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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Upper airway assessment, including nasal biopsy

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St. Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Upper airway assessment, including nasal biopsy
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	Other: Upper airway assessment, including nasal biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pathological changes in the nose assessed with nasal endoscopy	4 hours
inflammatory responses in the nose identified by nasal cytological brushing	4 hours

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: University of Copenhagen; Haukeland University Hospital; St. Olavs Hospital
• Investigators: Study Director: Wenche Thorstensen, PhD MD, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Nasal Obstruction; Paranasal Sinus Diseases
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2015/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Biobank 1