Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMedical University of Vienna

About this trial

Asthma and chronic rhinosinusitis (CRS) are inflammatory diseases of the respiratory tract, asthma from the lower part, and CRS, from the upper part. In theory, these parts are correlated as if they are one single organ, namely "united airways", which means that if one is affected by any condition, the other might be impacted as well. However, this relationship has not yet been described down to the cellular and molecular levels. By investigating patients that have (1) asthma and CRS with nasal polyp, (2) asthma and CRS without nasal polyp, and (3) just CRS with nasal polyp, we aim to determine the correlation of the upper and lower part of the respiratory tract. At first, the characterization of disease will be determined by established clinical criteria, such as lung function, blood analysis for the presence of eosinophils (a type of white cells), and nasal polyp score. To continue, in-depth analysis of nose, oropharynx, and lung samples will help gain information about the inflammatory profile and local microbiome of the three different groups of patients through molecular and cellular assays. The results of this study will help to describe the hypothesis of the united airways which will provide better guidance for medical treatment of asthma and CRS with or without polyp, thus improving the life quality of patients.

Eligibility criteria

Qualifiers

18-99 years of age

have a recorded clinical diagnosis of asthma (ICD-10 Code: J45)

undergo moderate-serve asthma treatment according to GINA/DAL treatment step 4 or step 5 without oral corticosteroid or monoclonal antibody therapy

Asthma treatment for a minimum of 12 weeks prior to screening visit

Disqualifiers

Pregnancy (as determined by ß-HCG test)

Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity

Patients undergoing chronic oral corticosteroid therapy

Bronchiectasis, chronic obstructive pulmonary disorder (COPD), pulmonary fibrosis, emphysema, primary ciliary dyskinesia

Trial design

Treatments tested in this trial

  • Blood sampling
  • Nasosorption
  • Oral sampling
  • Bronchoscopy
  • Nasal biopsy
  • Nasal sampling
  • Nasal mucosa mRNA sampling
  • Pregnancy test
  • Medical history of patients, demographic data, concomitant medication, questionnaire
  • UPSIT smell test
  • Spirometry
  • FeNO
  • Lung X-Ray

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators