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临床试验/NCT05843019
NCT05843019招募中不适用

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

Christiane Haase1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
P kortisol

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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:
  • •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.

排除标准

  • 未提供

结局指标

主要结局

P kortisol

时间窗: 4 month follow-up

Changes in P-cortisol i bloodsample

次要结局

未报告次要终点

研究者

发起方
Christiane Haase
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christiane Haase

Clinical nurse specialist and Phd-student

Rigshospitalet, Denmark

研究点 (1)

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