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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Trondheim, Noorwegen
- St. Olavs Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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pathological changes in the nose assessed with nasal endoscopy
Tijdsspanne: 4 hours
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4 hours
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inflammatory responses in the nose identified by nasal cytological brushing
Tijdsspanne: 4 hours
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4 hours
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Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Wenche Thorstensen, PhD MD, Norwegian University of Science and Technology
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2015/2017
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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