Clinical trial NCT02826954: The Nasal Airway in Chronic Obstructive Pulmonary Disease
Official title: The Nasal Airway in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Paranasal Sinus Diseases
Nasal Obstruction
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Haukeland University Hospital
name: University of Copenhagen
First posted: 2016-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with chronic obstructive pulmonary disease (COPD) in St Olavs Hospital, Trondheim, Norway, and healthy participants matched in age and sex.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: pathological changes in the nose assessed with nasal endoscopy
timeFrame: 4 hours
measure: inflammatory responses in the nose identified by nasal cytological brushing
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Wenche Thorstensen, PhD MD
role: STUDY_DIRECTOR
References: