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Bronchial Hyperresponsiveness in Sarcoidosis

2026年10月30日 更新者:Agata Lewandowska、Bydgoszcz University of Science and Technology

The Impact of Bronchial Hyperresponsiveness and Asthma on Quality of Life in Patients With Sarcoidosis, Taking Into Account Radiological Phenotypes and Stages of Sarcoidosis

Pulmonary sarcoidosis may be accompanied by obstructive ventilatory defects and bronchial hyperresponsiveness (BHR), which can mimic the clinical presentation of asthma. In clinical practice, bronchial challenge tests are used as an adjunctive tool in the diagnosis of asthma in patients with suggestive symptoms but normal spirometry results. However, BHR is not specific to asthma and is also observed in patients with sarcoidosis. Further research is warranted by reports suggesting an association between BHR and the severity of respiratory symptoms in patients with pulmonary sarcoidosis. To assess the prevalence of BHR in the course of sarcoidosis and identify factors associated with its occurrence, methacholine bronchial challenge tests were performed in patients with sarcoidosis.

Despite the existing hypotheses explaining the presence of bronchial hyperresponsiveness in sarcoidosis, its pathogenesis remains largely unknown. The use of a methacholine bronchial challenge test and the assessment of its association with pulmonary radiological findings may help identify patients with sarcoidosis who are at increased risk of bronchial hyperresponsiveness, as well as improve our understanding of the mechanisms underlying its development.

研究概览

详细说明

This was an observational, analytical, cross-sectional study with a retrospective component. The prospective component of the study assessed BHR using methacholine bronchial challenge testing in patients with established sarcoidosis.

Of the 81 patients with sarcoidosis assessed for eligibility, 70 were ultimately included in the study, having met all inclusion criteria and none of the exclusion criteria. The study protocol was developed in accordance with ATS/ERS recommendations. A 2-minute tidal breathing method with continuous inhalation of progressively increasing methacholine concentrations was used. Patients who exhibited less than a 20% decline in FEV1 at concentrations above 16 mg/ml were classified as having normal bronchial responsiveness. Based on the methacholine bronchial challenge test results, participants were classified into two groups according to the presence or absence of bronchial hyperresponsiveness. The groups were subsequently compared with respect to restrospectively obtained data (age, gender, smoking status, comorbidities, laboratory parameters, and skin prick test results to inhalant allergens). Assessed laboratory parameters included C-reactive protein serum levels, ionized and total serum calcium, and 24-hour urinary calcium excretion.

The groups were additionally compared with respect to the radiological findings (obtained retrospectively). Radiological phenotypes were classified according to the predominant pattern of pulmonary abnormalities observed on chest HRCT, using a seven-category (1-7) Delphi HRCT Phenotype Classification designed in 2024. Sarcoidosis stages were determined according to the Scadding classification (stages 0-IV), both at the time of initial diagnosis and at the time of methacholine challenge testing. HRCT findings were used to improve the accuracy of radiological assessment compared to conventional chest radiography. Changes in pulmonary parenchymal abnormalities over time were classified as radiological progression, regression, stability, or de novo presentation. This assessment was based on chest HRCT examinations performed at the time of methacholine challenge testing and compared with previous examinations obtained 6-12 months earlier during follow-up hospital admissions. Patients diagnosed with sarcoidosis less than one week before methacholine challenge testing were classified as de novo cases, whereas patients diagnosed at least six months earlier were classified as having pre-existing sarcoidosis. Radiological phenotypes, Scadding stages, and changes in radiological findings over time were jointly assessed by two pulmonologists and one radiologist. Consensus was reached on all classifications reported in the study.

In the group with a positive metacholine test result, the analysis included an assessment of bronchial hyperresponsiveness severity in relation to all the parameters.

