The Nasal Airway in Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

— COPD  

Official title:

The Nasal Airway in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826954
• Other study ID #: 2015/2017
• Status: Completed
• Start date: February 2016
• Est. completion date: November 2017

Study information

• Verified date: March 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Upper airway assessment, including nasal biopsy

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Haukeland University Hospital, St. Olavs Hospital, University of Copenhagen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological changes in the nose assessed with nasal endoscopy		4 hours
Primary	inflammatory responses in the nose identified by nasal cytological brushing		4 hours