours after the last dose of Advair
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Bronchodilator Response to Methacholine (PC20) After Visit 2
Prazo: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent.
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The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge.
2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response).
FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes.
Participants had received Flovent for 2 weeks at Visit 2.
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0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent.
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Bronchodilator Response Following Methacholine Challenge at Visit 3
Prazo: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair
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The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge.
2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response).
FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes.
Participants had received Advair for 2 weeks at Visit 3.
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0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair
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Bronchodilator Response Following Methacholine Challenge at Visit 4
Prazo: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair
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The area under the curve (AUC) bronchodilator response after Visit 4 methacholine challenge.
2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response).
FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes.
Participants had discontinued Advair for 36 hours.
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0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kathryn Blake, Pharm.D., Nemours Children's Clinic
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 82211
- K23HL081245 (Concessão/Contrato do NIH dos EUA)
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