NCT05843019

Adherence in Global Airways - Steroid Intake and Effects on Chronic Rhinosinosinutis

Adherence in Global Airways - the Relationship Between Steroid Intake and the Impact on the Endocrine Axis, Bone Density, and Structure in Patients With Chronic Sinusitis and Asthma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Christiane Haase · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the relationship between long-term use of systemic steroids in patients with upper and lower respiratory tract diseases and their own production of cortisol (cross-sectional), as well as whether those with low cortisol levels have an impact on bone density. As patients with CRSwNP have a high use of steroids, they routinely undergo a DEXA scan at the Respiratory Clinic, Department of Ear-Nose-Throat Surgery and Audiology (ENT) - Rigshospitalet (RH) to examine whether their bone density and structure are affected. The scan will be included as a clinical secondary outcome to assess whether systemic steroid use has an impact on this. The purpose of the study is therefore to compare steroid intake, baseline P-cortisol, the body's response to ACTH (measured by cortisol levels after the test), and bone density in patients with chronic sinusitis (CRS) with and without asthma in an unselected population at the Respiratory Clinic (cross-sectional). In addition, at the 4-month follow-up (exploratory follow-up, pilot project), it will be investigated whether good adherence (\>80%) to inhalation therapy (nasal steroid and lung steroid) and additional treatment with biologicals has a negative effect on the body's own production of P-cortisol.

Conditions

• Chronic Rhinosinusitis Without Nasal Polyps
• Asthma
• Chronic Rhinosinusitis With Nasal Polyps
• Steroid-Induced Osteopenia (Diagnosis)
• Steroid-Induced Diabetes
• Steroid-Induced Hyperglycemia

Timeline

• Start date: 2023-04-12
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-05-06
• Last updated: 2023-06-22

Locations

1 site across 1 country: Denmark