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ReclutandoNCT07924462Registro de ClinicalTrials.gov

Chronic Respiratory Disease Participant Engagement Study

Interstitial Lung Disease (ILD) · Chronic Respiratory Diseases · Alpha-1 Antitrypsin Deficiency (AATD) · Chronic Obstructive Pulmonary Disease (COPD) · Asthma · Bronchiectasis

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
500 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This study is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as Alpha-1 Antitrypsin Deficiency (AATD), chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, or interstitial lung disease (ILD).

The aim of the study is to help participants become familiar with the clinical trials unit environment and research team before deciding whether they would like to take part in future clinical trials.

Participants will attend a study visit at the clinical trials unit, where they will receive a guided tour of the facilities and undergo a range of routine health assessments. These may include a review of their medical history, measurements of height, weight, blood pressure and oxygen levels, breathing tests, blood tests, heart tracing (ECG), liver assessment, and questionnaires about their symptoms and quality of life. Some participants may also undergo genetic testing if it is clinically appropriate and previous results are not available.

The information collected will help establish a clinical baseline and improve understanding of how respiratory diseases affect people in everyday life. The study will also explore how symptoms and quality of life relate to clinical measurements and other health information.

Participants will be contacted after their visit to discuss any clinically relevant findings and to answer any questions they may have. If a previously unrecognised condition is identified, participants will be advised appropriately and, with their consent, their GP may be informed to support any further care that may be needed.

The findings from this study may help improve the design of future clinical trials and support the development of more patient-centred research.

Leer la descripción completa

This study is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as AATD, COPD, asthma, bronchiectasis, or ILD.

This study will help participants become familiar with the clinical trials unit environment and research team. The findings from this study may help improve the design of future clinical trials and support the development of more patient-centred research.

This is a participant engagement study and will take about 5 weeks to complete. There is no overnight stay, and no investigational drug will be given.

The study involves two visits; Visit 1: An in-person engagement visit (Day 1) and Visit 2: A follow-up about 3 weeks (±14 days) after Day 1.

During the Day 1 visit, participants will be asked to provide written informed consent. After providing consent, participants will be given a tour of the clinical study unit to get familiar with the environment and facilities. Following informed consent on Day 1, participants will undergo a unit tour and undergo a range of routine health assessments. These may include a review of their medical history, measurements of height, weight, blood pressure and oxygen levels, breathing tests, blood tests, heart tracing (ECG), liver assessment, and questionnaires about their symptoms and quality of life. Some participants may also undergo genetic testing if it is clinically appropriate and previous results are not available.

A Follow-Up with the Study Doctor will be conducted within 3 weeks (±14 days) after Day 1 to discuss the results of the clinical assessments. The participants will have the opportunity to ask any further questions. If a participant has a confirmed new genetic or respiratory diagnosis and they are not already receiving appropriate care from a specialist, they will be provided with appropriate counselling regarding the finding and, where clinically indicated, their General Practitioner (GP) will be informed to support ongoing clinical management and will be referred to an appropriate specialist.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

1. Male or female participants aged ≥ 18 years at the date of signing the PIS/ICF.
2. Ability to provide written, personally signed, and dated informed consent in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines E6 (R3) (2025) and applicable regulations, before any study-specific procedures are performed.
3. Diagnosis with or suspicion of chronic respiratory disease including but not limited to: AATD, COPD, Asthma, Bronchiectasis, ILD and any other chronic respiratory diseases considered appropriate by the Investigator and Sponsor

Exclusion Criteria:

1. Unwilling or unable to comply with the protocol-defined study assessments.
2. Any other significant disease or disorder that, in the opinion of the Principal Investigator (PI) or Sponsor, may either place the participant at risk from participation, or influence the clinical baseline

Población del estudio

Adult participants aged 18 years or older with a confirmed or suspected chronic respiratory disease, including alpha-1 antitrypsin deficiency, chronic obstructive pulmonary disease, asthma, bronchiectasis, interstitial lung disease or other chronic respiratory conditions considered appropriate by the Investigator and Sponsor, who are considering participation in future relevant clinical trials.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
Group 1

No informado en este registro.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Number of patients indicating willingness to be re-contacted for future clinical trials

Plazo: Until the end of the study (up to 5 weeks)]

No informado en este registro.

Participation feedback questionnaire results using Participant Feedback and Clinical Research Experience Questionnaire

Plazo: Until the end of the study (up to 5 weeks)]

No informado en este registro.

Medidas secundarias

Clinical baseline characterisation of medical history

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of exacerbation history

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of smoking status

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of concomitant medications (con-meds)

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of respiratory rate

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of body temperature

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of pulse rate

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of oxygen saturation

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of blood pressure

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of Lung function for FEV1 parameter

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of Lung function for FVC parameter

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of Lung function for FEV1/FVC ratio

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of oxygen use

Plazo: Day 1

No informado en este registro.

Clinical baseline characterisation of bloods including genetic testing where clinically indicated and imaging data where available.

Plazo: Day 1

No informado en este registro.

Number and proportion of new diagnoses following assessment

Plazo: Until the end of the study (up to 5 weeks)]

No informado en este registro.

Factors associated with underdiagnosis by exploring differences between patient-reported outcomes and clinical data, including potential variations by age, sex and ethnicity

Plazo: Until the end of the study (up to 5 weeks)]

No informado en este registro.

Differences in patient-reported outcome scores between chronic respiratory disease subgroups using EQ-5D-5L together with the EQ Visual Analogue Scale (EQ VAS)

Plazo: Until the end of the study (up to 5 weeks)]

No informado en este registro.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Richmond Pharmacology LimitedLondon, United KingdomReclutando
Edward Jackson, MBChB PhDPRINCIPAL_INVESTIGATOR
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Equipo y fechas

Patrocinador principal
Richmond Research Institute
Inicio del estudio
2026-11 Estimado
Finalización primaria
1 ago 2027 Estimado
Finalización del estudio
1 ago 2027 Estimado
Primera publicación
9 nov 2026 Real
Última actualización
9 nov 2026 Real

Contactos oficiales del estudio

Título oficial del estudio

Engagement Study to Establish a Clinical Baseline for Adult Participants With Chronic Respiratory Diseases and Familiarise Them With the Clinical Trials Unit Environment for Future Clinical Trial Participation

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.

No incluyas expedientes médicos, diagnósticos, medicamentos, números de seguro ni otros datos sensibles. Este formulario es para preguntas generales, no para atención urgente.

Enviar una pregunta no te inscribe en un estudio.

Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026