Adherence in Global Airways - Steroid Intake and Effects on Chronic Rhinosinosinutis (NCT05843019) | Clinical Trial Compass
UnknownNot Applicable
Adherence in Global Airways - Steroid Intake and Effects on Chronic Rhinosinosinutis
Denmark80 participantsStarted 2023-04-12
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.