Bronchial Hyperresponsiveness in Sarcoidosis

October 30, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_CROSSOVER
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group with bronchial hyperresponsiveness

Participants who exhibited at least a 20% decline in FEV1 at matacholine concentrations <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).
Group without bronchial hyperresponsiveness

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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of bronchial hyperresponsiveness in patients with sarcoidosis
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between the Presence and Severity of Bronchial Hyperresponsiveness, Selected Laboratory Parameters and Atopy in Sarcoidosis
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bydgoszcz University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cezary Rybacki, PhD, Faculty of Medicine, Bydgoszcz University of Science and Technology, Bydgoszcz, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6/2024/KB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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