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

Asthma Clinical Trial

— AGAS 2023  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843019
• Other study ID #: 2022-ENT-steroids
• Status: Recruiting
• Start date: April 12, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Rigshospitalet, Denmark
• Contact: Christiane PS Haase
• Phone: +4535459565
• Email: christiane.holbaek.haase.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Bone Diseases, Metabolic
• Chronic Rhinosinusitis With Nasal Polyps
• Chronic Rhinosinusitis Without Nasal Polyps
• Hyperglycemia
• Nasal Polyps
• Polyps
• Sinusitis

Locations

Country	Name	City	State
Denmark	Department of Otorhinolaryngology, Head and Neck Surgery & Audiology	Copenhagen	Denamrk

Sponsors (1)

Lead Sponsor	Collaborator
Christiane Haase

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P kortisol	Changes in P-cortisol i bloodsample	4 month follow-up