A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial (SAPS)
2 de janeiro de 2019 atualizado por: Joe Ramsdell, University of California, San Diego
SAPS:Smoking Asthmatics Pilot Study:
The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of implementing the provisional design of the full scale TOM trial (e.g., the six month treatment period, the impact of the smoking cessation intervention).
There is no active hypothesis for the Vanguard Protocol.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The protocol is a small scale pilot of the full-scale TOM trial, and it will utilize a placebo design and incorporates 4 treatment arms. In the Vanguard Protocol all participants are to complete a 4 week run-in with Advair 100/50, followed by randomization to 1 of 4 arms of study treatment. The 4 drug treatment combinations are (2 inhalers, 2 pills):
- Advair 250/50, Placebo, Placebo, Placebo
- Advair 100/50 and montelukast, Placebo, Placebo
- Advair 100/50 and theophylline, Placebo, Placebo
- Advair 100/50 and ipratropium, Placebo, Placebo The 24 week treatment phase will be followed by a 4 week washout period on Advair 100/50. There is no crossover.
Tipo de estudo
Intervencional
Inscrição (Real)
20
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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San Diego, California, Estados Unidos, 92103
- Airway Research & Clinical Trials Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Gender and Age:
- Males and females, ages 18- 50
Current Smoker:
- Smoke at least 5 cigarettes per day for at least 5 years
- Positive urine cotinine test
Asthma:
- Physician diagnosed asthma
Symptomatic, as evidenced by
- Use of SABA two or more times per week for relief of asthma symptoms, or
- One or more nocturnal awakenings per week for asthma symptoms ACRC - SC MEETING - 19 MAY 2012 SAPS │ 25 Confidential, not for attribution or citation.
- Pre-BD FEV1 greater than or equal to 40% predicted
Asthma diagnosis confirmed by either
- albuterol reversibility of FEV1 by 12% or more, or
- 20% fall in FEV1 at 8mg or less of methacholine
- If over age 45, a DLco greater than 80% predicted
- Females of childbearing potential: not pregnant, not lactating and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
Exclusion Criteria:
- Diagnosis of COPD or emphysema
Other major chronic illnesses in the opinion of the investigator that might interfere with the study:
- e.g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, renal failure, liver disease, non-skin cancer, unstable psychiatric illness.
- Recent active substance abuse (in past 6 months)
- Lung disease other than asthma including COPD, bronchiectasis, sarcoidosis, or other significant lung disease
- Unstable cardiac disease (decompensated CHF, unstable angina, recent MI, atrial fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension).
High risk of near fatal or fatal asthma as defined by the following 1-3
- ICU admission of asthma in the past year
- more than 2 hospitalizations for asthma in the previous year
- more than 3 ED visits for asthma in the previous year
- intubation or ICU admission for asthma in the past 2 years
- use of more than 2 canisters of inhaled short-acting beta2-agonist in past month
- Acute asthma exacerbation in the past 4 weeks (treatment with systemic corticosteroids)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de Placebo: Ipratropium
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and placebo montelukast.
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Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.
Outros nomes:
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Comparador de Placebo: Theophylline
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.
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Participants will be assigned to theophylline once a day for 24 weeks
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Comparador de Placebo: Montelukast
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.
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Participants will be assigned to montelukast once a day for 24 weeks.
Outros nomes:
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Comparador de Placebo: fluticasone 250 mg/salmeterol 50mg
Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.
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Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Asthma Control Test
Prazo: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.
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The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults.
The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control.
It consists of five questions with five possible answers each.
A maximum score of 25 points indicates complete asthma control.
A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score <16 indicates uncontrolled asthma.
The minimally important clinical difference has been determined to be 3.
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Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Asthma Symptom Utility Index (ASUI)
Prazo: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were compared
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The Asthma Symptom Utility Index (ASUI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics.
ASUI is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects.
11 items are reviewed, with 2-week recall to assess four symptoms (cough, wheeze, shortness of breath, and awakening at night) and medication side-effects each on two dimensions (frequency and severity).
4-point Likert scale is used to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe).
Scores range from 0 (worst possible symptoms) to 1 (no symptoms).
The change between two time points, initial visit and after 24 weeks of treatment, is reported.
The median value is reported with the standard deviation.
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Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were compared
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Percent (%) Perdicted FEV1 Changes
Prazo: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were compared
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Physiologic measures of % predicted FEV1
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Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were compared
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Joe Ramsdell, MD, UCSD
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de outubro de 2012
Conclusão Primária (Real)
1 de maio de 2015
Conclusão do estudo (Real)
1 de novembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
25 de junho de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de setembro de 2012
Primeira postagem (Estimativa)
28 de setembro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de janeiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de janeiro de 2019
Última verificação
1 de janeiro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Doenças do sistema imunológico
- Doenças pulmonares
- Hipersensibilidade, Imediata
- Doenças brônquicas
- Doenças Pulmonares Obstrutivas
- Hipersensibilidade Respiratória
- Hipersensibilidade
- Asma
- Efeitos Fisiológicos das Drogas
- Agentes Adrenérgicos
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Vasodilatadores
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Antagonistas colinérgicos
- Agentes colinérgicos
- Inibidores Enzimáticos
- Antiinflamatórios
- Antagonistas purinérgicos
- Agentes Purinérgicos
- Glicocorticóides
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agonistas Adrenérgicos
- Agentes dermatológicos
- Agentes broncodilatadores
- Agentes Antiasmáticos
- Agentes do Sistema Respiratório
- Antagonistas de Leucotrieno
- Antagonistas Hormonais
- Indutores do citocromo P-450 CYP1A2
- Indutores Enzimáticos do Citocromo P-450
- Agentes Antialérgicos
- Inibidores da fosfodiesterase
- Antagonistas dos Receptores P1 Purinérgicos
- Agonistas de Receptores Beta-2 Adrenérgicos
- Beta-Agonistas Adrenérgicos
- Simpaticomiméticos
- Montelucaste
- Teofilina
- Fluticasona
- Xhance
- Salmeterol Xinafoato
- Combinação de Medicamentos Fluticasona-Salmeterol
- Ipratrópio
Outros números de identificação do estudo
- ARCTC-09
- IR34HL109482-01A1 (Número de outro subsídio/financiamento: National Heart, Lung, and Blood Institute (NHLBI))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
results will be presented been publication four-minute meetings
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .