Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Bronchial Hyperresponsiveness in Sarcoidosis

30 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

70

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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).

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: CASE_CROSSOVER
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Prevalence of bronchial hyperresponsiveness in patients with sarcoidosis
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation Between the Presence and Severity of Bronchial Hyperresponsiveness, Selected Laboratory Parameters and Atopy in Sarcoidosis
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Cezary Rybacki, PhD, Faculty of Medicine, Bydgoszcz University of Science and Technology, Bydgoszcz, Poland

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 novembre 2024

Achèvement primaire (Réel)

31 décembre 2025

Achèvement de l'étude (Réel)

31 décembre 2025

Dates d'inscription aux études

Première soumission

23 octobre 2026

Première soumission répondant aux critères de contrôle qualité

30 octobre 2026

Première publication (Réel)

5 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner