- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02826954
The Nasal Airway in Chronic Obstructive Pulmonary Disease (COPD)
The study is based on the theory of a "unified airway" that considers the nose and paranasal sinuses together with lower airways as one integrated unit. The upper and lower respiratory tracts function as an interdependent physiologic mechanism, and stimuli that trigger changes in one portion of the airway, can provoke similar changes throughout the airway. This is well documented in asthmatic patients but documented poorly in patients suffering from chronic obstructive lung disease (COPD).
COPD is associated with sinonasal symptoms and decreased quality of life. Although nasal involvement has been found to directly affect the lower airway, sinonasal disease is under-diagnosed and under-treated in patients with COPD. This study is embedded in a larger project where the goal is to gain knowledge supporting the theory of a "unified airway" in patients with COPD.
Here sinonasal, pulmonary and generic health related quality of life will be studied in a group of patients with COPD versus a control group. The severity of nasal airway obstruction will be linked to the the severity of pulmonary airway obstruction. Assessment of pathological changes in the nose with nasal endoscopy, as well as performing a nasal cytological brushing for the identification of nasal inflammatory responses in the nose, will be conducted in both the control and study group.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Trondheim, 노르웨이
- St. Olavs Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Diagnosis of COPD: all stages
- Healthy individuals for the control group
Exclusion Criteria both groups:
- asthma
- systemic disease such as Cystic Fibrosis, Kartagener syndrome, sarcoidosis
- upper airway infection during the last 2 weeks
- COPD exacerbation during the last 6 weeks
- previous surgery in the nose and paranasal sinuses
- ongoing treatment for malignant disease
- severe depression, Alzheimers disease and Parkinson's disease
- pregnancy or nursing
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
COPD patients
Self administered questionnaires regarding sinonasal and lung symptoms, quality of life as well as symptoms of depression and anxiety. Lower airway assessment using Spirometry with reversibility Upper airway assessment using Acoustic Rhinometry, Rhinomanometry and Peak nasal Inspiratory Flow Nasal biopsy using a nasal brush Nasal endoscopy Allergic prick-test |
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Healthy subjects
Self administered questionnaires regarding sinonasal and lung symptoms, quality of life as well as symptoms of depression and anxiety. Lower airway assessment using Spirometry with reversibility Upper airway assessment using Acoustic Rhinometry, Rhinomanometry and Peak nasal Inspiratory Flow Nasal biopsy using a nasal brush Nasal endoscopy Allergic prick-test |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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pathological changes in the nose assessed with nasal endoscopy
기간: 4 hours
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4 hours
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inflammatory responses in the nose identified by nasal cytological brushing
기간: 4 hours
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4 hours
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공동 작업자 및 조사자
수사관
- 연구 책임자: Wenche Thorstensen, PhD MD, Norwegian University of Science and Technology
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .