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Clearance in Primary Ciliary Dyskinesia (CLIP)

9 de julho de 2026 atualizado por: University of North Carolina, Chapel Hill

Evaluating Non-ciliary Mechanisms of Airway Clearance in Muco-obstructive Lung Disease

Understanding mechanisms of mucus clearance from the airways may lead to treatments in muco-obstructive lung conditions. Mucociliary clearance (MCC) scans are a way to measure the rate at which a person's lungs can clear inhaled particles. Through a single-arm pilot study in participants with primary ciliary dyskinesia (PCD), the investigators will evaluate the effect of exercise as a way to increase clearance through a mechanism called gas liquid transport (GLT) where the faster flow of air through the lungs during exercise is able to clear more particles. The investigators will repeat MCC measures with exercise after administering hypertonic saline (HS) to evaluate the effects of mucus hydration on both GLT and cough clearance (CC).

Aim 1. To quantify non-ciliary, non-cough mechanisms of mucus clearance (i.e., GLT) in PCD through an MCC protocol that introduces a standardized exercise intervention after isotope delivery.

Aim 2. To evaluate whether exercise-induced GLT and/or CC are responsive to hydrator intervention, using a short acting bronchodilator with 7% HS prior to isotope delivery followed by MCC with exercise intervention.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

The investigators will perform an open label, single-arm interventional pilot study with all participants undergoing the interventions (exercise, and exercise with HS pretreatment) and serving as their own control to evaluate the effects of exercise on non-ciliary mucus clearance mechanisms in PCD to better identify role of GLT and CC. The investigators will also evaluate the effect of pretreatment with HS on GLT (if present) and CC, to determine if these mechanisms of mucus clearance are modifiable by future therapies in PCD and other muco-obstructive lung diseases.

Patients will be asked to attend a total of 3 study visits: screening visit 1 (V1), baseline exercise MCC (visit 2 (V2) or visit 3 (V3)), and HS pretreatment MCC (V2 or V3). Patients will be randomized to perform their baseline exercise MCC scan first or their HS pretreatment MCC scan first to minimize introduction of bias. The time between V1 and V2 will be 3 days to 28 days to allow for flexibility of scheduling, but participants already prescribed HS will be required to undergo a washout period of at least 3 days. V3 will take place at least 3 days after V2 to allow for remaining MCC isotope washout. At V1, tolerability and change in airway caliber in response to HS will be assessed by symptom assessment and spirometry, along with the performance of an exercise assessment to inform the exercise protocol in V2 and V3. From the baseline exercise MCC visit, the primary outcome of Whole Lung Total GLT will be measured. Through comparing the data from the exercise MCC visit and the HS pretreatment MCC visit, change in Whole Lung Total GLT and CC will be determined.

Tipo de estudo

Intervencional

Inscrição (Estimado)

8

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

Estude backup de contato

Locais de estudo

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 18 years old or older
  • Diagnosis of PCD with supporting genetics
  • Lung function with forced expiratory volume in 1 second (FEV1) percent predicted >30%
  • Ability to exercise for 20 minutes (Exercise Assessment performed at screening visit)

Exclusion Criteria:

  • Intolerance to 7% HS
  • Failure of HS tolerance test (HSTT) at visit 1 (V1), defined as a decline of 10% in FEV1 from baseline pre-bronchodilator (BD) FEV1 after 7% HS
  • Intolerance to levalbuterol
  • Exercise-induced asthma
  • Complex congenital heart disease or other exercise limitation
  • Lung transplantation or listed for lung transplantation
  • History of lung resection of the lung analyzed by MCC (depending on situs status)
  • Pregnancy or unwillingness to use approved birth control during study period
  • Recent hemoptysis (>60 ml in the last 3 months)
  • Pulmonary exacerbation in preceding 4 weeks
  • Change in pulmonary therapies within preceding 4 weeks
  • Resting or exertional O2 requirement (nocturnal acceptable)
  • Tobacco / smoking history (any within last year, and >10 pack year history in past)
  • More than 2 chest computed tomography (CT) scans in the past year or a combination of procedures believed to have exposed the lungs to >150 millisieverts (mSv), including from other research studies
  • Participation in another interventional trial within 30 days

