Investigating the effects of steroid use on chronic rhinosinusitis and bone density
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
This study is testing how long-term steroid use affects people with chronic rhinosinusitis and asthma, focusing on their cortisol levels and bone density.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen, Denamrk) |
| Trial ID | NCT05843019 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between long-term systemic steroid use and cortisol production in patients with chronic rhinosinusitis (CRS) and asthma. It will assess how steroid intake correlates with baseline cortisol levels and the body's response to ACTH, as well as the impact on bone density through DEXA scans. The study will include patients diagnosed with CRS, both with and without asthma, to provide a comprehensive understanding of steroid effects on health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 diagnosed with chronic rhinosinusitis, with or without asthma, who have a history of systemic steroid use.
Not a fit: Patients who have never taken systemic steroids or those with severe psychiatric comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the risks associated with steroid use in patients with chronic respiratory conditions, leading to better management strategies.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated potential risks associated with long-term steroid use in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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/exclusion criteria for exploratory study - 4-month follow-up (pilot project) Inclusion criteria: * Diagnosed with CRS and possibly asthma * Age over 18 years * Low adherence: Foster score, i.e. the number of treatments taken compared to prescribed \< 80% (4 weeks out of 16 weeks) and/or measured on MARS-5 L/N ≤35 at the first visit (corresponding to less than 80%). If the patient does not have asthma, it is MARS-5N ≤ 19 * If asthma: ACQ ≥1.2 or ACT ≤ 17 (partly uncontrolled asthma) * SNOT-22 score ≥35 (partly uncontrolled CRS) * Participation in the cross-sectional study at the initial visit to the Respiratory Clinic Exclusion criteria: Adherence: * Foster score \>80% and/or on MARS-5-L/N \>35 points at the first visit * Cannot read or speak Danish * Severe psychiatric comorbidities * Patients who have never taken systemic steroids * After investigators' experience, will not be able to participate or comply with local treatment * Does not give permission to look up data in FMK-online.
Where this trial is running
Copenhagen, Denamrk
- Department of Otorhinolaryngology, Head and Neck Surgery & Audiology — Copenhagen, Denamrk, Denmark (Recruiting)
Study contacts
- Study coordinator: Christiane PS Haase
- Email: christiane.holbaek.haase.01@regionh.dk
- Phone: +4535459565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.