Adherence in Global Airways - Steroid Intake and Effects on Chronic Rhinosinosinutis (AGAS 2023)

June 21, 2023 updated by: Christiane Haase

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients referred to the Respiratory Clinic, ENT, RH, for evaluation of CRS/CRSwNP/CRSnNP and with or without asthma for biological treatment. They are classified according to the type of inflammation they have (type-2 or non-type-2), whether they have CRSwNP or CRSsNP, their adherence, comorbidity with asthma, and finally the severity of the disease. All patients are given standard questionnaires to assess CRS/CRSwNP/CRSnNP and asthma (STARR-15, SNOT22, ACQ, ACT, MARS-5-L/N, Fosterscore - routine questionnaires for all patients in the Respiratory Clinic).

Patients for the project are recruited at the initial visit to the Respiratory Clinic. A nurse from the Respiratory Clinic will inform about the project and ask if the patient is interested in participating. If the patient is interested, a meeting will be arranged with a researcher from the research group (see section on information).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cross sectional

The patients in the cross sectional study will have done a synactenstest to investigate how their own product of kortisol os after longterm use of systemic steroids.

The group consists of patients referred to the Respiratory Clinic, ENT, RH, for evaluation of CRS/CRSwNP/CRSnNP and with or without asthma for biological treatment. They are classified according to the type of inflammation they have (type-2 or non-type-2), whether they have CRSwNP or CRSsNP, their adherence, comorbidity with asthma, and finally the severity of the disease. All patients are given standard questionnaires to assess CRS/CRSwNP/CRSnNP and asthma (STARR-15, SNOT22, ACQ, ACT, MARS-5-L/N, Fosterscore - routine questionnaires for all patients in the Respiratory Clinic).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P kortisol
Time Frame: 4 month follow-up
Changes in P-cortisol i bloodsample
4 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiane Haase

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-ENT-steroids

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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