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- Ensaio Clínico NCT05218564
Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement
30 de janeiro de 2022 atualizado por: Paolo Banfi, Fondazione Don Carlo Gnocchi Onlus
Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement. An Experimental, Randomised, Two-arm, Counterbalanced Study With Three Data Collection Sessions.
COPD (Chronic Obstructive Pulmonary Disease) is a disease of the respiratory system characterised by irreversible airway obstruction of varying severity.
The disease (known as COPD, Chronic Obstructive Pulmonary Disease) is progressive and is associated with a state of chronic inflammation of the lung tissue, which leads to a real remodelling of the bronchi causing a significant reduction in airway flow.
Among the possible treatments, while the placebo is considered as an inert treatment, lacking any intrinsic therapeutic properties, there is evidence in the literature that not all placebos are equivalent and some are more effective than others, as for example in the case of migraine or osteoarthritis.
The differences found between different types of placebos (e.g.
oral, subcutaneous, intra-articular...) indicate that placebos are not inert but rather consist of multiple psychosocial elements that are part of the ritual of the therapeutic act.
This is also the context for the studies by Lacasse et al. (for the International Nocturnal Oxygen (INOX) Research Group et al., 2017) and Jarosh et al., who investigated the effects of oxygen therapy both during sleep and during the course of daily life, studying its influences through the use of placebo in patients suffering from hypoxemia.
However, in the literature, there are no studies investigating the role of oxygen (O2) during the performance of a test such as the Walking Test, otherwise known as the 6 Minute Walking Test (6MWT) compared with a placebo in patients with Chronic Obstructive Pulmonary Disease (COPD), nor whether the use of the latter would lead to comparable results.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
102
Estágio
- Não aplicável
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.
Contato de estudo
- Nome: Paolo Banfi, MD
- Número de telefone: 00390239703341
- E-mail: pabanfi@dongnocchi.it
Estude backup de contato
- Nome: Eleonora Volpato, PhD
- E-mail: evolpato@dongnocchi.it
Locais de estudo
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Milan, Itália, 20148
- Recrutamento
- IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
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Contato:
- Paolo Banfi, MD
- Número de telefone: 0039 0240308812
- E-mail: pabanfi@dongnocchi.it
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Contato:
- Eleonora Volpato, PhD
- Número de telefone: 0039 0240308812
- E-mail: evolpato@dongnocchi.it
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Subjects who voluntarily agree to participate in the study;
- Subjects with moderate-grade Chronic Obstructive Pulmonary Disease (COPD) (GOLD 2-50% ≤ FEV1 <80% of predicted) according to GOLD criteria;
- Subjects undergoing treatment with oxygen therapy and non-smokers;
- Ex-smokers
- Outpatients and inpatients
Exclusion Criteria:
- Refusal of Informed Consent
- Severe cognitive impairment, detected by administration of the Mini Mental Status Examination Test (MMSE)
- Pregnancy
- Patients with oncological or psychiatric pathologies
- Main immunodepression
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 cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Group 1, consisting of participants with COPD and usually using O2
In this group, in addition to the standard care, the participant undergoes the 6 Minute Walking Test (6MWT) using compressed medical air (RA) cylinders, believing that there is oxygen (O2) inside the cylinder.
The same, then, in addition to the standard care, is subjected to the execution of the 6 Minute Walking Test (6MWT), thanks to the use of cylinders of Oxygen (O2), believing that inside the cylinder there is Oxygen (O2).
The sequence of this group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen).
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During the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g.
corridor) in six minutes, including as many breaks as he/she deems necessary.
The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed.
The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen).
The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
Outros nomes:
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Comparador de Placebo: Group 2, consisting of participants with COPD and usually not using O2
In this group, in addition to standard care, the participant is given the 6 Minute Walking Test (6MWT) using oxygen (O2) cylinders, believing that there is oxygen (O2) inside the cylinder.
Next, the participant undergoes the 6 Minute Walking Test (6MWT), using compressed medical air (RA) cylinders, believing that there is oxygen (O2) inside the cylinder.
The sequence of this group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
|
During the 6 Minute Walking Test (6MWT), the participant will be required to walk as fast as possible on a flat, straight surface on the ward (e.g.
corridor) in six minutes, including as many breaks as he/she deems necessary.
The performance of this test will be monitored continuously by a Respiratory Physiotherapist and will include the presence of a Physician, who will be ready to assist as needed.
The sequence of use of compressed medical air and oxygen used during the 6MWT in the first group will then be characterised as follows: ABC (A=Baseline, B=Air, C=Oxygen).
The sequence of the second group will be characterised as follows: ACB (A=Baseline, B=Air, C=Oxygen).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Metres covered during 6 Minute Walking Test (6MWT)
Prazo: Changes from baseline at the metres covered after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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Distance in metres during the 6 Minute Walking Test (6MWT)
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Changes from baseline at the metres covered after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS)
Prazo: Changes from baseline at the FSS after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS).
The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree.
The minimum score=9 and maximum score possible=63.
Higher the score=greater fatigue severity.
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Changes from baseline at the FSS after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC)
Prazo: Change from baseline at the dyspnoea after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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VAS Dyspnoea, measured by the British Medical Research Council's Modified Questionnaire (mMRC).
