- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05218564
Air as a Placebo: Increasing the Respiratory Performance of People With COPD Through Simple Expectations of Improvement
30 de enero de 2022 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
102
Fase
- No aplica
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.
Estudio Contacto
- Nombre: Paolo Banfi, MD
- Número de teléfono: 00390239703341
- Correo electrónico: pabanfi@dongnocchi.it
Copia de seguridad de contactos de estudio
- Nombre: Eleonora Volpato, PhD
- Correo electrónico: evolpato@dongnocchi.it
Ubicaciones de estudio
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Milan, Italia, 20148
- Reclutamiento
- IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
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Contacto:
- Paolo Banfi, MD
- Número de teléfono: 0039 0240308812
- Correo electrónico: pabanfi@dongnocchi.it
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Contacto:
- Eleonora Volpato, PhD
- Número de teléfono: 0039 0240308812
- Correo electrónico: evolpato@dongnocchi.it
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
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 cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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).
Otros nombres:
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Metres covered during 6 Minute Walking Test (6MWT)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Feeling of fatigue, as measured by the Fatigue Severity Scale (FSS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
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 (Actual)
19 de febrero de 2020
Finalización primaria (Anticipado)
30 de marzo de 2022
Finalización del estudio (Anticipado)
31 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
28 de diciembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
30 de enero de 2022
Publicado por primera vez (Actual)
1 de febrero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
30 de enero de 2022
Última verificación
1 de enero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FDG_Placebo_COPD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
Ensayos clínicos sobre Compressed Medical Air
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Ann & Robert H Lurie Children's Hospital of ChicagoTerminado
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University of Wisconsin, MadisonTerminadoVía aérea difícil | Anestesia; FuncionalEstados Unidos
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Massachusetts General HospitalTerminadoAsfixia Perinatal | Asfixia neonatal | Asfixia de nacimiento
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CIBA VISIONTerminadoPresbicia | Astigmatismo | Miopía
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air up GmbHCitruslabsReclutamiento
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ResMedTerminadoRespiración trastornada del sueñoEstados Unidos
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Chang Gung Memorial HospitalReclutamiento
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ResMedTerminadoApnea del Sueño ObstructivaEstados Unidos
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AlyatecTerminado