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Exercise with and without HS pretreatment
All participants will undergo interventions of exercise alone, and exercise with HS pretreatment, in two separate study visits according to randomization to intervention sequence.
Comportamental: Exercise
At either V2 or V3, after 16 minutes of baseline MCC data collection, participants will perform 20 minutes of moderate-intensity exercise based on the Borg Rating of Perceived Exertion (RPE) scale, on a cycle ergometer. The goal through this moderate intensity exercise is to increase respiratory rate and airflow velocity, thereby potentially inducing GLT. Participants will then resume MCC scan data collection post-exercise to continue to measure the effects induced by exercise on clearance from the lungs.
Outro: HS pretreatment with Exercise
At either V2 or V3, prior to the start of baseline MCC scanning, participants will undergo pretreatment with 4 puffs of inhaled levalbuterol (90 mcg per actuation, via spacer) followed by 4 ml of 7% HS via nebulizer. Participants will then start MCC scan data collection, and after 16 minutes of baseline MCC collection they will then complete 20 minutes of moderate intensity exercise according to the Borg RPE on a cycle ergometer. After 20 minutes, MCC scan will resume to continue to measure rates of clearance following HS pretreatment and exercise.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Whole Lung Total GLT
Prazo: Either Day 1 (Visit 2) or up to Day 28 (Visit 3) depending on randomization to sequence intervention
Through MCC scan with built in exercise protocol, the investigators will measure the effects of exercise on rates of clearance of radiolabeled isotopes from the lungs, thought to represent GLT. The investigators will measure the difference between retained particles from immediately before (after collection of 16 minutes of baseline MCC data through eight 2-minute images) and immediately after 20 minutes of moderate intensity exercise on a cycle ergometer (40 minutes after start of MCC data collection). This will represent Active GLT. The investigators will then resume measurement of MCC clearance rate by serial 2-minute image collection of the whole lung from 40 minutes to 70 minutes. This will represent Sustained GLT. The sum of Active and Sustained GLT will represent Whole Lung GLT. This measurement will occur at either Visit 2 or Visit 3, depending on visit sequence randomization.
Either Day 1 (Visit 2) or up to Day 28 (Visit 3) depending on randomization to sequence intervention
Change in Whole Lung Total GLT after HS pretreatment
Prazo: Day 3 to 28, depending on timing of Visit 3
After pretreatment with levalbuterol and 7% HS, participants will undergo an MCC scan with built in exercise protocol. The investigators will measure the effects of exercise on rates of clearance of radiolabeled isotopes from the lungs, thought to represent GLT. The investigators will measure Active GLT and Sustained GLT after HS pretreatment, which taken together will represent Whole Lung GLT after HS pretreatment. This measurement will occur at either Visit 2 or Visit 3 depending on visit sequence randomization. The difference between Whole Lung GLT from exercise alone will be compared with the HS pretreatment Whole Lung GLT.
Day 3 to 28, depending on timing of Visit 3
Change in Cough Clearance (CC) after HS Pretreatment
Prazo: Day 3 to 28, depending on timing of Visit 3
The investigators will measure the effects of exercise and HS pretreatment on rates of clearance of radiolabeled isotopes from the lungs during a period of controlled coughs at regular intervals. During Visit 2 and Visit 3 MCC scans, from minutes 70 through 100 of MCC data collection, participants will be instructed to perform 30 voluntary huff-cough maneuvers while serial 2-minute images are obtained. The change in clearance during this time will represent CC. At one of these visits (either Visit 2 or Visit 3 depending on randomization to intervention sequence), participants will undergo pretreatment with levalbuterol and 7% HS prior to the MCC scan with exercise protocol. The difference between CC after exercise alone and CC after exercise with HS pretreatment will be measured.
Day 3 to 28, depending on timing of Visit 3

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of North Carolina, Chapel Hill

Colaboradores

Cystic Fibrosis Foundation

Investigadores

  • Investigador principal: Katherine A Despotes, MD, University of North Carolina, Chapel Hill

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 (Estimado)

30 de julho de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

29 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de julho de 2026

Primeira postagem (Real)

13 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 25-1650

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

The investigators will not share individual participant data (IPD) with other researchers to protect patient confidentiality.

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

produto fabricado e exportado 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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