研究类型

观察性的

注册 (实际的)

70

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bydgoszcz、波兰、85-681
        • Clinical Department of Pulmonology, Allergology and Pulmonary Oncology, 10th Military Clinical Hospital with Polyclinic in Bydgoszcz, Poland

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients under the care of the Clinical Department of Pulmonology, Allergology, and Pulmonary Oncology at the 10th Military Clinical Hospital with Polyclinic in Bydgoszcz, Poland (between 11.2024 - 12.2025).

描述

Inclusion Criteria:

  • a confirmed diagnosis of sarcoidosis according to current ATS/ERS/WASOG guidelines,
  • availability of the required medical records,
  • ability to perform technically acceptable spirometry,
  • provision of written informed consent to participate in the study

Exclusion Criteria:

  • refusal to participate,
  • contraindications to methacholine bronchial challenge testing,
  • use of medications that could affect respiratory function without an adequate withholding period,
  • a prior diagnosis of asthma,
  • a respiratory tract infection within 8 weeks before the planned bronchial challenge test,
  • age under 18 years,
  • pregnancy and breastfeeding

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_CROSSOVER
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Group with bronchial hyperresponsiveness

Participants who exhibited at least a 20% decline in FEV1 at matacholine concentrations <16 mg/ml.

The metacholine challenge test protocol was developed in accordance with ATS/ERS recommendations. A 2-minute tidal breathing method with continuous inhalation of progressively increasing methacholine concentrations was used. Patients who exhibited less than a 20% decline in FEV1 at concentrations above 16 mg/ml were classified as having normal bronchial responsiveness. A provocative concentration of methacholine causing a 20% reduction in FEV1 (PC20) of 4-16 mg/ml was considered indicative of borderline BHR. Positive bronchial challenge responses were further classified according to the PC20 value as mild (1-4 mg/ml), moderate (0.25-1 mg/ml), or marked (< 0,25 mg/ml).

Group without bronchial hyperresponsiveness

Participants who exhibited less than a 20% decline in FEV1 at matacholine concentrations above 16 mg/ml.

The metacholine challenge test protocol was developed in accordance with ATS/ERS recommendations. A 2-minute tidal breathing method with continuous inhalation of progressively increasing methacholine concentrations was used. Patients who exhibited less than a 20% decline in FEV1 at concentrations above 16 mg/ml were classified as having normal bronchial responsiveness. A provocative concentration of methacholine causing a 20% reduction in FEV1 (PC20) of 4-16 mg/ml was considered indicative of borderline BHR. Positive bronchial challenge responses were further classified according to the PC20 value as mild (1-4 mg/ml), moderate (0.25-1 mg/ml), or marked (< 0,25 mg/ml).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prevalence of bronchial hyperresponsiveness in patients with sarcoidosis
大体时间:Periprocedural

The metacholine challenge tests were performed in all included participants (N=70). Eleven participants had been excluded earlier because they met the exclusion criteria, and therefore were not enrolled in the study.

Periprocedural

次要结果测量

结果测量
措施说明
大体时间
Correlation Between the Presence and Severity of Bronchial Hyperresponsiveness, Selected Laboratory Parameters and Atopy in Sarcoidosis
大体时间:Periprocedural

Data were obtained from the medical records of all included patients for laboratory parameters (N = 70) and from 63 patients for skin prick test results.

Periprocedural
Correlation Between the Presence and Severity of Bronchial Hyperresponsiveness and Pulmonary Radiological Findings in Sarcoidosis
大体时间:Through study completion, an average of 1 year

Data was obtained from medical records of all included patients (N=70).

Through study completion, an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Cezary Rybacki, PhD、Faculty of Medicine, Bydgoszcz University of Science and Technology, Bydgoszcz, Poland

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年11月1日

初级完成 (实际的)

2025年12月31日

研究完成 (实际的)

2025年12月31日

研究注册日期

首次提交

2026年10月23日

首先提交符合 QC 标准的

2026年10月30日

首次发布 (实际的)

2026年11月5日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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