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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05843019
Acronym
AGAS 2023
Enrollment
80
Registered
2023-05-06
Start date
2023-04-12
Completion date
2025-12-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Adherence, Nurse, Global airways, Steroids

Brief 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.

Interventions

None listed

Sponsors

Christiane Haase
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

cross sectional study * Diagnosed with chronic rhinosinusitis (CRS) * possibly asthma * Aged over 18 years

Exclusion criteria

- cross sectional study * Unable to read or speak Danish * Presence of severe psychiatric comorbidities * Patients who have never taken systemic steroids * Inability to participate or comply with local treatment according to the investigators' assessment * Does not provide consent for lookup in FMK-online In/

Design outcomes

Primary

MeasureTime frameDescription
P kortisol4 month follow-upChanges in P-cortisol i bloodsample

Countries

Denmark

Contacts

Primary ContactChristiane PS Haase
christiane.holbaek.haase.01@regionh.dk+4535459565
Backup ContactVibeke P Backer
nina.vibeke.backer@regionh.dk+4535456033

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026