The Nasal Airway in Chronic Obstructive Pulmonary Disease

NCT ID: NCT02826954

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-11-30

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

Upper airway assessment, including nasal biopsy

Intervention Type: OTHER

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

Upper airway assessment, including nasal biopsy

Intervention Type: OTHER

Interventions

Upper airway assessment, including nasal biopsy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of COPD: all stages
• Healthy individuals for the control group

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenche Thorstensen, PhD MD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

St. Olavs Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

2015/2017

Identifier Type: -

Identifier Source: org_study_id