An observational study in Asthma (Diagnosis), Sarcoidosis and Bronchial Hyperresponsiveness, sponsored by Bydgoszcz University of Science and Technology. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Bydgoszcz University of Science and Technology · Observational
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 70 is below the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Bydgoszcz University of Science and Technology is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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).
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who exhibited at least a 20% decline in FEV1 at matacholine concentrations \<16 mg/ml.
Diagnostic Test: Bronchial metacholine challenge test
Participants who exhibited less than a 20% decline in FEV1 at matacholine concentrations above 16 mg/ml.
Diagnostic Test: Bronchial metacholine challenge test
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).
Prevalence of bronchial hyperresponsiveness in patients with sarcoidosis
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.
Time frame: Periprocedural
Correlation Between the Presence and Severity of Bronchial Hyperresponsiveness, Selected Laboratory Parameters and Atopy in Sarcoidosis
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.
Time frame: Periprocedural
Correlation Between the Presence and Severity of Bronchial Hyperresponsiveness and Pulmonary Radiological Findings in Sarcoidosis
Data was obtained from medical records of all included patients (N=70).
Time frame: Through study completion, an average of 1 year
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Bydgoszcz University of Science and Technology