An observational study in Chronic Rhinosinusitis Without Nasal Polyps, Asthma and Chronic Rhinosinusitis With Nasal Polyps, sponsored by Christiane Haase. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Christiane Haase · Observational
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 80 is below the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Christiane Haase is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Inclusion Criteria: cross sectional study
Exclusion Criteria - cross sectional study
In/exclusion criteria for exploratory study - 4-month follow-up (pilot project)
Inclusion criteria:
Exclusion criteria:
Adherence:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
P kortisol
Changes in P-cortisol i bloodsample
Time frame: 4 month follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Started Apr 2023 (actual). Primary completion is estimated for Dec 2025, 32 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Christiane Haase