The mMRC breathlessness scale ranges from grade 0 to 4.
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Change from baseline at the dyspnoea after the completion of the 6MWT performed using oxygen or compressed medical air. Up to 1 hour and half
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Saturation (SpO2)
Prazo: Change from baseline at 3':30'' and at 6':00'' of the 6 Minute Walking Test (6MWT)
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Saturation (SpO2)
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Change from baseline at 3':30'' and at 6':00'' of the 6 Minute Walking Test (6MWT)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
- Bannuru RR, McAlindon TE, Sullivan MC, Wong JB, Kent DM, Schmid CH. Effectiveness and Implications of Alternative Placebo Treatments: A Systematic Review and Network Meta-analysis of Osteoarthritis Trials. Ann Intern Med. 2015 Sep 1;163(5):365-72. doi: 10.7326/M15-0623.
- Barnes PJ. Chronic obstructive pulmonary disease: a growing but neglected global epidemic. PLoS Med. 2007 May;4(5):e112. doi: 10.1371/journal.pmed.0040112.
- Benedetti F. Placebo and the new physiology of the doctor-patient relationship. Physiol Rev. 2013 Jul;93(3):1207-46. doi: 10.1152/physrev.00043.2012.
- Benedetti F. Placebo effects: from the neurobiological paradigm to translational implications. Neuron. 2014 Nov 5;84(3):623-37. doi: 10.1016/j.neuron.2014.10.023. Epub 2014 Nov 5.
- Benedetti F, Dogue S. Different Placebos, Different Mechanisms, Different Outcomes: Lessons for Clinical Trials. PLoS One. 2015 Nov 4;10(11):e0140967. doi: 10.1371/journal.pone.0140967. eCollection 2015.
- Benedetti F, Durando J, Giudetti L, Pampallona A, Vighetti S. High-altitude headache: the effects of real vs sham oxygen administration. Pain. 2015 Nov;156(11):2326-2336. doi: 10.1097/j.pain.0000000000000288.
- Benedetti F, Durando J, Vighetti S. Nocebo and placebo modulation of hypobaric hypoxia headache involves the cyclooxygenase-prostaglandins pathway. Pain. 2014 May;155(5):921-928. doi: 10.1016/j.pain.2014.01.016. Epub 2014 Jan 21.
- Berry MJ, Rejeski WJ, Adair NE, Zaccaro D. Exercise rehabilitation and chronic obstructive pulmonary disease stage. Am J Respir Crit Care Med. 1999 Oct;160(4):1248-53. doi: 10.1164/ajrccm.160.4.9901014.
- Blinderman CD, Homel P, Billings JA, Tennstedt S, Portenoy RK. Symptom distress and quality of life in patients with advanced chronic obstructive pulmonary disease. J Pain Symptom Manage. 2009 Jul;38(1):115-23. doi: 10.1016/j.jpainsymman.2008.07.006. Epub 2009 Feb 20.
- de Craen AJ, Tijssen JG, de Gans J, Kleijnen J. Placebo effect in the acute treatment of migraine: subcutaneous placebos are better than oral placebos. J Neurol. 2000 Mar;247(3):183-8. doi: 10.1007/s004150050560.
- Dowson CA, Kuijer RG, Mulder RT. Anxiety and self-management behaviour in chronic obstructive pulmonary disease: what has been learned? Chron Respir Dis. 2004;1(4):213-20. doi: 10.1191/1479972304cd032rs.
- Lacasse Y, Bernard S, Series F, Nguyen VH, Bourbeau J, Aaron S, Maltais F; International Nocturnal Oxygen (INOX) Research Group. Multi-center, randomized, placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease: a study protocol for the INOX trial. BMC Pulm Med. 2017 Jan 9;17(1):8. doi: 10.1186/s12890-016-0343-9.
- Jarosch I, Gloeckl R, Damm E, Schwedhelm AL, Buhrow D, Jerrentrup A, Spruit MA, Kenn K. Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients With COPD: A Randomized, Placebo-Controlled, Single-blind, Crossover Trial. Chest. 2017 Apr;151(4):795-803. doi: 10.1016/j.chest.2016.11.044. Epub 2016 Dec 8.
- Kong J, Spaeth R, Cook A, Kirsch I, Claggett B, Vangel M, Gollub RL, Smoller JW, Kaptchuk TJ. Are all placebo effects equal? Placebo pills, sham acupuncture, cue conditioning and their association. PLoS One. 2013 Jul 31;8(7):e67485. doi: 10.1371/journal.pone.0067485. Print 2013.
- Wong CJ, Goodridge D, Marciniuk DD, Rennie D. Fatigue in patients with COPD participating in a pulmonary rehabilitation program. Int J Chron Obstruct Pulmon Dis. 2010 Oct 5;5:319-26. doi: 10.2147/COPD.S12321.
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 (Real)
19 de fevereiro de 2020
Conclusão Primária (Antecipado)
30 de março de 2022
Conclusão do estudo (Antecipado)
31 de dezembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
28 de dezembro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de janeiro de 2022
Primeira postagem (Real)
1 de fevereiro de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de fevereiro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de janeiro de 2022
Última verificação
1 de janeiro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FDG_Placebo_COPD
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .
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